EL2105973 Rev A – Abbott Vascular Absorb GT1 Bioresorbable Vascular Scaffold System

136 Pages·2015·31.94 MB·English

Absorb GT1
Bioresorbable Vascular Scaffold System
EN English IT Italiano HU Magyar
DE Deutsch FI Suomi BG Български
SV Svenska FR Français RO Română
DA Dansk ES Español SK Slovensky
PL Polski RU Pусский ET Eesti keel
CS Česky PT Português LV Latviešu
TR Türkçe NL Nederlands LT Lietuvių
NO Norsk EL Ελληνικά SL Slovenščina
Graphical Symbols for Medical Device Labeling; Grafische Symbole zur Beschriftung von Medizinprodukten; Symboles graphiques pour l‘étiquetage des dispositifs
médicaux ; Símbolos gráficos utilizados en el etiquetado de productos sanitarios; Simboli grafici per l’etichettatura di dispositivi medicali; Símbolos Gráficos para
Rotulagem de Dispositivos Médicos; Grafiska symboler för märkning av medicinsk utrustning; Grafische symbolen voor de etikettering van medische hulpmiddelen;
Grafiske symboler beregnet til mærkning af medicinske produkter; Γραφικά σύμβολα για τη σήμανση ιατρικών συσκευών; Symbole graficzne do oznaczania sprzętu
medycznego; Grafikus szimbólumok orvosi eszközök címkézéséhez; Grafické symboly k označení zdravotnického prostředku; Tıbbi Cihaz Etiketleri İçin Grafik
Semboller; Grafické symboly na označovanie zdravotníckej pomôcky; Графични символи за етикетиране на медицински уреди; Simboluri grafice pentru
etichetarea dispozitivelor medicale; Графические символы на этикетках медицинских изделий; Lääketieteellisten laitteiden tuotetarroissa esiintyvät symbolit;
Grafiske symboler for merking av medisinsk utstyr
Meditsiiniseadme märgistuse graafilised sümbolid; Grafiskie simboli medicīnisko ierīču apzīmēšanai; Medicinos prietaisų etikečių grafiniai simboliai; Grafični
simboli za označevanje medicinskega pripomočka
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Graphical Symbols for Medical Device Labeling; Grafische Symbole zur Beschriftung von Medizinprodukten; Symboles graphiques pour l‘étiquetage des dispositifs médicaux ; Símbolos
gráficos utilizados en el etiquetado de productos sanitarios; Simboli grafici per l’etichettatura di dispositivi medicali; Símbolos Gráficos para Rotulagem de Dispositivos Médicos;
Grafiska symboler för märkning av medicinsk utrustning; Grafische symbolen voor de etikettering van medische hulpmiddelen; Grafiske symboler beregnet til mærkning af medicinske
produkter; Γραφικά σύμβολα για τη σήμανση ιατρικών συσκευών; Symbole graficzne do oznaczania sprzętu medycznego; Grafikus szimbólumok orvosi eszközök címkézéséhez;
Grafické symboly k označení zdravotnického prostředku; Tıbbi Cihaz Etiketleri İçin Grafik Semboller; Grafické symboly na označovanie zdravotníckej pomôcky; Графични символи за
етикетиране на медицински уреди; Simboluri grafice pentru etichetarea dispozitivelor medicale; Графические символы на этикетках медицинских изделий; Lääketieteellisten
laitteiden tuotetarroissa esiintyvät symbolit; Grafiske symboler for merking av medisinsk utstyr
MANUFACTURED BY
Manufacturer; Hersteller; Fabricant ; Fabricante; Produttore; Fabricante; Tillverkare; Fabrikant; Manufactured by; Hergestellt von; Fabriqué par ; Fabricado por; Prodotto da; Fabricado Guiding catheter; Führungskatheter; Cathéter-guide ; Catéter guía; Catetere guida;
Producent; Κατασκευαστής; Producent; Gyártó; Výrobce; İmalatçı; Výrobca; Производител; por; Tillverkad av; Vervaardigd door; Fremstillet af; Κατασκευάζεται από; Wyprodukowano Cateter-Guia; Guidekateter; Geleidekatheter; Guidingkateter; Οδηγός καθετήρας; Cewnik
Producător; Производитель; Valmistaja; Tilvirker przez; Gyártó; Výrobce; İmal eden; Výrobca; Произведено от; Produs de; Произведено; prowadzący; Vezetőkatéter; Vodicí katetr; Kılavuz Kateter; Vodiaci katéter; Водещ катетър;
Valmistaja; Produsert av Cateter de ghidare; Проводниковый катетер; Ohjainkatetri; Ledekateter
Catalogue number; Katalog-Nr.; N° de référence ; N.º de referencia; N. di catalogo; Número Consult instructions for use; Gebrauchsanweisung lesen; Consulter le mode d‘emploi ;
de catálogo; Katalognr; Catalogusnummer; Katalognummer; Αριθμός καταλόγου; Numer Consultar las instrucciones de uso; Consultare le istruzioni per l’uso; Consultar as instruções
katalogowy; Katalógusszám; Katalogové číslo; Katalog numarası; Katalógové číslo; de utilização; Se bruksanvisningen; Raadpleeg gebruiksaanwijzing; Læs brugsanvisningen;
Каталожен номер; Număr de catalog; Каталожный номер; Tuotenumero; Katalognummer Συμβουλευτείτε τις οδηγίες χρήσης; Zapoznać się z instrukcją obsługi; Lásd a használati
utasítást; Viz návod k použití; Kullanım talimatlarına bakın; Pozri návod na použitie;
Вижте инструкциите за употреба; Consultaţi instrucţiunile de utilizare; Ознакомьтесь с
инструкциями по применению; Katso käyttöohjeita; Les bruksanvisningen
Excursions permitted to temperature; Temperaturabweichungen erlaubt bis: Expositions
autorisées à cette température ; Oscilaciones permitidas de temperatura; Escursioni termiche
ammesse fino alla temperatura: Amplitude de temperatura permitida; Temperaturavvikelser
tillåtna till; Toegestane temperatuurschommelingen; Udsving tilladt for temperatur;
Επιτρεπόμενες διακυμάνσεις θερμοκρασίας; Dopuszczalne odchylenia temperatury;
Megengedett hőmérsékleti tartomány; Odchylky dovoleny do teploty; Sevkiyat sırasında
izin verilen maksimum sıcaklık; Výchylky sú dovolené do teploty; Допустими отклонения
French size; French-Größe; Taille en French ; Calibre French; Calibro in French; Tamanho на температурата; Deviaţii permise până la temperatura de; Допустимый диапазон
em French (F); French-storlek; Maateenheid French; French størrelse; Μέγεθος σε French; температур; Lämpötilan poikkeamiset sallittu; Avvik tillatt til temperatur
Rozmiar [F]; French méret; Velikost (French); French boyutu; Francúzsky rozmer; Френски
размер; Dimensiune franceză; «Французская» шкала размеров или шкала Шаррьера;
Fr-koko; “French”-størrelse
Contents (numeral represents quantity of units inside); Inhalt (Zahl steht für Anzahl der
enthaltenen Einheiten); Contenu (le chiffre représente le nombre d‘unités à l‘intérieur) ;
Contenido (la cifra representa la cantidad de unidades que contiene); Contenuto (il numero
indica il quantitativo presente all’interno); Conteúdo (o número representa a quantidade de
unidades no interior); Innehåll (siffran avser antalet enheter i förpackningen); Inhoud (het
getal geeft het aantal aanwezige eenheden aan); Indhold (tallet viser antallet af enheder
indeni); Περιεχόμενο (Ο αριθμός αντιπροσωπεύει την ποσότητα των μονάδων που
εσωκλείονται); Zawartość (podany numer oznacza liczbę sztuk wewnątrz); Tartalom (a
feltüntetett szám a csomagban lévő egységek mennyiségét jelzi); Obsah (číslo udává počet
Do not reuse; Nicht wiederverwenden; Ne pas restériliser ; No volver a utilizar; Monouso; kusů v balení); İçindekiler (sayı, ambalajdaki ünite miktarını gösterir); Obsah (číslo vyjadruje
Não reutilizar; Får ej återanvändas; Niet opnieuw gebruiken; Må ikke genbruges; Μην το počet kusov v balení); Съдържание (брой елементи в пакета); Conţinut (numărul reprezintă Rapid Exchange; Rapid Exchange; Échange rapide ; Intercambio rápido; Scambio rapido;
επαναχρησιμοποιείτε; Nie używać ponownie; Tilos ismételten felhasználni!; Nepoužívejte cantitatea de unităţi din interior); Комплектация (число обозначает количество предметов Troca Rápida; Rapid Exchange (snabbutbyte); Snelle verwisseling; Hurtig udskiftning; Ταχεία
opakovaně; Tekrar kullanmayın; Nepoužívajte opätovne; Не използвайте повторно; A nu se в упаковке); Sisältö (numero ilmaisee sisällä olevien yksikköjen määrää); Innhold (tallet ανταλλαγή; Szybka wymiana; Gyorscserés; Rychlovýměnné; Hızlı Değiştirme; Rýchla
reutiliza; Для одноразового использования; Ei saa käyttää uudelleen; Må ikke gjenbrukes viser antallet indre enheter) výmena; Бърза смяна; Schimbare rapidă; Система быстрой замены (монорельсовая);
RX-sisäänvientijärjestelmä; Rask utskiftning
STERILIZE
Do not resterilize; Nicht resterilisieren; Ne pas réutiliser ; No volver a esterilizar; Non Sterilized using irradiation; Strahlensterilisiert; Stérilisé par irradiation ; Esterilizado por Non-pyrogenic; Nicht pyrogen; Apyrogène ; Apirógeno; Apirogeno; Apirogénico; Icke
risterilizzare; Não reesterilizar; Får ej omsteriliseras; Niet opnieuw steriliseren; Må ikke irradiación; Sterilizzato usando radiazioni; Esterilizado por radiação; Steriliserad med pyrogen; Niet-pyrogeen; Non-pyrogen; Μη πυρετογόνο; Niepirogenne; Nem pirogén;
resteriliseres; Μην το επαναποστειρώνετε; Nie resterylizować; Tilos újrasterilizálni!; strålning; Gesteriliseerd door bestraling; Steriliseret med bestråling; Αποστειρωμένο με Nepyrogenní; Pirojenik değildir; Nepyrogénne; Непирогенен; Apirogen; Апирогенно;
Nesterilizujte; Tekrar sterilize etmeyin; Nesmie sa resterilizovať; Не стерилизирайте ακτινοβολία; Sterylizowane radiacyjnie; Besugárzással sterilizált; Sterilizováno ozářením; Pyrogeenitön; Ikke-pyrogen
повторно; A nu se resteriliza; Не подлежит повторной стерилизации; Ei saa steriloida Radyasyonla sterilize edilmiştir; Sterilizované ožiarením; Стерилизиран с облъчване;
uudelleen; Må ikke resteriliseres Sterilizat prin iradiere; Стерилизовано излучением; Steriloitu sädettämällä; Sterilisert med
bestråling
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Inner diameter; Innendurchmesser; Diamètre interne ; Diámetro interno; Diametro
interno; Diâmetro interno; Innerdiameter; Binnendiameter; Indvendig diameter; Εσωτερική
Separate collection for waste electrical / electronic equipment; Gescheiden inzameling διάμετρος; Średnica wewnętrzna; Belső átmérő; Vnitřní průměr; İç çap; Vnútorný priemer;
van afgedankte elektrische/elektronische apparatuur; Collecte séparée des déchets Вътрешен диаметър; Diametru interior; Внутренний диаметр; Sisäläpimitta;
d'équipements électriques / électroniques ; Recogida por separado de residuos eléctricos/ Indre diameter
equipo electrónico; Smaltire separatamente come rifiuto elettrico/elettronico; Recolha
separada de resíduos de equipamentos eléctricos / electrónicos; Separat insamling av avfall
från elektrisk/elektronisk utrustning; Gescheiden inzameling van afgedankte elektrische/
elektronische apparatuur; Separat indsamling for eletronisk affald / elektronisk udstyr
equipment; Χωριστή συλλογή αποβλήτων ειδών ηλεκτρικού και ηλεκτρονικού εξοπλισμού;
Oddzielna zbiórka zużytego sprzętu elektrycznego/elektronicznego; Elektromos/elektronikus
berendezések hulladékainak szelektív gyűjtése; Separovaný sběr odpadu z elektrických/
elektronických zařízení; Atık elektrikli / elektronik cihazlar için ayrı toplama; Separovaný zber
elektrického a elektronického odpadu; Разделно събиране на отпадъчно електрическо/
електронно оборудване; Colectare separată pentru deșeuri de echipamente electrice/
electronice; Раздельный сбор отходов (электрического и электронного оборудования);
Erillinen jätteenkeräys sähkö- ja elektroniikkaromulle; Separat avfallsinnsamling for elektrisk/
elektronisk utstyr CAUTION: Consult instructions for use for warnings and precautions; VORSICHT
– Warnungen und Vorsichtsmaßnahmen entnehmen Sie bitte der entsprechenden
Gebrauchsanweisung; ATTENTION – Consulter le mode d’emploi pour connaître les
avertissements et les précautions ; PRECAUCIÓN: Consulte las instrucciones de uso
para conocer las advertencias y precauciones que debe tener en cuenta; ATTENZIONE
- Consultare le istruzioni per l'uso relativamente ad avvertenze e precauzioni; ATENÇÃO
– Consulte as instruções de utilização para as advertências e precauções; OBSERVERA:
Se bruksanvisningen för varningar och försiktighetsåtgärder; VOORZICHTIG: Raadpleeg
de gebruiksaanwijzing voor waarschuwingen en voorzorgsmaatregelen; FORSIGTIG – Se
brugsanvisningen for advarsler og forsigtighedsregler; ΠΡΟΣΟΧΗ – Συμβουλευτείτε τις
οδηγίες χρήσης για προειδοποιήσεις και προφυλάξεις. UWAGA: W celu zaznajomienia
Use by; Verwenden vor; Date limite ; Fecha de caducidad; Data di scadenza; Usar até; Bäst się z ostrzeżeniami i środkami ostrożności, prosimy zapoznać się z instrukcję obsługi;
före; Uiterste gebruiksdatum; Anvendes inden; Χρήση έως; Termin przydatności do użycia; VIGYÁZAT! – A figyelmeztetéseket és az óvintézkedéseket illetően olvassa el a használati
A szavatosság lejár; Použít do; Son Kullanım Tarihi; Použiť do; Годен до; Valabil până la; utasítást; POZOR: Prostudujte si návod k použití, kde naleznete varování a bezpečnostní
Использовать до; Viimeinen käyttöpäivä; Brukes innen upozornění; DİKKAT – Uyarı ve önlemler için kullanım kılavuzuna başvurun; UPOZORNENIE:
Preštudujte si používateľskú príručku, kde nájdete varovania a bezpečnostné upozornenia;
ПРЕДУПРЕЖДЕНИЕ: вижте инструкциите за употреба за предупрежденията и
предпазните мерки; ATENŢIE: Consultaţi instrucţiunile de utilizare pentru avertizări și
măsuri de precauţie; ВНИМАНИЕ: предупреждения и меры предосторожности см. в
инструкциях по применению; HUOMIO: Katso varoitukset ja varotoimet käyttöohjeista;
25oC FORSIKTIG – Se bruksanvisningen for informasjon om advarsler og forholdsregler
(77oF)
Upper limit of temperature; Obere Temperaturgrenze; Limite supérieure de température ;
Límite superior de temperatura; Limite superiore di temperatura; Limite superior de
temperatura; Övre temperaturgräns; Bovenste temperatuurlimiet; Øvre temperaturgrænse;
Άνω όριο θερμοκρασίας; Górna granica temperatury; A hőmérséklet felső határa;
Horní limit teploty; Üst sıcaklık sınırı; Horná hranica teploty; Горна граница на
температурата; Limita superioară de temperatură; Верхний предел температуры;
Lämpötilan yläraja; Øvre temperaturgrense
MR
MR Safe; MR-sicher; Compatible avec l'IRM ; Seguro con RM; Sicuro per la RM; Seguro
com procedimentos de RM; MR-säker; MR-veilig; MR-sikker; Ασφαλές για μαγνητική
Date of manufacture; Herstellungsdatum; Date de fabrication ; Fecha de fabricación; Data τομογραφία; Bezpieczne w rezonansie magnetycznym (MR); MR környezetben biztonságos;
di produzione; Data de fabrico; Tillverkningsdatum; Productiedatum; Fremstillingsdato; Bezpečné při vyšetření MR; MR Güvenli; Vhodný pre MR; Безопасен при ЯМР; Sigur pentru
Ημερομηνία κατασκευής; Data produkcji; A gyártás dátuma; Datum výroby; Üretim RMN; Безопасен в МР-окружении; MRI-turvallinen; MR-sikker
tarihi; Dátum výroby; Дата на производство; Data fabricaţiei; Дата изготовления;
Valmistuspäivämäärä; Tilvirkningsdato
Batch code; Chargencode; No de lot ; Código de lote; Codice Lotto; Código do lote;
Batchnummer; Partijnummer; Partinummer; Αριθμός παρτίδας; Kod partii; Tételazonosító
kód; Kód dávky; Parti Kodu; Kód výrobnej šarže; Партиден номер; Codul lotului; Номер
серии; Eräkoodi; Produksjonsnummer
Do not use if package is damaged; Das Produkt nicht verwenden, wenn die Packung
beschädigt ist; Ne pas utiliser ce produit si l‘emballage est endommagé ; No utilizar el
producto si el envase está dañado; Non utilizzare se la confezione è danneggiata; Não
utilizar se a embalagem estiver danificada; Använd inte produkten om förpackningen är
skadad; Gebruik het product niet als de verpakking beschadigd is; Må ikke anvendes,
hvis pakningen er beskadiget; Μη χρησιμοποιείτε το προϊόν, εάν η συσκευασία είναι
κατεστραμμένη; Nie używać, jeśli opakowanie zostało uszkodzone; Ne használja, ha
a csomagolás sérült!; Nepoužívejte, je-li obal poškozen; Ambalaj hasar görmüşse
Outer diameter; Außendurchmesser; Diamètre externe ; Diámetro externo; Diametro esterno; kullanmayın; Nepoužívajte, ak je obal poškodený; Не използвайте, ако пакетът
Diâmetro Externo; Ytterdiameter; Buitendiameter; Udvendig diameter; Εξωτερική διάμετρος; е повреден; Nu utilizaţi dacă ambalajul este deteriorat; Не использовать, если упаковка
Średnica zewnętrzna; Külső átmérő; Vnější průměr; Dış çap; Vonkajší priemer; Външен повреждена; Ei saa käyttää, jos pakkaus on vaurioitunut; Må ikke brukes hvis emballasjen
диаметър; Diametru exterior; Внешний диаметр; Ulkoläpimitta; Ytre diameter er skadet
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English 1.0 DEVICE DESCRIPTION • This product should not be used in patients who are not likely to comply with the
The Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System includes: recommended antiplatelet therapy.
Absorb GT1 • Aan ptirper-omlifoeuranttievde pdorulygm eevre rpoolilmy u(Ls- laancdti dpeo)l y(mPLeLrA p)o slyc a(Dff,oLl-dla ccotiadtee)d (wPDithL LaA b) leinn da o1f: 1t hrea tio. • Jausdsoiccioiautesd s erilsekc toiof ns coaf fpfoaltdie tnhtrso mis bnoesciess, svaarsyc, uslianrc ceo tmhep luicsaet ioofn tsh, isa ndde v/ icoer bclaererdieins gt he
The available dose of everolimus on the scaffold is shown in Table 1. events.
Bioresorbable Vascular Scaffold System Table 1: Drug Content in Absorb GT1 BVS • Oasraslo acdiamteidn iswtritaht ioinnc roefa esveedr osleimruums icnh coolemstbeirnoal taionnd wtriitghl yccyecrliodsepso. rTinhee rheafosr eb,e peant ients
INFORMATION FOR PRESCRIBERS Scaffold Diameter Scaffold Length Drug Dose should be monitored for changes in lipid profiles.
Table of Contents (mm) (mm) (μg) • Persons allergic to poly (L-lactide), poly (D,L-lactide), everolimus, or platinum may
1.0 DEVICE DESCRIPTION 2.5, 3.0 8 76 • sItu ifsf enro at nr eaclloemrgmice rnedaecdti oton ttroe atht ips aitmiepnltasn ht.aving a lesion with excessive tortuosity
Table 1: Drug Content in Absorb GT1 BVS 2.5, 3.0 12 114 proximal to or within the lesion.
Table 2: In Vitro Device Specifications 2.5, 3.0 18 181 • Devices (i.e., guide sheaths) that decrease the inner diameter of the guide catheter
23..00 HINODWIC ASTUIPOPNLSIED 2.5, 3.0 23 228 o(Tuatbsildee 2 o) fm thues tA nbosto brbe GusTe1d B wViSth S tyhset eAmbs moribn iGmTu1m B gVuSi dSey csatetmhe.t eDro c noomt pinastiebritli tay 5 -in-6,
4.0 CONTRAINDICATIONS 2.5, 3.0 28 276 or a 6-in-7 guide sheath into a 6F or 7F guiding catheter, as doing so will result in an
56..00 WPRAERCNAINUGTISO NS 3.5 12 135 • iBnanleloro dni admilaettaetri othna ot fi sa ntoyo c semllsa lol ff oar duespel owyeitdh Athbes Aorbbs oGrTb1 G BTV1S B mVSa yS cyasutesme .scaffold
6.1 Scaffold Handling – Precautions 3.5 18 197 damage.
6.2 Scaffold Placement – Precautions 3.5 23 246 • Careful selection of the target lesion reference vessel diameter to the scaffold diameter,
66..34 UScsaef fino ldC o/ nSjuynsctetmion R wemitho vOathl e–r PPrreoccaeudtuiorness 3.5 28 308 amnidn imadizeeq upaottee nletsiaiol dna pmreapgaer atoti otnh ep sricoar ftfoo lsdc dauffroinldg ipmlapclaenmtaetniot.n I ti sis r encoot mremcoemndmede ntdoe d to
6666....5678 PMDPorrReusgIgt nS IImantantpetcelryamancett in–ot nPsr ecautions • FlBeoVnuSgrt hirsa pdnriooiotp rva tiqosu ibdele emp ulaonrydkmeerres nf lltuo oacnraodtse cadfo topenry .ethxep aennsdio rnin igns t hoef tahrete sryc abffeocladu msea rtkh eth Aeb sscoarfbf oGldT 1 t(lereesxaiaotm np pawlteiiet:h na tg ssr eehavaetverirne lgtyh aac nale l4csi0ifoi%end rt helesasitd iopunrae ltv hseatnett nsho acssoi smn oapftlt eehtrae dp i rnaefddlaeiltqaiotuanat tiooef n lae bnsyi oa vnni gspuioraeplp laeassrattyitmi obanat)li,loo noo.rn a
7.0 ADVERSE EVENTS • Two radiopaque markers, located underneath the balloon, fluoroscopically mark the 6.0 PRECAUTIONS
7.1 Observed Adverse Events working length of the balloon and the location of the undeployed scaffold of the 6.1 Scaffold Handling – Precautions
8.0 7C.L2I NICPAoLt eINntViaElS ATdIGveArTsIeO NESve OntFs ABSORB BVS SYSTEM • sAcbasfoforbld G dTe1li vBeVryS sSyysstetemm. has a rapid exchange (RX) scaffold delivery system. • F“Uors es ibnyg”le d uatsee ,o nsi nthgel ep aincskeargteio.n only. Do not resterilize or reuse. Note the product
88..12 88AA..BB22SS..12OO RRBBMC CCleinlotinhihcioocadral tol O AlTou rgticayol amned aCt u5r rYeenat rSstatus •• TtgAiwpu s)iod hi inapndfrgtoi ccxcaoiamtlteoha retl h tcdeeher .arl ieWnvlgeaoretyri vk deisne ypngsoo tcesteamitstiho tsenhht eeoa rffg t l utemhnidegae tdr hkwe eliiisrrvse e1 r(e4y9x5 5ist yccnsmmotet. cmahn .dto 1 t0h5e ecnmd porfo bxirmacahl iatol othr ef edmisotaral l •• DspTcehoari sfnfo foodrmteld lri evtaoemngrdyoe vt/sh eyoe srtr ht leaeemsa s d acs tahsofyo fssouctlleddam fnffro.ooltdm b e etmh uebs oedldeiz laiinvti eocrnoy.n sTjuyhnsect etsimocna, fafwosil tdrhe smoytsohtveearm ls m tiesan yitns td.eanmdeadg et ot he
8.3 888A...B222S...345O RBTFDAV aCianigsbsoguclohieruomeo sg3 r1sor:ta i:toCB opnSR rlhi ncieFciasuc, funaIflVoclt stlUOdi oSouentd,fc ,aAR onacemndesd etuOy lDatlCcstih T s5ao ttOa l Yil2nu eS etaYce reaosganmmrdsee Msn taestt h1e8rg0i nDea Tyess atinndg 2in Y Peraorxsimal, DSi(camamfmfeot)ledr SL(cemanfmgfot)hld TaCGboluem*i d2 piM:na gtIiinn bCi imVlaiittutyhmr eo(t I eDDr)e vicea* tSP*NSmpr coIeeanmscf sfiiVofnuikilacrtdPerla ao ti onsaRPtamreteRsdsB uBPrkuePr as–t ScAF(ar%rfeefe)oa l d •• SboaDcbnoaavpoedllae lloornt c igooontiauhnngtl ie .. dm cd Tignaaahurgmneii sdi cap meiagus tewul ha,ms eitrctetoe eob,,sr net at tho naitmuuadmbck paie.hnodn,ar vottnaairoonn nhttc ,ated oonmu rdhr eildanenings tdt lhtcolheeadr togohsuerce mgatinehfer f a notrhntle deymo frwwo otivthatahayet l i yndsforgciosu armhrfu fefop mipntld agot chesfkrertoaas smgt,i ccia na tsghvf f,aeto hl plvdidlseae oclmaivnedeam atryhpye etc ne atr u se
88..33..12 MCleinthicoadl oOlougtcyo amneds C fourr rFeunltl SCtoahtuosrt B 2.5 8 6F (0.070"/1.8 mm) 6 608 16 1621 68 • Use only the appropriate balloon inflation media. Do not use air or any gaseous
Table 4: Hierarchical Clinical Outcomes for Cohort B (ITT Population) 2.5 12 6F (0.070"/1.8 mm) 6 608 16 1621 68 medium to inflate the balloon, as this may cause uneven expansion and difficulty in
88..33..34 DAnisgciuosgsraiopnhic, IVUS, and OCT Outcomes at 180 Days, 1, 2, and 3 Years 2.5 18 6F (0.070"/1.8 mm) 6 608 16 1621 68 • dImepplloaynmtateiontn ooff tthhee ssccaaffffooldld. should be performed only by physicians who have
8.4 ABSORB EXTEND 2.5 23 6F (0.070"/1.8 mm) 6 608 16 1621 68 received appropriate training.
88..44..12 MSuemthmodaorylo ogfy Calnindic Caul rRreenstu lStsta otuust to 1 year (Interim Data Cutoff) 2.5 28 6F (0.070"/1.8 mm) 6 608 16 1621 68 • Scocraofnfoalrdy palartceerym beynpt asshso uglrda fot nsluyr gbeer py e(rCfoArBmGe)d i sa ta hvoasilapbitlael.s where access to emergency
Table 5: ABSORB EXTEND Subject Counts of Ischemia-driven Adverse 3.0 8 6F (0.070"/1.8 mm) 7 709 16 1621 72 • Subsequent restenosis may require repeat dilatation of the arterial segment containing
Events through 393 Days (All Subjects Registered Population) 3.0 12 6F (0.070"/1.8 mm) 7 709 16 1621 73 the scaffold. The long-term outcome following repeat dilatation of endothelialized
8.4.3 Summary of Clinical Results out to 2 years (Interim Data Cutoff) scaffolds is unknown at present.
Table 6: ABSORB EXTEND Subject Counts of Ischemia-driven 3.0 18 6F (0.070"/1.8 mm) 7 709 16 1621 73 6.2 Scaffold Placement – Precautions
Adverse Events through 758 Days (250 Subjects Registered 3.0 23 6F (0.070"/1.8 mm) 7 709 16 1621 73 • Do not prepare or preinflate the delivery system prior to scaffold deployment, other
8.5 Propensity Score APdojpuusltaetdio Ann)alysis of Absorb BVS System and XIENCE V 3.0 28 6F (0.070"/1.8 mm) 7 709 16 1621 73 Sthyasnt eams dPirreecptaerda.t iUosne. balloon purging technique described in section 10.4.4 Delivery
8.5.1 6-month Propensity Analysis 3.5 12 6F (0.070"/1.8 mm) 6 608 16 1621 73 • Size the reference target lesion diameter appropriately to avoid overexpanding the
TTaabbllee 78:: MAnAgCioEg arat p6h iMc oOnuthtcso fmroems atht e6 IMPSoWnt-hAsd fjruosmte dth De aItPaSW-Adjusted 3.5 18 6F (0.070"/1.8 mm) 6 608 16 1621 73 ssccaaffffoolldd tdoa menasguer.e adequate scaffold apposition. This will reduce the risk of causing
8.5.2 1-year ProDpaetnasity Analysis 33..55 2238 66FF ((00..007700""//11..88 mmmm)) 66 660088 1166 11662211 7734 • Wonh tehne indterloivdeurcyi nsgy sttheem d. eTlihviesr ym sayys tceamus ien tdoi sthloed vgeesmseenl,t doof nthoet sincdauffcoel dn efrgoamti vteh ep rbeaslslouorne .
Table 9: Clinical Outcomes at 1 Year from the IPSW-Adjusted Cohorts
8.5.3 2-year Propensity Analysis * See individual manufacturer specifications for (F) equivalent. • Do not torque the catheter more than one (1) full turn.
Table 10: CColinhiocratls Outcomes at 2 Years from the IPSW-Adjusted ** ADsespuloryem fuelnl td epprelosysmureenst sohfo tuhled sbcea fbfaoslde d(s oene lseesciotino nc h1a0r.a6c tDeeripstliocysm.ent Procedure). • Utos ce rcoasus tiao nle swiohne nm aadyv alenacdin tgo tshcea Affobsldo rdba mGTa1g eB oVrS d aisclroodsgse tmhee nlet.sion. Multiple attempts
8.6 88A..B66S..12O RBSS ItuIu mRdCym TDareys iogfn Clinical Outcome Data • ABthV enS ot enSm-ysspteteerrmialet u htreaems i npbdeeirecanatu toirnerc llmoucdoaentdeit dow rt ihtfhor ort uhthgee hp strhohedip uwpciintn.g dB oaewnfod ri nes ttuohsreae g boeaf c otkhf itoshf e pt hrAoebd psuorcortdb, u cGchTte 1cb ko x. • Itinmot epthrlaveen sntictniaogfn fao ( lsCdc AaaBnffGdo ,lm df uamrytah cyea rlu edsaielda tataoct uiodtnies, s cpelolcastciuoernme oeofnf ttt hhoeef vavedessdssiteeioll ,nd raiesl qtsaucl iraaifnnfgod lda/ sdo,dr oitpiror oonxtahilme ra)l.
Table 11: Clinical Outcome through 1 Year Consult product carton or carton insert for indicator legend. • Do not expand the scaffold if it is not properly positioned in the vessel. (See section
91.00. 0 8911PCA..00L71T..I 12NI E ICNBIIMITnnAe dsaNSnpitv eEeeUirfLdciiStaEut iEloCaos fln TIi RNzt IhaOPeFetrqNOii oouA RnAribrM NetosodADfo TUrT bTIrsOe ReBaNEitomArTeeMsnotErNbTable Scaffold Technology 2SiTacsshh.t 0e oaisi rnrpi atlseeecninnt e–gdor leirTesH d-hdtO iuiacassWmsf etd e a ieSnrdg vteUterihvocdPeidec.P ufeiLisc rIcs eEEatd D-nu bunsenoaadtgm eebr. e rc Carodehniuaadsntiiegtoideon sn-o ssnitn e o armfin lrioezectephhdeea.ar n Ntpeiocadant ilu-e,p snpyethr,, o yacgssleei caniatn ilci,is n.a gDnn,oo dat nn/d odoe tsr / u icgoshnre eer mdiefs ittcthoeae rpli lpeizarafcotkiroamng e •• WptrA6herv.ed4ihoo u einrSdcn etc e oestasr dcefs fatactohfotaelfid onf cfc lgord/h o limdSansinysgnucs glttateh iepct ehomlre eofp sdlRrpeosaers xommaiioxmnainomygasv il aasn wsllig dcli– eteaoh s fPribfin oordr enlatidhsc.n leaioScn udhcs tpgaeaiolmifsanfn ocge≥sle d. tv)m2hiene.esg0 ns p /mter olso,m xtfse im tcnhinataeif nl fd dgosii alcsdinmat a /ft eflh sotsitelscedr na..oftr fdothelder /do ibssvtteaianl ttle,e sas niodn
10.3 Vessel and Lesion Selection may compromise the integrity of the design and / or materials, leading to contamination • The inflated balloon diameter of the system used to deploy the scaffold should
Table 12: Target Vessel Diameter Ranges and Absorb GT1 BVS Diameter to be due to narrow gaps and / or spaces and diminished safety and / or performance of the approximate the diameter of the vessel. To ensure full expansion of the scaffold, the
Used (Quantitative Imaging) device. Absence of original labeling may lead to misuse and eliminate traceability. Absence balloon should be inflated to a minimum of nominal pressure.
10.4 Preparation of original packaging may lead to device damage, loss of sterility, and risk of injury to the • Do not exceed the Rated Burst Pressure (RBP) as indicated on the product label.
10.4.1 Packaging Removal patient and / or user. Monitor balloon pressures during inflation. Use of pressures higher than specified on
10.4.2 Dual Layer Sheath Removal Contents – One (1) Absorb GT1 Bioresorbable Vascular Scaffold System; one (1) the product label may result in a ruptured balloon, with possible intimal damage and
10.4.3 Guide Wire Lumen Flush temperature monitor dissection.
10.4.4 Delivery System Preparation Storage – Store at or below 25°C (77°F); excursions permitted to 30°C (86°F). • Scaffold retrieval methods (use of additional wires, snares, and / or forceps) may
10.5 Delivery Procedure result in additional trauma to the coronary vasculature and / or the vascular access
10.6 Deployment Procedure 3.0 INDICATIONS site. Complications may include bleeding, hematoma, or pseudoaneurysm.
10.7 Further Expansion of the Deployed Scaffold The Absorb GT1 BVS is a temporary scaffold indicated for improving coronary luminal • When multiple Absorb GT1 Bioresorbable Vascular Scaffolds and drug-eluting stents
10.8 Removal Procedure diameter that will eventually resorb and potentially facilitate normalization of vessel function are required, only Absorb GT1 Bioresorbable Vascular Scaffolds, Absorb Bioresorbable
11.0 TRADEMARKS itnre paatetide nletss iownit hle nisgcthhe smhiocu hlde abret dleissse atshea nd uthee t on odme innoalv osc naafftoivled icnogr olennagrtyh a(r8t emrym le, s1io2n ms.m T,h e Vwaitshc uoltahre rS cdaruffgo-ledlsu toinrg e vseteronltism ours c-eolautteindg s stetenntsts h masu snto bt eb euesne de.v Paolutaetnetdia la inndte srahcotuioldn
18 mm, 23 mm, 28 mm) with reference vessel diameters ≥ 2.0 mm and ≤ 3.8 mm. be avoided.
4.0 CONTRAINDICATIONS • The extent of the patient’s exposure to drug and polymer is directly related to the
The Absorb GT1 BVS System is contraindicated for use in: number of scaffolds implanted. A patient can receive up to a total scaffolding length
• Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated of 94 mm.
• Patients with a known hypersensitivity or contraindication to aspirin, both heparin • The safety and effectiveness of the Absorb GT1 BVS in patients with prior
and bivalirudin, clopidogrel, ticlopidine, prasugrel, and ticagrelor, everolimus, poly brachytherapy of the target lesion or the use of brachytherapy for treated site
(L-lactide), poly (D,L-lactide), or platinum, or with contrast sensitivity, who cannot be restenosis in an Absorb GT1 BVS have not been established. Both vascular
adequately premedicated brachytherapy and the Absorb GT1 BVS alter arterial remodeling. The combination
between these two treatments has not been established.
5.0 WARNINGS • Postdilatation with a noncompliant balloon is recommended following instructions in
• The potential long-term benefits of the Absorb coronary device in comparison to the section 10.7 Further Expansion of the Deployed Scaffold, as long as the postdilated
available therapies are to be confirmed in additional clinical studies. segment is within the allowable expansion limits of the scaffold.
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• An unexpanded scaffold may be retracted into the guiding catheter one time only. An For more detailed drug interaction information, please reference the most recent everolimus 8.0 CLINICAL INVESTIGATIONS OF ABSORB BVS SYSTEM
unexpanded scaffold should not be reintroduced into the artery once it has been pulled drug label 1, 2, 3 ,4, 5. The Absorb GT1 BVS is based on the predicate device, Absorb BVS. The clinical
• bodSBRiafVhes cotmSlhoku edo Slid vgnyg aetsruoldeti eds –tdmhii nsuPe,tgr arig pennculcgceaia daetrhu sienbetetigetr oear ncrefce sfatseli.ttohhr naoett out beal datrn.h c yneSk o utsiitnbm tebtsoepee s qtdph uupeeerrr ionfgnotvug rimmid dreeoiendmvdg e,io n mcav assaet elnh tchote tefiti neo ts rhn.ace n6a duf.f4 noo dlSudect p matlhofafryooyel uddbg eh/A dbStahsymeos rtdaebgim sGet adTl 1 oe rn d 6Tonuonrh.8 ktins nbu operswreoinnnd g suaP tcwtur tetd oh(gimtienhsde aet.n ni mAW cobyehrs. i oilner bmth GeeTrne1 i nisBt eVnnSod iScnoygsn tttoeram fina)dt haicenard tc ieohvnile,d rtroheleinm .r uiEssfkf eshc aatvsne do nnroe ttph rbeoe ddeuencv tteeivlsoetp eeidnf fgein cf etpstru easgr enh aanvte iTdAAonrthbbvhuesseeg oosrA rrtdAibbbges banGGobtsiTTrooibt11tny t ,G s BsVp TcVoae1aSsurf mct fBldouiVnaillfdaneSf erde d rhn ResiatnlX isf sv rs sceotehtramecyefntf ioststoh ylan/des m s t8mAece.mba0a msfr fkwouooertledbdrilrsie ez,sB e oyapVssfneS ttdere hfxo omespnr casmlsyan a afesmifnndoiod eltdon hcp n,ed or b etirsnhaosccecinagi kpaAfnbflrbe oyoa sl ndosdoe fird tl bahomet eplaBai evtAVtireeoabSrrntysi.ia o ocls,nra yb stsa hcBtneaeVdtmfef Somr..s l dTa.T thhceeeor i aatlsin ga,s
• Imcenmo amteyhr epbg leereat neirncelyys e ecpvroeetevrnd ett rhoaeenfd dh ab codyuse tptpehitl eoao ylcb escadtliaul onwsudiiotta hnirmi dnf o potllhlfao encw tas.ir ncAeag.lf lf soacbldarf ufsopultdc ch pl otlahscauetr emthse emn Atu,b sast obbraebi l otGrueTta1 ti meBdpV alSas n ista n 77A..d01v erse eAOveDbnsVtesEr RovSbeEsde EArVvdeEvdeN riTsnSe t hEev eAnBtSsORB clinical trials that are related to the key clinical BpAeabrssfeoodrrbm o BannV tcShee. oTidfh eethnreetif coAarble s,n oacrtlbuin riGec Tao1lf t trBhiaVelS dA acbtasano frbober G ApTbr1esd osirccbtae fBdfoV tlSod abtoree t shsiemu mAilabmrs aotorrib zte hsdec iapnfe ftrohfloidsr, m seacntcioen o.f
Note: It is recommended that bailouts be done with a metallic everolimus-eluting stent outcomes of death, cardiac death, myocardial infarction (MI)(Q-wave and non-Q-wave), 8.1 ABSORB Clinical Trial
of appropriate size. target lesion revascularization (TLR) (by percutaneous coronary intervention [PCI] or The ABSORB clinical investigation is a prospective, single-arm, open-label, multicenter,
6.3 Use in Conjunction with Other Procedures coronary artery bypass graft), scaffold thrombosis, and ischemia-driven Major Adverse international clinical study to evaluate safety and performance of the Absorb BVS in coronary
• Waint hhceillirene icvcetaoslm streyila dplser evwpiciatehras u,t isothene oi nsf aecfioethtmye pra lmnexde lceehfsfaeioncnitcisva eml naaetsyhs ei rnhecacluvtoedm en yoth td ebe uevesicnee sofo f( rvdmairareiloclyut iose snmtaale bclihsahneidc al Cpevraeersndetiasnc tae Erdev ieinnn cst le(uMcdteiAodCn Ei n8) .s0(ec cCotmliionpnioc 7sa.ilt2 eI n Povofe tcseatnirgtdiaaiatli coA nddsve eaotrfhs ,eA M bEsIv,o eirsnbct shB.e VmSi aS-ydsrtiveemn. TALlRl o [tIhDe-rT aLdRv]e) rasree afPoraltlceoirfwiieces dr. e Tbghyioe an sp.tpurdoyx iwmaaste dlye s1i0g1ne pda ttoie netnsr o(Cll ouhpo trot B3)0 apta 1ti2e nctlsin (iCcaolh soirtet sA )in a Et u4r ocplien icaanld s Aitseisa
atherectomy catheters, rotational atherectomy catheters) or laser angioplasty catheters 7.2 Potential Adverse Events Eligible Criteria: Patients at least 18 years of age with evidence of angina, myocardial
in conjunction with Absorb GT1 BVS implantation. Adverse events that may be associated with PCI, treatment procedures, and the use of a ischemia, or a positive functional test; female patients with childbearing potential with
6.4 Scaffold / System Removal – Precautions coronary scaffold in native coronary arteries include the following, but are not limited to: ac onnetgraactievpet iporne gdnuarinncgy p taerstti cwipitahtiionn 7 i nd athyiss pcrliionric taol tihnev eisntdigeaxt iporno;c aenddu rpea atinedn tesf fwechtoiv sei gned
• Scaffold delivery system removal prior to scaffold deployment • Abrupt closure • Infection and pain an informed consent prior to enrollment. Angiographic inclusion criteria included: Nominal
If removal of a scaffold system is required prior to deployment, ensure that the guide • Access site complications • Injury to the coronary artery vessel diameter of 3.0 mm; lesion length ≤ 8 mm by visual estimation extended to ≤ 14 mm
catheter is coaxially positioned relative to the scaffold delivery system and cautiously • Allergic reaction or hypersensitivity • Ischemia, myocardial for the 3.0 x 18 mm scaffold; % diameter stenosis (%DS) of ≥ 50% and < 100%; TIMI flow
withdraw the scaffold delivery system into the guiding catheter. Should unusual to contrast agent or polymer poly • Myocardial infarction of ≥ 1. Key angiographic exclusion criteria included: aorto-ostial location; left main location
resistance be felt at any time when withdrawing the scaffold into the guide catheter, (L-lactide) (PLLA), polymer poly (D,L- • Nausea and vomiting within 2 mm of the origin of the LAD or LCX; excessive tortuosity proximal to or within the
• tuWhneiit ths.d cTraahfwifsoa lsdl h odofe utlhlidve e brseyc adsfyofsontlede m udn eadlinevdre rdtyhi rese ycgstu tveidimseu ca/ alpiztohasetittodenirl aswthaiotthiou lnfdl u bboaerlo lorseocmno pofryvo.emd tahse ad espinlogylee d • laAannctetiipudlreay)tse (mlePt D dLrLuAg)s, oarn dc odnrturgas rte aagcetinotn s to •• PPaerlpicitaartdioianls effusion ltseaisdrgieoe nbt ;rv aeenxsctsrhee.ml ceo natnaginuilnagtio tnh r(o≥m 9b0u°s);; ohtehaevr yc lcinailccaiflilcya stiiognn;i friceasntet nleostiico nfrso min tphree vtiaorugse ti nvteesrsveenl toior n;
s1c. affDboaeldlflloaoten sth we ibll atlalokoe nm boyr ep utilmlineg ( unpeg taot i3ve0 osne ctohne dins)fl atoti odne fdlaetvei cteh.a nL asrmgearl laenr da nlodn ger •• AvAerrrntehtrryiiatchlu mplaeirar sfo, riantciolund ing atrial and •• PPineejurriircpyah)redraitli sischemia (due to vascular Toorffe Aaapbtpmsrooerpnbrt i BaSVtterS al etwenaggsyth :d ,P iasrnaelddlo iliwaf tneaodtit.o anAv noayfi labthbaeliel ot,a uartg CmeYtu PlseHts EiboRen ® dw osanirseo mlwimaitunhsd o-aevtoleurrtlyian. pgPp lsiantngenn aet;d X boIaEviNleoCrulaEtp wVp iitnshtge nt
shorter balloons. Confirm balloon deflation under fluoroscopy. • Arterial rupture • Peripheral nerve injury Absorb BVS was not permitted. Postdilatation was performed at operator discretion, but only
2. Position the inflation device to “negative” or “neutral” pressure. • Arteriovenous fistula • Pulmonary edema using balloons sized to fit within the boundaries of the scaffold.
3. SMtaaibnitlaizien gguuiiddee cwaitrhee ptelar cpeomsietinotn a jcursots os ustcsiadfefo cldo rsoengamrye nots.tium and anchor in place. • Brelqeeudirien gtr acnosmfupsliicoant ions, which may •• PRseenuadl oinasnuefufircyiesnmcy / failure Alonatdipinlga tdeoleste R oefg cimlopeind:o Sgurebl jebcistsu lfnaotet o≥n 3c0h0ro mnicg aanntdip alastpeilreint m≥e 3d0ic0a tmiogn s6 htoad 7 t2o hroecuersiv ep raio r to
4. Gently remove the scaffold delivery system with slow and steady pressure. • Cardiac arrest • Restenosis of scaffolded segment the index procedure if possible, but no later than 1 hour after the procedure. All patients were
5N1.)o teTIsf:i,g dhuternin tgh ew irtohtdatrianwg ahl eomf othseta ctiact hvaeltveer. from the deployed scaffold, resistance is •• CCaarrddiiaacc, tpamulmpoonnaadrey, or renal failure •• SSanhtrdoo ckTkeIA / cerebrovascular accident rtcoelo qtpuhiiedr eosdgt artenold rbaeircsdeu iolvffae tc eaa ndretai cialoyta tfghouer l aact limionniicn aaimln sdui mtoet .h oAef lrl6 tp hmaetoriaenpntyhts sd wuanerirdne g ≥ tos 7c b5aef fm omlgda ioinmft aapisnlapenidrti anot indo an7i 5lay c mfcoogr r tdhine g
encountered, use the following steps to improve balloon rewrap: • Coronary artery spasm • Total occlusion of coronary artery length of the clinical investigation (5 years). Patients who developed sensitivity to clopidogrel
° Rtoe n-ienufltaratel. the balloon up to nominal pressure, deflate and change pressure •• CCoorroonnaarryy oorr ssccaaffffoolldd ethmrobmolbisomsi s •• UVanssctaublaler coor mstpalbiclea taionngsin, ain pcelucdtoinrgis entry bstisaunldfaatred whoesrep ittoa l bper ascwtiictceh.ed to ticlopidine hydrochloride at a dose in accordance with
° Repeat steps 1 through 5 above. • Death site, which may require vessel repair 8.2 ABSORB Cohort A
2) Arefsteisr tsauncccee bssef ufel ltw aitth adnrayw taiml oef wthhee bna wlloitohnd rfarwomin gth teh ed espclaofyfoeldd sdcealifvfeorldy, ssyhsoteumld any •• DDiissstaelc etimonb oolfi (thaier, ctiosrsounea,r yo ra trhterorymbotic) • Vveennttrriiccuullaarr faibrrrhilylathtiomni aasn, din vcelundtriincgu lar 8.2.1 Methodology and Current Status
or postdilatation balloon into the guide catheter, remove the entire system as a • Emergent or non-emergent surgery tachycardia A total of 30 patients in Cohort A were enrolled between March 7, 2006 and July 18, 2006 at
single unit. • Fever • Vessel dissection four clinical sites in Europe and New Zealand.
• Failure to follow these steps and / or applying excessive force to the delivery system • Hypotension / hypertension The ABSORB Cohort A Trial implanted the Absorb Cohort A BVS in patients with a single
can potentially result in loss or damage to the scaffold and / or delivery system de novo native coronary artery lesion. Enrollment started with the 3.0 x 12 mm size. The
components. Adverse events associated with daily oral administration of everolimus in doses varying 3.0 x 18 mm size became available later during enrollment and was used in only two
• If it is necessary to retain guide wire position for subsequent artery / lesion access, from 1.5 mg to 10 mg daily can be found in the Summary of Product Characteristics (SPC) patients.
leave the guide wire in place and remove all other system components. and labels for the drug 1,2,3,4,5. The risks described below include the anticipated adverse Clinical follow-up through 30 days, 180 days, 270 days, 1 year, 18 months, 2 years, 3 years,
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• Antiplatelet therapy should be administered post-procedure (see section 9.1 • Abdominal pain • Laboratory test alterations
Individualization of Treatment). • Anemia (elevations of serum creatinine, 8.2.2 Clinical Outcome at 5 Years
6.6 MRI Statement • Angioedema proteinuria, hypokalemia; At 5 years, the ischemia-driven MACE (defined as the composite endpoint of cardiac death,
The Absorb GT1 BVS is MR Safe. • Arterial thrombotic events hinycpluedrginlygc hemypiear, cdhyoslleipsitdeeromleiam ia and 2M.I2 o1r μIgD/-LT)L Rre)l artaetde twoa tsh e3 .t4re%a t(mTaenbtl eo f3 )a. nTohne-rfleo wwa-slim ointilnyg o sntee nnoosni-sQ (-QwCaAve d MiamI (epteear ks ttreonpoosnisin
6.7 Drug Interactions • Bleeding and coagulopathy (including hypertriglyceridemia; liver function tests 42%) of an Absorb BVS implanted 46 days earlier, in a patient who had one episode of
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administered orally along with cyclosporine (CsA). Hence, everolimus, when prescribed as • Constipation • Male infertility according to the protocol or the Academic Research Consortium (ARC) definitions.
atesctkohnvtnoue)eo n doriwsvnoireeiahnldisslmi e b simrnhieuattaoelste vidrw oresmainca cna aaltslon,iytoh itd ow nob bn ihuenwe, el ddeiminntnu h fba cdl upeyeeeee rvcginrsneiifdc votroeoeeirnfrmdln aigmC c etbYtotudoy P ws twdp3h.irletAiauht h4cpg o eostit sh thtteoehhen zearAty itmAabm alsb efefosfdoseroir;bcc r at bba Gbt otihGTsoteh1Tons 1 rsseBp y BttVpihsoVSataneS ttSmh aiwinynnicsca dt alyuea ssmdnsu.eud .bF b (lTsojobeehrcumcqeattur alea teldafr noedkrtur ir nenueg,golg ii dmt na iurnt ieeendtesr arartutracigioctc intotwie onoditnsfh in •••••• CDDDEHmoiiyeaasaubrbpdgrerhnahyteeceoasah-f eem taell ltitouxsicity •••• NNcNiOnyaeortacepunlrl sh-osuiersntoliacpfttieeooacrlrxa tiilnitcuoieoinut)yngs s (dpinins eecuaomsmeob)n initaist io(inn cwluitdhi ng CDHaeraiedtRhriaa,a cr%tc ehsical 6(N M =o0n 3th0s) Ta1b(N2le M =30o: 2nC9tlhi)ns†i ca(lN 2O =Yu0et ca2or9sm) †e a(tN3 5 =Y Y0e ea2ar9sr)s † (N4 =Y0e a2r9s) † (N5 =Y0e a2r9s) †
Everolimus, when prescribed as an oral medication, may interact with some drugs or • Hepatic artery thrombosis • Pain MI, % (n) 3.3 (1)* 3.4 (1)* 3.4 (1)* 3.4 (1)* 3.4 (1)* 3.4 (1)*
foods1,2,3,4,5 including, but not limited to: • Hepatic disorders (including hepatitis • Pancreatitis
• CYP3A4 / PgP inhibitors that may increase everolimus blood concentrations: and jaundice) • Pericardial effusion Q-Wave MI 0 0 0 0 0 0
°°°° IAMCmnaamltccifriuuuonnmliogd saecul hapaangpnterinebnesitolss t bai(clneost.c gc(k.ey,e .crfgsllu.o ,c(s ceop.lnoagarr.ii,ztn hoverel eor,ma kpyeactmoinci,l,o ennraiycztahorrldeoi,mp iitynracec,in od)ni latizaozleem k)e toconazole) ••• HsHIpnuryyfobepptcsoeettrrzaistooenenancn nse(s bi,iio ntatinovfce i ttcoeyttr ihitoaoenl ,rse fr,vua einpnrgaocamlliulm,yd vcuiniisrnga aldi ncoeftrrie vivceat itoenss •••• PPPPenlyerreuieuprxmhaiale oreanffli uao seiodnema IdsrcivheNWenmoa nTvi-aeLQ- RM-, I% 3.3 0(1)* 3.4 0(1)* 3.4 0(1)* 3.4 0(1)* 3.4 0(1)* 3.4 0(1)*
°° POrtohteera ssueb isnthainbciteosrs ( e(e.g.g.,. ,c nisealfpinriadvei,r ,m inedtioncalvoipr,r aammipdree,n barvoirm) ocriptine, cimetidine, wvirituhs -oapspsoorctuiantiesdti cn eppahthroopgaetnhsy. (PPoVlyAoNm),a •• RRaenshal failure by PCI 0 0 0 0 0 0
danazol) JC virus associated progressive • Upper respiratory tract infection by CABG 0 0 0 0 0 0
• CYP3A4 inducers that may decrease everolimus drug concentrations: multiple leukoencephalopathy (PML), • Urinary tract infection Ischemia-
° Antibiotics (e.g., rifampin, rifabutin) fatal infections and sepsis have been • Venous thromboembolism driven MACE
° Anticonvulsants (e.g., carbamazepine, phenobarbital, phenytoin) reported in patients treated with oral • Vomiting (cardiac
° Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, nevirapine) everolimus) • Wound healing complications (including death, MI or 3.3 (1)* 3.4 (1)* 3.4 (1)* 3.4 (1)* 3.4 (1)* 3.4 (1)*
° Glucocorticoids (e.g., dexamethasone, prednisone, prednisolone) • Kidney arterial and venous thrombosis wound infections and lymphocele) ischemia-
° HMGCoA reductase inhibitors (e.g., simvastatin, lovastatin) driven TLR),
° Other (e.g., St. John’s Wort) % (n)
Scaffold 0 0 0 0 0 0
thrombosis, %
1 Certican® UK label Nov 2014
2 Afinitor® EU authorization SPC Dec 2014 Notes:
3 Votubia® EU SPC Sept 2014 • Dtheen foomlloinwaitnogr eexvcenlutdse: sD esautbhj,e cMtsI, wanityh oreuvt afoscllouwla-riuzpa tdioanta ( TaLnRd , wThVoR ,d NidTnV’tR e)x.perience any of
4 Afinitor® US label Dec 2014 † One subject officially withdrew from the study after 6 months.
5 Zortress® US label Feb 2013 * This subject also underwent a TLR, not qualified as ID-TLR (DS = 42%) followed by
Refer to www.MHRA.gov.uk, www.ema.europa.eu, and www.fda.gov for the most recent post-procedural troponin elevation qualified as non-Q MI and died from his Hodgkin’s
versions of these SPC/labels. disease at 888 days post-procedure.
EL2105973 (2015-08-27)
Page 5 of 136
8.2.3 Angiographic, IVUS, and OCT Outcomes at 180 Days and 2 Years 8.3 ABSORB Cohort B XIENCE V in SPIRIT II. The IVUS data at 2 years (N = 33) revealed a finding unique to
Q18C0A- dreasyu dltast aw deerem coonlsletrcatteedd faronm a cbcaespetlainbele, pino-sstc-parfofocledd luartee, lo1s8s0 odfa 0ys.4, 3a n±d 02.3 y7e amrsm. Tphoes sibly 8.3.1 Methodology and Current Status A(6b.s4o2r bv eBrsVuSs, w7.h0i8c hm ism m2, epa <n s 0c.a0f0fo0ld1 )a. rTehai se nelnalragregmemenetn bt ewtwase egnr e6a tmero tnhtahns tahned o 2b syeeravresd
driven by bioactive remodeling or mechanical late recoil. From 180 days to 2 years, the Based upon the strong safety profile observed for the Absorb Cohort A BVS System in increase in neointimal hyperplasia and was accompanied by late increased mean lumen area
change in in-scaffold late loss was very low (0.48 ±0.28 mm). Cohort A, Cohort B of the ABSORB trial was initiated on March 19, 2009 to evaluate the (6.36 versus 6.85 mm2, p = 0.0105). IVUS findings were reported with comparative paired
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by grey-scale IVUS was the increase in minimal luminal area and average luminal area / Enrollment of 101 patients (45 patients in Group 1 with imaging follow-up at 180 days to 8.24 mm2 (p = 0.0155) from post-procedure to 2 years indicating loss of mechanical
volume together with a significant decrease in plaque area / volume between 6 months and and 2 years, and 56 patients in Group 2 with imaging follow-up at 1 year and 3 years) in integrity of the scaffold and potential expansion of the vessel. Scaffold strut coverage by
2 years. Cohort B was completed on November 6, 2009. Currently, clinical data are available for neointima was near completed at 6 months (98%) and 2 years (99%).
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afPinoprdleploiccawlarinet-einucstpa stl( hta3reun4rtae.s5l y i%dsse i nsrceo rdde ciuaroescrcetritdoely lnaf rctooioovmmne r4pb ta0ewrt3wion a egyte epbnara retssh-e)ee,lx ipnaprlellea wtsnoete an3ltlci 6oce8no o vaOret C ra1eTb8d s 0teao nn dpcdaoe yas sopt -fape nOoxdspC elTtado-n v tt2ioas6t iitb4ohl neea thvf etieshastetosu el2roel- gsywy ea allr. T8Tra.i3bal.l 2e( 1 40 1sh Csoluwibnsjie cccatlisln )Oi.c uatl cooumtceosm feosr tFhruolul gCho h4 oyreta Brs for all subjects in the ABSORB Cohort B peaanrn e<l aainr g0coer.f0e m1a04se0.en14 t)i3 n.is ±O noCe2foT .pi6 nar4etri smtmiucalumtlsl aa2 rara etit na 31t e ( y0ryee.e0saatr8r s b v±e(sNc0. a .1=u14s3 .e1 5m 88th)m ±ea2 lv 2saeo.t6s 1sr7ee yvml eeamaarlree2 a vda s wts. 3ca0 as.y2f efp8oar lerd±ss ,ee0 rpn.v4l ae=1rdg m0(eam.m4vee02 rn7aat)gt bed3e e vtysweepseaisteresen ,l
(apparent struts) and the presence or absence of polylactide polymer in the vessel. Hence, Table 4: Hierarchical Clinical Outcomes for Cohort B (ITT Population) 1 and 3 years (mean scaffold area of 7.51 ±0.95 mm2 at 1 year vs. 8.64 ±2.15 mm2 at 3
visual OCT features (apparent struts) are not always indicative of lack of resorption, but years, p = 0.0008). Lumen area remained relatively constant (6.01 ±1.29 mm2 at 1 year
absence of the apparent struts by OCT confirms resorption. The lumen shape was regular 30 Days 6 Months9 Months 1 Year 2 Years 3 Years 4 Years vs. 6.09 ±1.67 mm2 at 3 years, p = 0.679). The vessel area was not measured because
wImitpho srtmanotolyt,h m, wineimll-adle alinneda mteeda bno lrudmerins ailn a arlel ac adseecsre, aasnedd n soig innitfriaclaunmtliyn able ttiwsseueen wpoass t-opbrsoecrevdeudr.e N = 101 N = 101 N = 101N = 101N = 100*N = 100*N = 99** OreCmTa cinaendn osmt daellm aaltrhcoauteg hth teh eerxet ewrnaasl aenla sinticcr elaamsein ian. nOevoeinratilml, tahl eh ynpeeorinptlaimsiaal bheytpweerpelna s1i ay ear
and 180 days, but numerically enlarged between 180 days and 2 years. CDaeradthia, c% 0 0 0 0 0 0 0 ayenadr s3, ype <ars 0 (.m00e0a1n) n.eointimal area of 1.41 ±0.68 mm2 at 1 year vs. 2.35 ±0.68 mm2 at 3
8.2.4 Vasomotor Function Results at 2 Years 8.3.4 Discussion
Vasomotor function proximal, within, and distal to the treated (scaffolded) segments MI, % (n) 2.0 (2) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) A total of 101 patients were enrolled with clinical data available out to 4 years for the full
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doenp leoncdael nptr avcatsicoea.ctive agent acetylcholine (Ovisot, Daiichi-Sankyo, Tokyo, Japan), depending NWoanv-eQ M-I 2.0 (2) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) BsuVcSc eSsyss)t eamnd h saasf edteym uopn tsotr a3t eyde aarcsu ateft esru icmcpeslasn t(a9t8io%n .p Arot c4e ydeuarers s, uthcec eMssA CaEnd r a1te0 0r%em daeinveicde
In the methergine group (N = 7), significant vasoconstriction was observed in proximal and low at 3.4% and 10.1% in the ABSORB Cohort A and Cohort B groups, respectively.
scaffolded segments (Figure 1). In the acetylcholine group (N = 9), although the overall Ischemia- Furthermore, there were no cases of cardiac death or scaffold thrombosis in either cohort.
change in vessel dimension was not statistically significant, vasodilatation was observed driven TLR, 0 2.0 (2) 2.0 (2) 4.0 (4) 6.0 (6) 7.0 (7) 7.0 (7) Based on these results, the performance and safety continue to be established in the Cohort
in five patients. Nitrates induced a significant vasodilatation in the scaffolded and distal % (n) A and Cohort B studies.
segments, relative to baseline (pre-acetylcholine) at 2 years. These results suggest the by PCI 0 2.0 (2) 2.0 (2) 4.0 (4) 6.0 (6) 7.0 (7) 7.0 (7) Imaging of Cohort B indicated that angiographic late loss appears to stabilize between 1 and
potential restoration of vasomotor function in the treated segments when the Absorb Cohort 3 years. In Group B1 and Group B2, IVUS results indicate a late expansion of scaffold and
A BVS had resorbed. Further data on vascular responses will be collected from ongoing by CABG 0 0 0 0 0 0 0 lumen dimensions between 6 months and 2 years, and between 1 and 3 years, respectively,
clinical trials. which was consistent with the scaffold expansion observed by OCT. These results suggest
Paired comparisons between the different time points were done by a Wilcoxon’s signed rank Ischemia- scaffold bioresorption accompanied by a loss of structural integrity. This phenomenon is
test for continuous variables. driven MACE, unique to bioresorbable vascular scaffolds and is in contrast with serial IVUS imaging of
Figure 1: Results of Acetylcholine and Methergine Testing in Proximal, Scaffolded, and (dceaartdhi,a Mc I or 2.0 (2) 5.0 (5) 5.0 (5) 6.9 (7) 9.0 (9) 10.0 (10) 10.1 (10) Pmaetiteanllitcs DwEilSl b, ew fhoelrloew laetde tlhurmoueng he x5p yaenasrios.n has not been observed1. Follow-up is ongoing.
Distal Segments ischemia-
driven TLR), 8.4 ABSORB EXTEND
% (n) The primary objective of the ABSORB EXTEND study is to continue the assessment of the
Scaffold safety and performance of the Absorb BVS System in a larger patient population across more
thrombosis 0 0 0 0 0 0 0 global geographies. This trial collects clinical data without the effects of extensive imaging.
(%) Treated lesions are slightly more complex than those included in prior ABSORB trials. Longer
lesions are permitted by using planned overlap of the Absorb BVS, or by using longer Absorb
Data are % (number of patients); MACE = (cardiac death, MI or Ischemia-driven TLR) BVS sizes as they become available. The following section summarizes the study design and
* One subject was lost to follow-up after the 2-year visit. interim clinical outcomes from the ABSORB EXTEND study.
** One patient was terminated early having had no safety events, and therefore removed 8.4.1 Methodology and Current Status
from the numerator and denominator in the 4 Years column. ABSORB EXTEND is a prospective, single-arm, open-label clinical study that is planned to
register up to 1,000 subjects at up to 100 global sites. Each subject is to receive treatment
For the full Cohort B (101 patients), there were three non-Q-wave MIs that occurred, two in up to a maximum of two de novo native coronary lesions with each lesion in a different
during hospitalization, and one at 43-day post-procedure. Seven ID-TLR by PCI have been epicardial vessel. Subjects having target lesion length ≤ 28 mm and reference vessel sizes
reported through 4 years. The overall MACE rate at 4 years was 10.1% and there have been that are suitable to be treated with an Absorb BVS can be registered in ABSORB EXTEND.
no cases of cardiac death or scaffold thrombosis per protocol or per ARC definitions. The 3.0 x 18 mm Absorb BVS has been available from the start of the trial registration. The
The 4-year full Cohort B (101 patients) outcomes are numerically higher than the Cohort 3.0 x 28 mm, 2.5 x 18 mm, 2.5 x 28 mm, 3.5 x 12 mm, 3.5 x 18 mm, and 3.5 x 28 mm
A (30 patients) outcomes at 4 years. The clinical outcomes at 48 months reveal a MACE have been incorporated into the trial as they became available. Enrollment was completed
rate of 3.4% and 10.1% in the ABSORB Cohort A and full Cohort B groups, respectively. in ABSORB EXTEND with 812 patients in October 2013. Patients will be followed for up to
Furthermore, there were no cases of cardiac death or scaffold thrombosis in either group. 3 years.
The Cohort B clinical results continue to support the performance and safety established in
the Cohort A investigation. 8.4.2 Summary of Clinical Results out to 1 year (Interim Data Cutoff)
Of the total of 605 patients registered in ABSORB EXTEND as of December 3, 2012, 37-day
8.3.3 Angiographic, IVUS, and OCT Outcomes at 180 Days, 1, 2 and 3 Years (30 days ±7-day window), 194-day (180 days ±14-day window) and 393-day (365 days
The 180-day angiographic results from Cohort B Group 1 (Cohort B1) demonstrated a late ±28-day window) clinical follow-up data were available for 591, 537, and 450 subjects,
loss of 0.19 mm (N = 42) which compares well to the 0.10 mm late loss (N = 23) of respectively (Table 5). The composite endpoints are presented using the protocol definitions
the 3.0 x 18 mm XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) for MI. The component endpoints are based on non-hierarchical counts unless otherwise
observed in the SPIRIT FIRST First-In-Man trial, and show favorable improvement from the noted.
8.2.5 Discussion 0.43 mm late loss (N = 26) from Cohort A. Table 5: ABSORB EXTEND Subject Counts of Ischemia-driven Adverse Events through
In this prospective, single-group, open-label study, the Absorb BVS demonstrated acute At 180 days, the IVUS results from Cohort B1 showed limited intrascaffold neointimal 393 Days (All Subjects Registered Population)
s9pthuo4rcso%ctu- egdpshersov 5 ciac enyedde usa rsureasc f caewnetiysgth siof; o ngalolrona wdpc haisnricudg ci aatchnceed sd sfIeiVfrausUtlth S rs3e ,a0v nn adoasal cyIyDussle- aTasrLfi.zt ReTarsht i oeiom nre p xoslcacf enatlhtflafeeotn iltotda n crt:glh ien1roti0c ml0ae%lsb iso opasnfri esoet cyvreei dpdceeuonrrrsedt i efssrdtous,mc ac ne ds s; Sha(VryPeOpIaRe orIwTpf a l5aFs.sI 3Ri0a%S.,0T t[8 hN( eVm =Ovmo ol22uf 5 (m8N] .e 0a= n%odb 4 [sNN0trI) Hu=. c Tat ih2roee1nas] e (oaV frnO e0ds) . u2Nwl9tIaHs sm c a1omre.m22a %p [oNa f(r eN=0 .f=5 a26v 5o 4m]r0)a.m)b Ala2ys n [ wdNo ib tt=hhse e X r2nvIE1eeN]od)iC nianEtni mCdV oa wElh EihotChyrt pS CAeSor, p hi nloa rsti aA Events AB0S( ON–R =3B7 E5DX9aT1yE)sN D AB0S (–ON R 1=B9 4 E5 XD3T7aEy)Ns D AB0S (–ON R 3=B9 3 E4 XD5T0aEy)Ns D
only one non-Q-wave MI by 5 years. Despite the discontinuation of thienopyridine drugs, no the 6-month IVUS results showed a significant reduction in the average lumen area Hierarchical MACE 2.4% (14/591) 3.0% (16/537) 4.2% (19/450)
sevciadfefonltd b tyh r5o myebaorssi.s occurred, and no additional ischemia-driven target lesion restenosis was (p6 =.60 0 ±.0014.282) . mThme2 v[eNs s=el 3a7re]a a rfetemr apirnoecde dcuorme pvasr.a b6l.e3 7b e±tw1e.e1n2 bmamse2l in[Ne a=n d3 178] 0a-td 1a8y0 f-odllaoyw, - up Hierarchical TVF 2.4% (14/591) 3.4% (18/537) 4.7% (21/450)
The use of multiple imaging modalities yielded several important findings. At 180 days, (o1f 4s.i2g2n if±ic3a.n7t 5e xmpman2s [ivNe =or 3c7o]n svtsr.i c1ti4v.e4 9re m±o3d.6e7lin mg.m2 [N = 37]) demonstrating the absence Non-Hierarchical Counts
athna na cpcreepvtiaobulsel ya nogbisoegrrvaepdh iicn iXnI-EsNcCafEfo Vld a lta 6te mloosnst hosf 0(S.4P3IR mITm F IwRaSsT )s, eaennd; tphoiss swibalsy hdirgivheenr by The 1-year angiographic results from Cohort B Group 2 (Cohort B2) demonstrated a late Cardiac Death 0.2% (1/591) 0.2% (1/537) 0.2% (1/450)
bioactive remodeling or mechanical late recoil. The IVUS results showed low intrascaffold loss of 0.27 mm (N = 56) which compares well to the 0.23 mm late loss (N = 22) of the MI 2.4% (14/591) 2.8% (15/537) 2.9% (13/450)
nneeooiinnttiimmaall hvoylpuemrpel.a sTihai:s 5 c.3o2nf%ir mine-ds caa fpfoolsdit ivvoel udmrueg oebffsetcrut cinti oinnh, i4b.i0tin9g m rems3t einn-ossciasf.f old 3C.o0h ox r1t 8B 2m (mN X=IE 5N4C)E s Vh oowbesder lvimedi teind tihnetr aSsPcIRafIfTo lFdI RnSeTo intrtiiaml. aAl th 1yp yeeraprl,a tshiae, ItVhUeS p erercseunlttsa gfreo m QMI 0.7% (4/591) 0.6% (3/537) 0.9% (4/450)
At 2 years, angiographic results showed an acceptable 2-year in-scaffold late loss of oanf din 0-s.0c9af fmolmd 2a,r ereas opbecsttrivuecltyio).n O avnedr ttihme en tehoeinreti mwaals hay psetarptislatsiciaa llayr esaig wniefircea mnt inbiumt anlo (t1 .43% NQMI 1.7% (10/591) 2.2% (12/537) 2.0% (9/450)
0.48 mm with minimal changes from 6 months (0.43 mm) to 2 years. By contrast, both clinically relevant increase in total plaque area with a concomitant increase in vessel area. ID-TLR 0.3% (2/591) 0.6% (3/537) 1.8% (8/450)
tThhee IVcoUnSt raansdtin OgC fTin ddiantgas s ihno lwateed l ulamtee nlu mdiminaeln esniolanragl ecmhaenngt efrso mbe t6w meeonn tahnsg itoog 2ra ypehayr sa.n d tFou r1th yeermaro (r6e.,3 a3v e±ra1g.e1 7lu mmmen2 )a. rBeay rOeCmTa, itnheedre s wtaabsle n foro smig pnoifsicta-pnrto ccheadnugree (in6 .t3h1e ±me0a.9n5 a mndm 2) ID-non-TL TVR 0.0% (0/591) 0.6% (3/537) 0.9% (4/450)
intracoronary imaging await confirmation in future clinical studies. minimum scaffold area between post-procedure and 1 year (N = 21). There was a reduction Scaffold Thrombosis 0 – 30 days 0 – 194 days 0 – 393 days
At 2 years, reduction in molecular weight and mass had occurred to such an extent in minimal lumen area and mean luminal area decreased significantly as a result of mean
that echogenicity was lost and that struts were no longer recognizable by intravascular neointimal area growth (1.34 ±0.67 mm2) but was not clinically significant. The lumen Definite 0.3% (2/591) 0.4% (2/536) 0.7% (3/449)
ultrasound, leaving behind few IVUS-visible features. OCT-visible features related to area stenosis increase was statistically significant from 20.2% post-procedure to 26.9% at Probable 0.2% (1/591) 0.2% (1/536) 0.2% (1/449)
vessel healing were present in some patients. In these patients, OCT showed an optically 1 year but not clinically relevant. These data further supported that there was no reduction
homogeneous vessel wall structure that, taken together with the potential restoration of in scaffold area. 1 Claessen BE, Beijk MA, Legrand V, Ruzyllo W, Manari A, Varenne O, Suttorp MJ, Tijssen
vessel movement, suggests healing of the artery. Imaging results at 2 years from Cohort B Group 1 (Cohort B1) demonstrated in-scaffold JG, Miquel-Hebert K, Veldhof S, Henriques JP, Serruys PW, Piek JJ. Two-year clinical,
angiographic late loss of 0.27 mm (N = 38), which matches the late loss observed at angiographic, and intravascular ultrasound follow-up of the XIENCE V everolimus-eluting
1 year for Cohort B Group B2 but is lower than the 0.33 mm (N = 83) reported from stent in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II
trial. Circ Cardiovasc Interv. 2009 Aug;2(4):339-47.
EL2105973 (2015-08-27)
Page 6 of 136
data were more balanced in baseline patient demographics and angiographic characteristics
Events AB0S O–R 3B7 EDXaTyEsN D AB0S –O R1B9 4E XDTaEyNs D AB0S –O R3B9 3E XDTaEyNs D bcoetmwpeaerna bbloet.h T ahrem asd.j uAst te6d m 6o-nmthosn,t hth MeiAr CclEin riactael so wutecroem 2e.0s 1a%nd ( 0a.n7g/i3o4g)r aapnhdi c5 r.2es7u%lt s( 3w.5e/r6e6 ), Catl i2n icyeala rOsutcomes A(bNs o=rb 1 B78V)S (XNI E=N C2E9 3V) p-value
Definite / Probable 0(.5N% = ( 35/9519)1) 0(.6N% = ( 35/3573)6) 0(.9N% = ( 44/5404)9) rweisthp eAcbtisvoerlyb, BfoVrS t,h ea Atrbesnodr bth aBtV iSs canodn sXisIEteNnCt Ew Vith a rthmes r e(Tsaubltlse f7ro)m w itthhe a u lnoawdejur sMteAdC gEr ooubpsse.rved T[9V5F% CI] [3.95%7,. 31%2.17%] [8.761%2, .136%.60%] 0.09
Note: Subjects are only counted once for each type of event in each time period. Table 7: MACE at 6 Months from the IPSW-Adjusted Data Definite / Probable
The ND37eo-ctede:am yAb lMle trAa 3Cb,lE e2 ae0nn1dt2r i.Te Vs Fw reartees c oaflc 2u.l4a%te dw beares eddr ivoenn t hbey dMaIt ae vfreonmts d(1a0ta NcQutM-oI faf ndda t3e QofM I C6 lMiniocnatlh Osutcomes at Absor(bN B =VS 3 4S)ystem X(NIE =NC 6E6 V) p-value ST[9hc5rao%ffmo ClbdIo] /s iSst e nt [0.010%.,6 3%.09%] [0.371%.,4 3%.46%] 0.65
hAiReCra rdcehfiicnaitliloyn) .t hTahte w oevreer aallll nroelna-theide rtaor cthheic taal rMgeI t rvaetes saet l.3 7T hdearyes w waass o 2n.e4 c%a r(d1i4a/c5 d9e1a) th(1 p0e Nr QMI M[9A5C%E C I] [02.0.001%%, 6(0.7.73)%] [0.50.02%7%, 1 (03..656)%] 0.44 Note: Components (cardiac death, MI and ID-TLR) are presented as non-hierarchical.
and 4 QMI). Discussion: The comparability of Absorb BVS to XIENCE V demonstrated with in-scaffold / stent
Taannhdde 12M AcIDaC-rENd ioraanct- eTd Lien aTctrVhe.Ra T shheiede r TatoVrc F3h .ri0ca%atell yaa]tt) 6.6 O mmnooen nptthhassti, e wanttat srwi b3huo.t4 ed%di e m(d1 o8as/t 5tdly3a 7yto [1 1t0h c8ea 1wrd5ai ashc iae ddraejuracdthhici,ca 1ate5l d MM I I, TAs(pihbg es=n oi6f ri-0cbm.a 6Bno8Vtn )Sdt.h iSfS fiienymrs-editlneaemcrvleiy c ,v iensd .ilfoa f0tuee.tr1 cel2oon smc±see s0isn . i2 nbt6h et ethmw eIPe mienS n-Wfdo ter-h avetdhi cjAeue bs X%stIeEo ddNrb iCaa rBmEmV eVsSt e EwSrE yasCssteSt e0nSm.o,1 s r4aies np±, drien 0ts-h.se1een8 gtX immnIEgmeN naC t f Enola orV tnte h-E elEo CssS,S lmbaetaetwi nloetaesinsn eaAdtb 6tsh ormorbuo gnBhtVh S2s -(ayCneodah rXso IrEptN oBsC toE in mVlyp )bl,aa ansnteaddt i oconlnin. piTcrhaoelp oecunotslclietoycm taivenesa ldayats t6eas mc.oonnftihrms,s a tnhde 1c oymeapra wraebrieli ty
as cardiac death per the ARC definition for cardiac death (0.2% at 194 days, 1/537). No and in-segment % diameter stenosis were not significant between the two devices in this 8.6 ABSORB II RCT
Absorb BVS was implanted in the target lesion in this patient because there was difficulty propensity score adjusted analysis (Table 8).
in crossing the lesion with Absorb BVS. A metallic everolimus-eluting stent was implanted 8.6.1 Study Design
instead. Over the same period, the ID-TLR rate was 0.6% (3/537) due to the occurrence of Table 8: Angiographic Outcomes at 6 Months from the IPSW-Adjusted Data The ABSORB II trial is a post-approval, randomized (Absorb BVS vs. XIENCE, 2:1), actively
t(Tw3V/oR5 3 IeD7v-)eT ndLtuR eb e ytv oPe ntChtIse. obyc cPuCrrIe anncde oonf etw IDo- TIDL-Rn oenv-eTnLt TbyV RC AevBeGn.t sT hbey ICDA-nBoGn -aTnLd T oVnRe rIaDt-en wona-sT L0 .6% QCA Results at 6 Months Absor(bN B =VS 3 4S)ystem X(NIE =NC 6E6 V) p-value cbwoee nrtetrre osalelteeleddc, wtseiidnth gb laea -smbeldain xodim,n mupmruol txoiicfm etnawtl eoar n dtdrei adnl ioscvtoaonl dnDuamctitvaeexd c (imonr aoExnuimaroruyp mea r atdneiardym Nleeetsweior )Zn ebsay. l Saoncnda-.fli fnPoeald tQ iesCnizAtes s ≥c an
A5prar ttoI eD1t o -(TycpeLoeaRlr)r , ,p h t5rihoe etIrDoa Mcr-cToAhLl)CiR cEa,a t la rl3aynt9]de)3 . 2 w Td aIhaDsey- s4nT o.Vw2nFa%- sTr a L(2t1 e.T99 Vw/%4Ra5 s(h01 i4 3e[.r1/7a4 %rc5ca0 h(r)2id c(1iaa9/lc4 lyN 5d]Q)0e.M a [Tt1Ihh a,ec n1 aod3rvd 4eMiar aQcI l M(ld pneIe)oar.n tph-h,r oi1eto3rac MroclIh) ,(i cpaaenlr d M I ISISnntt--eedsnneeoogvssimciissee n%t %D iaDmiaemteert er 1273..5897 ±±89..6418 2135..8237 ±±192..5203 00..2949 22Tbeh..25tew5 xc e mo2e-8nmp rpm itmrome a-≤, r ay 33n .e.d08n pxdm op1smo8ti-n nmatsintm rdaa ,rtl eee3 s.a10iot) n3xv al2yes8enoa gmmrtshom s(t si,o≤ u3n p.4 5ea8 rsxi osm 1erims2tys .)me ,Td mah nbe,d y 3s c2.t5uh)d axmyn 1igsn8eiizm eminsu m mmin, e claualnunmdd le eu3n m2. 5d.e5 inax mx 2d 18eia8t mem rme mtme.r,
8In. 4th.3e subSseutm omf fairrsyt o2f5 0C lpinatiiceanlt sR tehsaut lrtesa cohuetd t o2 -2y eyaer aforsll o(wIn-tuepr i(m75 D8a dtaay Cs)u (t1o9ff )July 2013 In-device Late Loss (mm) 0.14 ±0.18 0.12 ±0.26 0.68 aintf e3r iyoeraitrys, rpeoflsetx- ntoit rsautep emriionruitsy )m. iPnaimtieunmts luwmille bne d cialimniectaellry p foosllto-wpreodc eadt u3r0e dpaoysst-,n 1it8ra0t ed a(nyos,n -and
d(7a.t3a% c)u.t )T,L tFh earned w TaVsF ornaete sc awsee roef aclsaord lioawc daet a6th.9 a%n da ntdh e8 7.15%8-, draeys pMecAtCivEe lay.n Fdu rrathtee rw, tahse loAwR C In-segment Late Loss (mm) 0.11 ±0.29 0.08 ±0.28 0.72 abte 1e,v 2a,lu aantedd 3 a yt e3a ryse apross bt-apsreodc eodnu rime. aTghineg m wohrpichho lwogilli cinacl lausd ew aenll gaiso gfruanpchtiyo, nIVaUl rSe s/p IoVnUsSe- vwiritllu al
dweafsin 0ed.8 d%e.finite + probable scaffold thrombosis rate through 758-days for this population 8.5.2 1-year Propensity Analysis histology, and Lipiscan, with MSCT evaluation at 3 years.
Prior to propensity adjustment, a total of 314 Absorb BVS pooled from Cohort B and an 8.6.2 Summary of Clinical Outcome Data
Table 6: ABSORB EXTEND Subject Counts of Ischemia-driven Adverse Events through interim dataset from ABSORB EXTEND, and 905 XIENCE V patients pooled from SPIRIT The ABSORB II RCT trial completed its enrolment on June 4, 2013 with a total of 501
758 Days (250 Subjects Registered Population) FIRST, SPIRIT II, and SPIRIT III with 1-year follow-up were available, irrespective of the device patients: Absorb BVS (N = 335); XIENCE (N = 166). One-year follow up data are
30 Days, 6 Months, 1 Year, 2 Years, s5i.z6e4s% u s(5e1d /f9o0r5 t)h,e rier strpeeactmtiveenlyt.. Their unadjusted 1-year MACE rates are 5.41% (17/314) and summarized in this section.
EHPevieer rnaptrrscohtoiccaoll, (30N ± = 7 2 d5a0y s) (180N ± = 1 245 d0a ys) (365N ± = 2 285 d0a ys) (730N ± = 2 285 d0a ys) RrcnMeooemAh slCooauErnilntt,gss eae :dw nrA dfistof httTrae rtLttih hsFtehet i( ecmTc aaopolrlrmygso etppd tsae ifLtnrfraeesiktrsiitievinyoeng n ta a dcbFnjheaauatilswlynutsmgerieeese ns.dn AeoAt,fnb bi2n ssie8meod2rrpv b aAer osdBbv VscienoSad rr tbdahb ineaaBd lcaVl e nXSdscI eiEoaeaNnn twhCd c, aE 5hst aa8V rar3 gacc ceXhottIih eEevorvNeirsesCttdssiEc .e b slTV e,rh tewpwela aheMttieieceIndh,n ItbMwDso -eItT hrLe R, t4AaAhn.bse8d s %s XoshI rtEovbeNsw nB.Ctn V3Et hSi..n0r oTa%Tmhna edfbbo l1oXre -sI TEy1isLeN1.Fa C, Tr (E thpTh e Lae=sr Fmoe a v0sane. dr3dhav 4aleMl7d rssA3 nae)Cof; e Ec atc aynrara ddratd ieno5isdav. 2 cawp% sdeec rervufeaosl tarc.h mro3, ema.a0vnnpe%cdnae rtlf aooorbawrf l teM etrh sabAe tew eCAtswEeb r oese(fpeo gn Mr=be tI nh,B e0erVre .a2tSvwl8la ywos3 cce2duor)ee.lma v Bsripcioizmaetarh atiali abormrlne st so,:
MACE 2.0% (5/250) 2.8% (7/250) 4.4% (11/250) 7.3% (18/248) and ID-TLR) rates were comparable between both adjusted cohorts at 37, 193, and 393 between the two treatment arms except for MI, which was trending higher in the Absorb
TVF 2.0% (5/250) 3.2% (8/250) 4.8% (12/250) 8.1% (20/248) rdaatyess. rAem suaimnemda cryo mofp kaerayb 1le-,y weaitrh o au tncuommeersic iasl lsyh loowwne ri nra Ttea bolbet a9i.n eAdft efor ra Adjbussotmrbe BnVt,S th (e4 .M15A%CE, BloVwSe ra rinm t h(4e. 5A%bs vosrb. 1B.V2S% ,a prm = ( 30..60%5 4v9s). a7n.3d% fo, rp a =ll r e0v.0a7s5cu8l)a. rTizhaeti oAnR, Cw dheicfhin iwtea ss tetrnetn /d isncga ffold
TLF 2.0% (5/250) 2.8% (7/250) 4.4% (11/250) 6.9% (17/248) 11.7/282) versus XIENCE V (5.63%, 32.8/583). The respective scaffold / stent thrombosis thrombosis rates were similar between BVS (0.6%) and XIENCE (0.0%) (p = 1.000).
Nhcoioeunran-MprtrcsIo ht(iopcceaorl l) 2.0% (5/250) 2.4% (6/250) 2.8% (7/250) 4.0% (10/248) raCattle i1ns i cyweaela rrOe Tunatocbtol esm t9aet:si sC t ilcinailclya ld OifAfu(ebNtrcse oo=nmrt b (2e 0B8s.4V2 a0)St% 1 vYse.a 0r. 5fr2o%m(X,N tIp hE= e=N CI5 P0E8S. 38VW)0 -)A.djusted Cohpo-vrtaslue Safety (Non-HierarchicTaal)blAe(bN 1s 1o=:r b C3 lB3inV5i)Sc al O(NuXt cI=EoN m1Ce6E 6 t)h rough 1 DY(i9ef5faer%re nCcI)e p-value
Cdeaardthiac 0.0% (0/250) 0.4% (1/250) 0.4% (1/250) 0.4% (1/248) M[9A5C%E C I] [1.824%.1, 56%.4 7%] [3.765%.6, 37%.5 0%] 0.35 Death % 0.0% 0.6% [-3.3-50%.6, 10%.65%] 0.33
Ischemia- M[9I5 % CI] [0.772%.6, 44%.5 1%] [1.252%.5, 23%.8 0%] 0.92 Cardiac death % 0.0% 0.0% 0[.N0A0%] 1.00
dTrLiRve n 0.4% (1/250) 0.4% (1/250) 2.0% (5/250) 4.0% (10/248) I[D9-5T%L RC I] [0.331%.9, 53%.5 6%] [1.703%.1, 04%.5 1%] 0.33 All MI 4.5% 1.2% [-0.243%.3,3 6%.29%] 0.055
IdTsrLci vhTeeVnmR ni ao-n- 0.0% (0/250) 0.4% (1/250) 0.8% (2/250) 2.0% (5/248) T[9L5F% CI] [1.824%.1, 56%.4 7%] [3.305%.0, 96%.8 7%] 0.54 QMI 0.6% 0.0% [-1.710%.6,1 2%.18%] 0.55
Definite / Probable
ST(PAhrcoRraobCffm)o Dlbdeo fs /is 0.4% (1/250) 0.4% (1/249) 0.8% (2/249) 0.8% (2/246) DST[i9hcs5rcao%fufmso CslbdiIo]o /sn iS:s t Te hnet propensity [s0c.0o0%re., 4 a10d.%j1u4s%te]d method[ 0ac.0h0%ie.,5v e12d.%1 t1h%e ]intent of balanc0i.n8g0 the Sthtreonm t /bN oSQscMiasf If(oAlRd C definite) 03..69%% 01..02%% [[-101.7.7720%%..7,6, 3 2%5%..1565%%]] 01..00905
12.. DTLaRta =ar et a%rg e(nt ulemsbioenr roefv sausbcjuelcatrsiz awtiiothn ,e vTeVn =t / ntaurmgebt evre osfs eslubjects) bAaBsSeOliRneB cahnadr aScPteIRrisITti ctrsia blse.t wTheee na dbjoutsht eXdIE rNesCuEl tsV sahnodw Aebds othrabt BAVbSs ogrrbo uBpVsS f riso mco dmifpfearreanbtl e to Effectiveness (Non-Hierarchical)
3. MiscAhCeEm =ia- mdraivjoenr aTdLvRe)rse cardiac events (composite endpoint of cardiac death, MI, tahned X1IE yNeCarE aVft esrt einmt pfloarn itna-tisotnen, ta nladte f ulortshse ra tc 6o nmfiromntsh sth ae ncdo mfopr acrlainbiciliatyl obuettcwoemeens A abts 6o rmb oBnVtShs ID-TLR 1.2% 1.8% [-4.0-80%.6, 11%.61%] 0.69
4. TLF = target lesion failure (composite endpoint of cardiac death, TVMI, ischemia- and XIENCE V in the above parameters found in the unadjusted data.
5. dTrVivFe =n TtVarRg)et vessel failure (composite endpoint of cardiac death, MI, ischemia-driven 8A.s5 o.3f the d2a-tyae caur t-Porfof poenn 1s9it yJu Alyn 2a0ly1s3i,s prior to propensity score matched analysis, a total ID-TVR, nonTLR 0.9% 1.8% [-4.3-50%.9, 11%.19%] 0.41
ConcluTsLiRon, :is Tchhee minitae-rdimri voeunt cNoomne-TsL fRro TmV RA)BSORB EXTEND further demonstrate the 12- and omf a2tc5h0i nAgb, s1o7r8b ABVbsSo arbn dB V88S7 a XndIE N29C3E XVI EpNaCtieEn Vts pwaetireen tasv areilmabalien ethdr ofourg hth e2 cyoemarps.a rFaotlilvoew ing ID-NTVR 1.5% 2.4% [-4.6-50%.9, 11%.56%] 0.49
24-month safety and performance of Absorb BVS in a larger population of subjects where analysis.
longer lesion can be treated. Patients will be followed for up to 3 years. Rsiemsiulalrts b: eAtwfteere np rtohpee Ansbistyo rsbc BorVeS m caothcohretd a naddj uthsetm XeIEnNt,C 2E- yVe acro MhoArCt E(6 a.7n%d TvLsF. 8ra.9te%s froerm MaiAnCedE , ID-revascularization 2.7% 5.5% [-7.4-92%.7, 30%.76%] 0.13
8R.a5t ionale Parnodp eMnesitthyo Sd:c oArbeb Aotdt juVsatsecdu lAarn aisly ussisin ogf itAsb lsaorgrbe BboVdSy S oyfs hteismto raicnadl XcIliEnNicCaEl dVata on aIDn-dT L6R.2 a%n dv sc. a8rd.2ia%c fdoera TthL Fr,a rtees apse cctoivmelpya).r eTdh eto A thbes oXrIbE NBCVSE Vco choohrot retx, hailbthitoeudg ah ttrheen dd iofffe lroewnceer s All TLR 1.2% 1.8% [-4.0-80%.6, 11%.61%] 0.69
XIENCE V stents as a control group for comparison against the currently available Absorb were not significant. The 2-year TVF rate was also numerically lower in the Absorb BVS
BvaVlSid csltianticisatli cdaal tma eutthiliozdin tgh atht eis p wroeplel nascictye pstceodr ae nmd ectohmodm. Ponrolyp eunsseidty i ns cthoere c alinnaiclyasl itsr iaisl, aa nd gthrrooump b(o7s.3is% r avtse.s 1 w2e.3re% s, ipm =ila r0 b.0e9tw).e Tenh eA abdsjoursbt eBdV dSe fainnidte X /I EpNroCbEa bVl ea ts 2c ayfefoalrds /( 0st.e6n%t ; 95% CI All TVR, nonTLR 1.8% 3.6% [-6.2-81%.8, 20%.6 7%] 0.23
isnt usdcieiesn.t iTfihci sa nadp psrtoaaticshti caadl jucsotms mfour ntihtiee sb afosre ltihnee cimombaplaanricseo nb eotfw deaetna tfhroem te nsot na-nrda ncdoonmtroizle d [s0h.o0w1n% ,b 3el.o0w9% in] Tvasb. l1e. 41%0;. 95% CI [0.37%, 3.46%], p=0.65). A summary of the key data is All NTVR 1.8% 3.6% [-6.0-01%.8, 21%.05%] 0.23
gbborieuaottswcu opeinmse ,nt ehc sterh e becae ottcewmoso pma ag erbra oemtiutvtopeersr e a m anrreaaellti yacmsbhiol sebr..ee AK twbfetaeeylre ar nnpe csrboeuopdltte,sh n a fgsnoridtroy uat hsp 6ecs-ro,me rafeoon rnadedt ,hh jut ehasnentcm dec ,eoa nrm e1t,dp- ybuaeacriasesreso lp nirnrseoea po lc efah ntnahsdreiat ypcc otlaeitnneriiancsltatyiialcs lsi s Catl i2n icyeala rOTsaubtcleo m10e:s C linical OutcA(obNms o=ersb 1 aB7t8V 2)S Years from th(eXN II EP=NS CW2E9- A3Vd) justed Cohopr-tsvalue CAlol mRepvoassitceu lSaarifzeattyio annd Effective3n.6e%ss (Hierarc7h.i3c%al) [-8.8-83%.6, 40%.39%] 0.076
acwdoedmigitphioatenridan lg (dI PAaStbaWs ofr)ro bmm Be oVthnSog dtoo12i n.X gPI ErtoNripaCelEsn sbVie tydc aoatmna aeal yraesv ipsa irlaeatsb ellaent.te eTrd ht ieum sreein spguo ltithnset so i fnw vthiellir ssb ece o pcmroonppdaerunicssotietnyd asarcseo re C[9a5rd%ia CcI ]Death [0.000%.,0 2%.05%] [0.371%.,4 3%.46%] 0.30 TIDL-FT L(cRa)r diac death, TVMI, 4.8% 3.0% [-2.461%.8,2 5%.18%] 0.34
b8T3he..05iinr .txg1y -1 ce8oig nmhf6tim r-pmm asetotideen nnttththssr ofPfrurorogommhp AeoSnnBPgsSIRoiOtiIyRnT gB AF cnICRlaionSlhyiTcos araitlsn Btdr i aGSlrsPo.IuRpIT 1 I Ia wndit h7 36 -XmIEoNnCthE QVC pAa tdieanttas atrreea utesde dw fitohr M[I[D99I-55 T %%L RCC II]] [[11..926543%%..,,54 87%%..6169%%]] [[21..388943%%..,,48 76%%..4672%%]] 11..0000 TMMMVIAI,,F C IIDD(Ec-- aTT(crVLdaRRira)d)c ia dce daetha,t ha,l l all 55..51%% 43..80%% [[--42..214902%%..61,,12 45%%..4533%%]] 00..7288
t(Rah3nei/sds7 u366l)-6t,ms r(:o eXTsnIEhptheNe cCaptnEriova eVplyle)ys n.firssoi.t myT h stehcieor ru3en8 aa addnjjuudss t7tme3de, n6ret- smypieoelncdttehivd eM alyAd, CjiunEs ttrheadet e ussan amardepj ule2s .ts6ei3dze% as r (mo1f/s 33. 84T) h (aAen badsd o4jur.bs1 t1Be%dV S) T[M[99LA55FC%% E CC II]] [[33..1523%%66,,.. 2711%%01..7498%%]] [[55..3828%%88,,.. 2911%%12..9743%%]] 00..4479 *Pr ePovoCaCEsE c( u–all alP rdaizetaiaettinhot,n Oa)*lrli eMnIt,e da llC ompo7s.3it%e Endpoint9.1% [0.430%.,8 1%.48%] 0.47
2 Rosenbaum PR. Model-based direct adjustment. J Am Stat Assoc. 1987;82:387–394.
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8.7 Benefit of the Absorb Bioresorbable Scaffold Technology 10.4.2 Dual Layer Sheath Removal 10.7 Further Expansion of the Deployed Scaffold
In the ABSORB Cohort A clinical investigation, Absorb BVS showed excellent long-term
clinical outcomes with low MACE rates out to 5 years with absence of any cardiac death, 1. While holding the distal catheter shaft with one hand, grasp only the yellow outer 1. DEPLOYED SCAFFOLDS SHOULD NOT BE LEFT UNDERDILATED.
ID-TLR, Q-wave MI, and scaffold thrombosis. The ABSORB Cohort B clinical investigation sheath with the other hand and gently slide the sheath distally. Deployed scaffolds should be well-apposed to the vessel wall. To achieve optimal
confirms these findings out to 3 years, including patency comparable to XIENCE V. 2. A longitudinal split on the inner sheath will open up and be visible. scaffold apposition, postdilatation is recommended with a low profile, high pressure,
Additionally, one-year ABSORB II RCT and ABSORB EXTEND clinical outcome data again 3. The stylet and dual layer sheath are removed simultaneously from the delivery noncompliant balloon that is up to +0.5 mm larger than the nominal scaffold
demonstrated and confirmed the safety and performance of the Absorb BVS with comparable system by continuing to slide the yellow sheath distally until the inner and outer diameter as long as the postdilated segment is within the allowable expansion
MACE, TLF, revascularization (ID-TLR), and stent / scaffold thrombosis rates as the layers of the dual layer sheath as well as the stylet are free from the catheter limits of the scaffold. The scaffolded segment should be carefully recrossed with
commercially available XIENCE. system. See section 6.1 Scaffold Handling – Precautions. Do not use the device if a prolapsed guide wire to avoid disrupting the scaffold geometry. Postdilatation
the sheath cannot be removed as indicated. must only be done with balloons sized to fit within the boundaries of the scaffold.
Apdoibstsaeopnrptbiea aBl rbVaeSnn cteehf iuotssf rpteheseru fsoltcrinmagfsf o farldoll m athl lteoh wefu san bfcostireo ntnhcsee o pofo fa sa sd ipbrueilgritm-ye alounfte ivnnagt s msctueeltnaartl liwhce hiamilleinp ogla fnfaentr.d inT grhe esf utgotruraardetiu oanl of 4. Vnoer isfcy atfhfoatld t hsetr suctsa faforeld l ifdtoedes. Dnoo tn eoxtt eunsde bife ayonnyd d tehfee crtasd iaorpea nqouete bda.lloon markers and Trthehaveti e ctwhoeem dsp cpliarafionforcl edto ci sdh ianlarottt a ootfivo tenhr e-a dnnidloa ntaecnod m.a pTpphlierao nspctr iabafatfeoll lodmo danix lsaimetaluteimocnt e pldirm emsitsu iussrt e0b .eu5 s cmeadmr et ofau bellonyvs eu re
Vveasssoeml ofutnocr tFiounn catsi odnis Rceusssueltds iant t2h eY eVaasrso m– o8t.o2r. 5Fu Dnicstciouns sRieosnu).lt sT haet 2ab Yseeanrcse ( soef cat iopnersm 8a.n2e.4n t 10.4.3 Guide Wire Lumen Flush the nominal diameter for all scaffold sizes.
metallic implant in the vascular tissue may facilitate any required re-interventions on the CAUTION: Do not dilate the scaffold beyond the dilatation limit which is 0.5 mm
target vessel / lesion or side branches either by percutaneous or surgical means, thus Flush the guide wire lumen with HepNS until fluid exits the guide wire exit notch. above the nominal diameter. Over-dilatation may result in scaffold damage.
eunbnnoioalnirkb-eielsni novpgraeb sraami vbbealre noC easTndc teao rmfrf orMealtdnRa glm eeim vaoaypfl ulbtaraenet taimsot,nm op.r eoeTn lhytc imoso mpeptrrpiioocanv tiisimdb elaepsf lt awetnhri ttebhs i aodthdroeed s intgoioorrtonp wcatialoi nubngse oenu fesi mtfahitgae teg hs iaonctgfa a fnaf ooprntlodif-l.aiy ncFmvtinsae asrdiliclvuye ,r i ng 10dN.ios4tr.eu4:p tA tvDhoeeid lp imvlaecarenymi pSeuynlastt tioeofmn t h oPef rtsehcpea afsfrcoaaltdfif ooonlnd twheh iblea lfllouosnh.ing the guide wire lumen, as this may Nominal S2c.a5f fmolmd Diameter MaximumD piloa3st.at0dt0iiol anmt aLmtiim onit diameter
fmolalonwag-eump eimnta agnindg ptrhoavnid iisn gth eec coansoem wicit hb emneeftiatslli.c stents, potentially facilitating patient 1. Prepare an inflation device / syringe with diluted contrast medium. 3.00 mm Maximum po3s.t5d0il amtamti on diameter
9.0 PATIENT SELECTION AND TREATMENT 2. Athteta pcrho daunc itn.f lDaotio nno dt ebveincde t/h sey prirnogdeu ctot hsytoppoctuobcek ;w ahtteanc hc oitn tnoe tchtein ign ftloa ttihoen ipnoflratt ioofn 3.5 mm Maximum po4s.t0d0il amtamti on diameter
9Ttjuhh.de1eg AImrnibsdeskinovstri dbare unGgadTal ibr1zdea iBnntiVegofS nirt isSso kydf seTotsrfee cmaarnit.bmt iePpdeala ntaitetebnloet vts eteh sleehrcaotpiuoylnd. Sfbapece tccooiransl s tciodo enbrseei dda esfrosaret iseosanec dsh h spohauotlidue lndbt e ibn geciflvouerdnee utos itnhgo se 34.. dWOneepiuvtehitncr a tehtl h e/fe o s trisy pctr oiodnpnogctwero.ancs,kt otforilil e.dnet litvheer yd eslyivseterym s; ypsutell mne vgearttiivcea lflyo.r 30 seconds; release to 2. Iaoafrr veemea rno,la oripet g pitsaeh pdass nub gbyoge naetew s mtAeeeibdnns imt ohsraucbtam ,Gf ft oTool1 fda 1svB ,oV mtiSdhm e ti sh ba eann lpedloeo aodte nemn dmta itaxaoli rm fkcoeourrmv geb arao pntfh dr4ees s mleotesfm nitoo.h nseT oi ass n,ee dtcnh osbeuna srdlelc o Aatohbfnfaso-totl drtrehbsae tbreeed
pAanttiiepnlatste wletit hd rruegcse nsthlyo ualcdt ibvee guassetdr itinis coorm pbepintaicti ounlc ewri tdhi stheaes Aeb.sorb GT1 BVS per ACC / AHA 5. Calllo asier. the stopcock to the delivery system; purge the inflation device / syringe of GreTc1o mBVmSe nsdheodu lndo bt et op oussieti omnoerde itnhsaidne t wthoe Adbespolorybe GdT s1c aBfVfoSld t op rtiroera tt oo neexp leasnisoion.n. It is
aascnnaddf fEtohSledC sA gBauSniddO eRtlhiBne e Csslp.i nePicchiafyilsc ti rcniiaealensd,s s cs oohufo piunlledddi v uwisdieut hat hlt ehp eai ntcifeounrrtrmse,na ttto iol itdnee rftareotrummre itn hoeen t ShdePru IsRgp-ITee cluCiftliiicnn giac nsattl ieptnrliatastle s/l et / 67.. RpIfr eoap dseuyacrt tin.sgteep sw a3s t hursoeudg, ha t5ta ucnht ial apllr eapira irse de xinpfelallteiod.n Ifd ebvuibcbel etos tpheer ssitsotp, cdooc nko.t use the 3. GrEenOssOuulDtrse . S tRhCeeA pFfeiFnaOat lL inDscf lAaaftPifooPnlOds S duIiTnaItmOil Neat.ce hRr iemecvaoetdnc.fhirems tshcea frfeofeldr epnocsei tivoens saenld d aianmgieotgerra tpoh EicN SURE
anticoagulation dose and duration to be used for their patients in general practice. A 8. Open the stopcock to the delivery system.
minimum of six months' duration is recommended. 9. Leave on neutral. 10.8 Removal Procedure
Irte ciso vmemrye inmdpaotirotnasn.t Pthraetm thateu rpea tdieisnct ocnotminupalyt iownit ho ft hpere psocsritb-epdro acnetdipulraatle alentt impleadteicleatt ion could Note: The labeled scaffold diameter refers to expanded scaffold inner diameter. Wsciathffdorladw:al of the scaffold delivery catheter / postdilatation balloon from the deployed
result in a higher risk of thrombosis, MI, or death. Prior to PCI, if a surgical or dental 10.5 Delivery Procedure
procedure is anticipated that requires early discontinuation or temporary interruption of 1. Deflate the balloon by pulling negative pressure on the inflation device. Larger and
antiplatelet therapy, the interventionalist and patient should carefully consider whether 1. Prepare the vascular access site according to standard practice. longer balloons will take more time (up to 30 seconds) to deflate than smaller and
an everolimus-eluting scaffold and its associated recommended antiplatelet therapy 2. Predilate the lesion to match the reference vessel diameter with a percutaneous shorter balloons. Confirm balloon deflation under fluoroscopy.
are the appropriate PCI choice. Following PCI, should a surgical or dental procedure be transluminal coronary angioplasty catheter. Predilatation is strongly recommended 2. Position the inflation device to “negative” or “neutral” pressure.
recommended, the risks and benefits of the procedure should be weighed against the and can also be utilized to properly size the vessel. 3. Fully open the rotating hemostatic valve.
possible risk associated with premature or temporary discontinuation of antiplatelet therapy. Note: Limit the length of the predilatation by the PTCA balloon to avoid creating a 4. Stabilize guide catheter position just outside coronary ostium and anchor in place.
Patients who require premature discontinuation of antiplatelet therapy secondary to region of vessel injury that is outside the boundaries of the Absorb GT1 scaffold. Maintain guide wire placement across scaffolded segment.
significant active bleeding should be monitored carefully for cardiac events, and once 3. Administer a standard dose of intracoronary nitroglycerine prior to finalizing the RVD 5. Gently remove the scaffold delivery system with slow and steady pressure.
sthtaebiri ltirzeeadt,i nhga vpeh ythseiciria annst.iplatelet therapy restarted as soon as possible per the discretion of 4. wMiathininta tinh en teaurtgraelt pzorenses.ure on the inflation device. Open the rotating hemostatic valve 6. Tighten the rotating hemostatic valve.
as widely as possible. If, during withdrawal of the catheter from the deployed scaffold, resistance is
10.0 CLINICIAN USE INFORMATION 5. Backload the delivery system onto the proximal portion of the guide wire, while encountered, use the following steps to improve balloon rewrap:
10.1 Inspection Prior to Use maintaining guide wire position across the target lesion. • Re-inflate the balloon up to nominal pressure, deflate and change pressure to
Prior to using the Absorb GT1 BVS System, carefully remove the system from the package 6. Advance the delivery system over the guide wire to the target lesion. Utilize neutral.
and inspect for bends, kinks, and other damage. Verify that the scaffold does not extend radiopaque balloon markers to position the scaffold across the lesion; perform • Repeat steps 1 – 5 above.
beyond the radiopaque balloon markers and that it is still well-crimped onto the balloon angiography to confirm scaffold position. • Re-evaluate the scaffolded region once the balloon is removed to assure optimal
catheter. Do not use if any defects are noted. Note: If removal of a scaffold system is required prior to deployment, ensure that apposition.
10.2 Materials Required tshyes tgeumid aen cda tchaeutetiro uiss lcyo waxitihadllyra pwo sthiteio snceadf froellda tdiveeli vtoe rtyh es ysscteamffo lidn tod etlhivee gryu iding Note: rAefsteisr tsauncccee bssef ufel ltw aitth adnrayw taiml oef wthhee bna wlloitohnd rfarwomin gth teh ed espclaofyfoeldd sdcealifvfeorldy, ssyhsoteumld aorn y
•• 6f2oF r– / t 3h0e .s 0tya7rri0ng"ge /te s1v e.(8s1 s0me l–m 2m0i ncicm)um inner diameter guiding catheter(s) of appropriate shape dcsccaairattehhfcfeetott eelvdrri.s isuSnhathooloi uzutalhdltdei o bugnenu wriudesiemtuh ca ofalvl utreheodesr toiaesssrt,ca otanhp cesye i.sn bcgaele fff oeullntd i atd.t eTalihnviyesr tysi mhsoyeus lwtde hmbee na dnwodin tthehd eur angwdueiindr ge the psdioenlsigvtdleeirl yau tnsaiyttiso. tnSe mebea rlsleoemocnoti ovinantl o6in .t4sh terSu cgcautifiodfonels dc. a/ thSeytsetre, mre mReomveo vthael –e nPtrierec asuytsiotenms faosr sap ecific
• 1,000 µ/500 cc heparinized normal saline (HepNS) 7. Tighten the rotating hemostatic valve. The scaffold is now ready to be deployed.
• 0.014 inch (0.36 mm) x 175 cm (minimum length) guide wire 11.0 TRADEMARKS
•• RCootnattriansgt hdeilumteods t1at:i1c wvaitlhv en worimtha 0l .s0a9li6n einch (2.44 mm) minimum inner diameter 10.6 Deployment Procedure AGbrosuoprb o, fA Cbosmorpba GniTe1s,. XIENCE, XIENCE PRIME, and XIENCE V are trademarks of the Abbott
• Inflation device 1. CAUTION: Refer to product label for in vitro scaffold inner diameter, nominal CYPHER is a registered trademark of Cordis Corporation in the U.S.
• Three-way stopcock pressure and RBP. Certican, Afinitor, Votubia, and Zortress are registered trademarks of Novartis
• Torque device 2. Prior to deployment, reconfirm the correct position of the scaffold relative to the Pharmaceuticals, Inc.
• Guide wire introducer target lesion using the radiopaque balloon markers.
10.3 Vessel and Lesion Selection 3. Deploy the scaffold slowly, by pressurizing delivery system in 2-atm increments,
every 5 seconds, until scaffold is completely expanded. Maintain pressure for 30
• Quantitative imaging is strongly recommended for the assessment of target vessel seconds. Fully expand the scaffold by inflating to nominal pressure at a minimum;
diameter at baseline for appropriate Absorb GT1 BVS size selection. accepted practice generally targets an initial deployment pressure that would achieve
• The target vessel diameter ranges to be treated in the procedure are indicated in a scaffold inner ratio of about 1.1 times the reference vessel diameter.
Table 12 along with the Absorb GT1 BVS diameter to be used. CAUTION: Do not exceed the labeled rated burst pressure RBP of 16 atm
Table 12: Target Vessel Diameter Ranges and Absorb GT1 BVS Diameter to be Used (1621 kPa) or maximum deployment diameter of the scaffold.
(Quantitative Imaging) 4. Fluoroscopic visualization during scaffold expansion should be used in order to
properly judge the optimum scaffold diameter as compared to the proximal and
Target Vessel Diameter Distal and Proximal Absorb GT1 BVS Diameter to be Used distal native coronary artery diameters (reference vessel diameters). Optimal scaffold
≥ 2.0 mm and ≤ 3.0 mm 2.5 mm eaxrtpearinasl iwona lal.nd proper apposition require that the scaffold be in full contact with the
≥ 2.5 mm and ≤ 3.3 mm 3.0 mm 5. If necessary, the delivery system can be repressurized or further pressurized to
≥ 3.0 mm and ≤ 3.8 mm 3.5 mm ensure complete apposition of the scaffold to the artery wall. Fully cover the entire
lesion and balloon-treated area (including dissections) with the Absorb GT1 scaffold,
• If visual estimation is used: allowing for adequate scaffold coverage into healthy tissue proximal and distal to
° Use the predilatation balloon, when inflated, to assist in sizing the vessel. the lesion.
° Plan to upsize the scaffold for in-between diameters to ensure appropriate 6. Deflate the balloon by pulling negative on the inflation device for 30 seconds.
expansion. Confirm complete balloon deflation before attempting to move the delivery system.
• For cases where the combination of target vessel diameter and target lesion length is If unusual resistance is felt during scaffold delivery system withdrawal, pay particular
appropriate to be treated by more than one scaffold size, the selection of scaffold size attention to the guiding catheter position.
can be made per the judgment of the physician. Note: See section 10.8 Removal Procedure for instruction on withdrawal of scaffold
delivery system.
10.4 Preparation 7. Confirm scaffold position and deployment using standard angiographic techniques.
10.4.1 Packaging Removal For optimal results, the entire stenosed arterial segment should be covered by the
scaffold. Fluoroscopic visualization during scaffold expansion should be used in
Note: The foil pouch is the sterile barrier. Sterile product is contained within this one order to properly judge the optimum expanded scaffold diameter as compared to
pouch—there is no secondary pouch. the proximal and distal coronary artery diameter(s). Optimal expansion requires that
1. Peel the pouch open from the top corner. the scaffold be in full contact with the artery wall, which can be facilitated with the
2. Carefully remove the delivery system from its protective tubing for preparation of use of routine angiography, intravascular ultrasound (IVUS), or optical coherence
the delivery system. tomography (OCT).
3. Do not bend or kink the hypotube during removal. 8. Postdilatation with a noncompliant balloon is recommended following instructions
in section 10.7 Further Expansion of the Deployed Scaffold, as long as the
postdilated segment is within the allowable expansion limits of the scaffold.
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Deutsch / German 1.0 PRODUKTBESCHREIBUNG 3.0 INDIKATIONEN
Das Absorb GT1 bioresorbierbare vaskuläre Gerüstsystem (BVS) umfasst folgende Das Absorb GT1 BVS ist ein temporäres Gerüst, das für die Optimierung des
Absorb GT1 Komponenten: Lumendurchmessers von Koronararterien vorgesehen ist. Es wird mit der Zeit resorbiert und
kann eine Normalisierung der Gefäßfunktion bei Patienten mit ischämischer Herzkrankheit
• Ein vormontiertes Gerüst, das aus dem Polymer Poly(L-Lactid) (PLLA) besteht und aufgrund von De-novo-Läsionen in nativen Koronararterien bewirken. Die Länge der Zielläsion
Bioresorbierbares vaskuläres Gerüstsystem mit einer Mischung aus dem proliferationshemmenden Wirkstoff Everolimus und dem muss unter der nominalen Gerüstlänge (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) liegen, der
Polymer Poly(D,L-Lactid) (PDLLA) in einem Verhältnis von 1:1 beschichtet ist. Die auf Referenzgefäßdurchmesser sollte ≥ 2,0 mm und ≤ 3,8 mm betragen.
VInEhRaSltCsvHeRrEzeIBicUhNnGisSINFORMATIONEN dem Gerüst aufgeTbarbacehlltee 1E:v Weroirlkimstuosff-gDeohsaislt iismt i nA bTsaobrebl leG T11 a BnVgeSgeben. 4D.a0s AbsorKbO GNTT1R ABIVNSD-ISKyAsTteIOmN iEsNt kontraindiziert zur Anwendung bei:
1.0 PRODUKTBESCHREIBUNG Gerüstdurchmesser Gerüstlänge Wirkstoffdosis • Patienten, bei denen eine Behandlung mit Thrombozytenaggregationshemmern
Tabelle 1: Wirkstoffgehalt im Absorb GT1 BVS (mm) (mm) (μg) und/oder Antikoagulantien kontraindiziert ist
Tabelle 2: In-vitro-Produktspezifikationen 2,5/3,0 8 76 • Patienten mit einer bekannten Überempfindlichkeit oder Kontraindikation gegen Aspirin,
234...000 LIKNIOEDNFIKETRARTUAIINONGNDEIKNATIONEN 22,,55//33,,00 1128 111841 HPvooerlpyba(eLrhi-naL naudcnetdild t B)w,i veParoldilryeu(ndD ik,nLö,- nLCnaleocnptiidd)o, gPrleal,t inT iocldoepri dKion,n tPrarasstmugitrteell ,u dnide Tniiccahgt raenlogre, mEveesrsoelinm us,
5.0 WARNHINWEISE 2,5/3,0 23 228 5.0 WARNHINWEISE
6.0 6V.O1R SICVHorTsSicMhAtsSmSaNßAnHaMhmEeNn bei der Handhabung des Gerüsts 2,5/3,0 28 276 • Dveierf ümgöbgalriecnh eTnh learnagpfireins tisginend Vnoocrthe iilen dzuesr äktozrliocnhaerne nk lAinbisscohrebn-P Srotudduiketne nimac Vhezurgwleeiicshe nz.u
6.2 Vorsichtsmaßnahmen bei der Gerüstpositionierung 3,5 12 135 • Das Produkt sollte nicht bei Patienten angewendet werden, bei denen die Einhaltung der
6.3 Verwendung in Verbindung mit anderen Verfahren 3,5 18 197 empfohlenen Therapie mit Thrombozytenaggregationshemmern unwahrscheinlich ist.
6.4 Vorsichtsmaßnahmen bei der Gerüst-/Systementfernung • Da mit der Verwendung dieses Produkts das Risiko einer Gerüstthrombose, vaskulärer
6.5 Vorsichtsmaßnahmen nach der Implantation 3,5 23 246 Komplikationen und/oder Blutungen einhergeht, ist eine wohlüberlegte Auswahl der
6.6 MRT-Hinweis 3,5 28 308 Patienten erforderlich.
6.7 Arzneimittelreaktionen • Die orale Verabreichung von Everolimus zusammen mit Cyclosporin wurde mit
7.0 67K..O81M PLSBIKcekhAawTnIaOnnNtegE eKNrsocmhpalfitkationen • VdAiibees rG oareubrfü GdsTtel1änn BEgnVedS vr iounrng tdeeenrr RdEeönsnt ftGagleeturnündsgut rsuc nbhdele funincadchlhitcu hndege r rn öEicnxhtpgta ensniscdiohicnthb tainer Mdisetar)r .kAiretreurnieg eann g(deab edna s • ePBkaraehnti iönePh neettreiesnnnoe Sn maeelünlreus rmmsgeiicstn hcA odhllleeees rsRhgteeaiearlb ikng t-aei ougunfen nvda e uP-rfäto rdnliygide(leyLsrc-etLeesar iLcIdmitwpidpied)la,rp tnPreotnoaf ltiyil nea( DuhV,fieLtnrr-e bLütiaebncnedt.ruidwn)ag, c Eghvete bwrroaelcirmdhetu.n sD. oied er Platin
8.0 788K...L212IN ISMKAClBHöinSEgisO liSccRThhBUee DKPKIoroEühmNfou prMntleigIk T aAv tDo ionEn MAenB ASBOSROBRB BVS-SYSTEM •• ZdGDwiaeesre üA iA srrbtböaesnpiottpgsrlebliäkn naGdtgTiicoe1h n dtsBeesV,s ySu sBn-tSaetelmylros sndte seimm mu n iRBsdtöa dnmlloitegint e P enboibnesifeliidtmnio.d nlRi cadhpeeisd M-nEiacxrhckthie aernnugtnfega-let(enRt eXkne-) nGnezreüicshtsn edne s •• BLIFnüäeshsit irrPouuannmt giweesnnikrttadeet n hv( zeom.tn eiB trd s.ü i eFbksüeleehrimrrn uBeänreßg haisgalssenc nddh liGlueene uMfgsä ießannkbd)rge,ü esdmrtigaemtr eödunßen.eng ekInnon mperpnoadxtuiimbrcleahrlm zFueürsh srouednre gdr seiknsan tehrehtaelrb f üdre r
8.2.1 Methodologie und derzeitiger Stand Gerüstapplikationssystem ausgestattet. das Absorb GT1 BVS-System (Tabelle 2) machen, dürfen nicht mit dem Absorb GT1
8.2.2 Klinisches Ergebnis nach 5 Jahren • Zwei proximale Markierungen auf dem Schaft des Applikationssystems (95 cm BVS-System verwendet werden. Keine 5-in-6- oder 6-in-7-Führungsschleusen in einen
Tabelle 3: Klinisches Ergebnis nach 5 Jahren und 105 cm proximal zur distalen Spitze) geben die relative Position des 6-F- oder 7-F-Führungskatheter einbringen, da dies zu einem Innendurchmesser führt,
8.2.3 Angiographische, IVUS- und OCT-Ergebnisse nach 180 Tagen Applikationssystems gegenüber dem Ende des brachialen oder femoralen der für den Gebrauch mit dem Absorb GT1 BVS-System zu klein ist.
und 2 Jahren Führungskatheters an. Die Katheterarbeitslänge beträgt 145 cm. • Eine Ballondilatation der Zellen eines entfalteten Absorb GT1 BVS kann zu
8.2.4 Ergebnisse bei der vasomotorischen Funktion nach 2 Jahren • Eine Farbänderung des Schafts kennzeichnet die Austrittskerbe des Führungsdrahts. Gerüstschäden führen.
Abbildung 1: Ergebnisse der Prüfungen mit Acetylcholin und Methergin Tabelle 2: In-vitro-Produktspezifikationen • Zur Vermeidung potenzieller Beschädigungen des Gerüsts während der Positionierung
in den proximalen, Gerüst-gestützten und distalen muss bei der Messung des Referenzgefäßdurchmessers der Zielläsion und Auswahl
8.3 88A..B23S..51O RBDM Kiesotkhhuoosdrstoeiol oBng ieS uengdm deenrtzeenit iger Stand Germü(mestsmdsue)rrc h- Ger(ümstmlä)nge Fdü*eh Msru kinnogd(mIseDkps)atagtthirböelßteeenr s ad*Nte*mes nI nGn-edvrriüutkrscoPtks-a Naetmnn–b eRrBstPkdPruack AImrtue nGraieebrng(üo%esbdt)eberecfrlkeäticech he dGLnvoieäecrssrhbü iotGes nmheti armdöünagspdrltlaeiadclunuth ftrw acisstuhcitorm hd(nlBiee eres)ßi cisosehepdntri eiseglrä l s:svd oSsoierttrg,a b vfrdeäiksarl etuskiigesate l lvlzdte eiif weriAzf eabiverhosdrrlcteleeshnn täL.ä twänVzsduoeiinrnogdg nede , nn eIdnar, ifceuBlah nent dihVioc aondhnr itdeed aiillnuLanenätgassget i iomAvononne ng sme isoPiunepasenltas i eRs nvteioteserbtn sda,t eledlorne norses ne
8.3.2 TKalibneisllceh 4e: EHrigeerabrncishsisec fhü rg edoier dgneestaem kltien iKsochheo rEterg Bebnisse für Kohorte B 2,5 8 (6F1/0,8,0 m70m i n.) 6 608 16 1621 68 6.0 von >VO 4R0S I%C HeTrgSiMbtA, SwSirNdA aHbMgeErNat en.
8.3.3 Angiograp(hITisTc-hPeo,p IuVlUatSio- nu)nd OCT-Ergebnisse nach 180 Tagen, 1 Jahr, 2,5 12 (6F1/0,8,0 m70m i n.) 6 608 16 1621 68 6.1 Vorsichtsmaßnahmen bei der Handhabung des Gerüsts
8.4 8A.B3S.4O RB2D E iusXknTudEs N3s DioJanhren 2,5 18 (6F1/0,8,0 m70m i n.) 6 608 16 1621 68 • Nrveousrrt“ e-frDüilrais tdiueemrne ndE eionsdm ePrar olwgdeiuebkdrteasr uvbceehraw cuehnntded nef.ünr. Dnuars eaiunfe d Eeirn Pfüahcrkuunngg baensgteimgembet.n Ne i„cVhet rwenden
88..44..12 MZuestahmodmoelongfaies suunndg d deerzre kitliigneisrc Shteann dErgebnisse bis zu 1 Jahr (Stichtag 2,5 23 (6F1/0,8,0 m70m i n.) 6 608 16 1621 68 • DEnatsfe Grneurnügs tb neiscchht ävdoing t sweeinrdeemn Akpapnnli kuantido/nosdseyr setienme Geenrtüfesrtnemenb,o dlias ieesru dnugr cehin terientee n
fTüarb Zewllei s5c:h AeBnSdaOtRenBe ErhXeTbEuNnDg,) Anzahl Patienten mit ischämiebedingten 2,5 28 (6F1/0,8,0 m70m i n.) 6 608 16 1621 68 kvaonrgne. sDeahse nG.erüstsystem ist bestimmungsgemäß zum Einsatz als komplettes System
KPaotmiepnltiekna)tionen bis 393 Tage (Population: alle registrierten 3,0 8 (6F1/0,8,0 m70m i n.) 7 709 16 1621 72 • Dwaesrd Aepnp.likationssystem darf nicht in Verbindung mit anderen Stents verwendet
8.4.3 fZüurs Zawmimscehnefnadssautennge rdheerb kulningis)chen Ergebnisse bis zu 2 Jahren (Stichtag 3,0 12 (6F1/0,8,0 m70m i n.) 7 709 16 1621 73 • Buisnet ssdaoicenshd gebereemi mVäo ßEr szniutcn hhetah inmsdte hdnaa bdraeeunsf oKzdauet hvr eeintrew irrseg neadnuedsne ,di nedera rsV W eGrepeirasücesk tzu uan ugvf,e drbseecmimh ieB Pbaoellsnoi.nt iA onnmicie hwrte inc hütbigesrt en
Tabelle 6: KAoBmSOpRlikBa tEioXnTeEnN bDi,s A 7n5z8a hTla Pgaet i(ePnotepnu lmatiiot nis:c 2h5ä0m rieebgeisdtriniegrtteen 3,0 18 (6F1/0,8,0 m70m i n.) 7 709 16 1621 73 eHiänmeno sFtüahsreuvnegnstdilsra uhnt ds odwuirec hb eeiimne Vn oFrüshcrhuienbgesnk adthuerctehr adnesna Atzd.apter eines rotierenden
8.5 Propensity-Score-aPdajtuiesntiteernte) Analyse des Absorb BVS-Systems und XIENCE V 3,0 23 (6F1/0,8,0 m70m i n.) 7 709 16 1621 73 • Deianse GBeesrücshtä dniigcuhnt gm dite rd eBne sFcinhgicehrtnu nmga snoiwpuieli eerineen ,V beerurünhreriennig oudnegr ohdaenr dLhoasblöesnu, ndga ddeiess
8.5.1 Propensity-Analyse nach 6 Monaten Gerüsts vom Applikationsballon bewirken kann.
Tabelle 7: DMaAtCenE-Rate nach 6 Monaten anhand der IPSW-adjustierten 3,0 28 (6F1/0,8,0 m70m i n.) 7 709 16 1621 73 • Ngausr feöirnm gigeeenig Mneetdesie nIn fvleartiwonensmdeend, iudma efsü rs doenns tB zaull ounn gvleericwhemndäßenig.e Kr eAinuefd Leuhfnt uondge ru nd zu
Tabelle 8: IAPnSgWio-gardajpuhsitsiecrhteen E Drgaetbennisse nach 6 Monaten anhand der 3,5 12 (6F1/0,8,0 m70m i n.) 6 608 16 1621 73 • SDcieh wImieprliagnkteaittieonn bdeeism G Eenrtüfaslttse nd adref sn uGre rvüosnt sÄ krzotmenm menit keanntsnp.rechender Ausbildung
8.5.2 T1a-jbäehlrleig 9e :P Krolinpiesncshiety -EArgneablynsisese nach 1 Jahr anhand der IPSW- 3,5 18 (6F1/0,8,0 m70m i n.) 6 608 16 1621 73 • dDuier cGhegreüfsüthimrt pwlaenrtdaetnio.n darf nur in Krankenhäusern erfolgen, in denen eine
8.5.3 2-jährige Pardojpuesntiseirttye-nA nKaolhyosert en 3,5 23 (6F1/0,8,0 m70m i n.) 6 608 16 1621 73 • nEointefa allmnsäcßhilgieeß Keonrdoen Rareasrtteenrioesneb ykpaansns -eOinpee rwaiteiodne r(hCoAltBeG D)i ldautartciohng edfüesh rAt rwteerrideenns ekgamnne.nts,
Tabelle 10: Kadlijnuisstciehret eEnr gKeobhnoisrtseen nach 2 Jahren anhand der IPSW- 3,5 28 (6F1/0,8,0 m70m i n.) 6 608 16 1621 74 iLna ndgemze idtearsg eGbenriüssste imnapclahn wtieierdt ewrhuordltee,r eDrfiloartdaetirolinc hv omna ecnhdeont.h Eeslis liieergteenn nGoecrühs kteenin ev or.
8.6 ABSORB II RCT 6.2 Vorsichtsmaßnahmen bei der Gerüstpositionierung
8.6.1 Studienaufbau * Siehe Spezifikationen der jeweiligen Hersteller für entsprechende Größe in (F). • Das Applikationssystem vor der Gerüstentfaltung nicht anders als beschrieben
8.6.2 Zusammenfassung der klinischen Ergebnisdaten ** Überprüfen, ob das Gerüst vollständig entfaltet wurde (siehe Abschnitt 10.6 Verfahren zur vorbereiten oder vorinflatieren. Die in Abschnitt 10.4.4 Vorbereitung des
Tabelle 11: Klinisches Ergebnis bis 1 Jahr Stententfaltung). Der Entfaltungsdruck sollte sich nach den Eigenschaften der Läsion richten. Applikationssystems beschriebene Ballonentlüftungstechnik verwenden.
8.7 Vorteile der bioresorbierbaren Gerüsttechnologie Absorb • Ein unsteriles Temperaturüberwachungsgerät für den Versand und die Lagerung des • Der Referenzgefäßdurchmesser der Zielläsion muss sorgfältig gemessen werden, um
9.0 PATIENTENAUSWAHL UND BEHANDLUNG Absorb GT1 BVS-Systems wird mit dem Produkt geliefert. Vor Verwendung dieses eine Überexpansion des Gerüsts zu vermeiden und eine ausreichende Gerüstapposition
9.1 Individualisierung der Behandlung Produkts die Temperaturanzeige durch das Fenster hinten auf dem Produktkarton zu ermöglichen. Zugleich wird dadurch das Risiko einer Gerüstbeschädigung reduziert.
10.0 ANLEITUNG ZUM KLINISCHEN GEBRAUCH prüfen. Die Temperaturanzeigen-Legende auf dem Produktkarton oder der • Beim Einführen des Applikationssystems in das Gefäß keinen Unterdruck am
10.1 Inspektion vor der Verwendung Packungsbeilage beachten. Applikationssystem anlegen. Das Gerüst kann sich sonst vom Ballon loslösen.
10.2 Erforderliche Materialien 2.0 LIEFERUNG • Am Katheter nicht mehr als eine (1) vollständige Drehung durchführen.
10.3 Auswahl des Gefäßes und der Läsion Steril – Dieses Produkt wurde mit Elektronenstrahlung sterilisiert. Nicht pyrogen. Das Produkt • Beim Vorschieben des Absorb GT1 BVS durch die Läsion vorsichtig vorgehen. Bei
Tabelle 12: Durchmesserbereiche der Zielgefäße und zu verwendender Absorb nicht verwenden, wenn die Packung offen oder beschädigt ist. mehrmaligen Versuchen zum Durchqueren der Läsion kann das Gerüst beschädigt
GT1 BVS-Durchmesser (Quantitative Bildgebung) Dieses Einwegprodukt darf nicht bei anderen Patienten wiederverwendet werden, da es oder verschoben werden.
10.4 Vorbereitung nach dem ersten Gebrauch nicht mehr wie vorgesehen funktioniert. Änderungen an den • Eine Gerüstimplantation kann zu einer Dissektion des Gefäßes distal und/oder proximal
10.4.1 Entnahme aus der Verpackung mechanischen, physischen und/oder chemischen Eigenschaften, die durch wiederholte des Gerüsts führen und einen akuten Gefäßverschluss bewirken, der zusätzliche
10.4.2 Entfernung der doppelschichtigen Schleuse Verwendung, Reinigung und/oder erneute Sterilisation hervorgerufen wurden, können die Eingriffe (CABG, nochmalige Dilatation, Positionierung zusätzlicher Gerüste usw.)
10.4.3 Spülen des Führungsdrahtlumens Integrität der Konstruktion und/oder der Materialien beeinträchtigen. Dies wiederum kann erforderlich macht.
10.4.4 Vorbereitung des Applikationssystems zu Kontamination aufgrund kleiner Risse und/oder Hohlräume sowie verringerter Sicherheit • Das Gerüst nicht expandieren, wenn es nicht richtig im Gefäß positioniert ist. (Siehe
11110000....5678 VVWVeeeerrriffftaaaehhhrerrreee Ennnx zzzpuuuarrrn SSEsnittoeetnfnne ttrdaennpeustpfn laiegkltnauttnfiaoglnteten Gerüsts IuudKnnneöhrdsr apa/Oolectrd rhi–vgege irneEr Llmaieneltvä zi(esßu1rtenup)r gna AeVgcbnek ds rudowenesrgebs nP kGPdraouaTndtn1niueg bnkz ftiutüose h rnPfer üresuohnondr rdeuub/nknioe.td dsrE bceeiahrni nrä BeFedese enR hnvulüe,at cnzsSke ktdvreuseerlä irrlff irüotOeählsrgtris geuGvinnnee.grarl üluubssnettsms uycösnhgtdreil fimecturh;hn eömgih nakt eca(m1nhne) n Rz.iu sE iikno Ffeühr len • LdSGAiitbeeeersg nüpcetsrphnoton sxis niitzmit tu ei6aorin l.neP4ei oe mLVrsäu oiGstnriiogseonif ncäiin ehßm rt dusmiintem egesha iendrßreee nRrmseae dhiLGhimsäeetsneraüifnoloes nnltbg/e SeeGnit eeevdrnroüeütr sr,bv trzeGsiugr/esSetr ortsüserisgtnc tetdh-sni /,eeS. wiyDdnsoeiust drteDcaumuhlrecr e cehLnhi nätdqsfeieuei oGer nMnreu uröunünnggsgdl ti.d-c )/dehaskn epnitr oexinimera len
Temperaturüberwachungsgerät Beschädigung bzw. Dislozierung des proximalen Gerüsts vermieden wird.
Lagerung – Bei maximal 25 °C (77 °F) lagern; kurzzeitige Temperaturschwankungen bis zu • Eine Gerüstpositionierung über Seitenäste mit ≥ 2,0 mm Durchmesser ist zu
30 °C (86 °F) zulässig. vermeiden.
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• Der Ballondurchmesser nach Inflation des Systems, das zur Entfaltung des 6.6 MRT-Hinweis Komplikationen in Verbindung mit der täglichen oralen Verabreichung von Everolimus von
Gerüsts verwendet wird, sollte in etwa dem Gefäßdurchmesser entsprechen. Zur Das Absorb GT1 BVS ist MR-sicher. 1,5 mg/Tag bis 10,0 mg/Tag sind in der Fachinformation und der Produktbeschriftung des
Gewährleistung der vollständigen Gerüstexpansion ist der Ballon mindestens auf den Arzneimittels angegeben.1,2,3,4,5 Die nachstehend beschriebenen Risiken schließen die zu
Nenndruck zu inflatieren. 6.7 Arzneimittelreaktionen erwartenden Komplikationen ein, die für die herzkranke Bevölkerung unter Kontraindikationen,
• Den auf der Verpackung angegebenen Nennberstdruck (RBP) nicht überschreiten. Everolimus wird vom Cytochrom P4503A4 (CYP3A4) in Darmwand und Leber umfassend Warnhinweise und Vorsichtsmaßnahmen in der Everolimus-Produktbeschriftung und
Ballondruck während des Inflatierens überwachen. Die Verwendung eines höheren metabolisiert und bildet ein Substrat für den Antiporter P-Glycoprotein. Everolimus reduziert Fachinformation und/oder in Häufigkeiten von ≥ 10 % in klinischen Studien bei der oralen
Drucks als des auf der Verpackung angegebenen Drucks kann zur Ruptur des Ballons zudem nachweislich den Abbau bestimmter verschreibungspflichtiger Arzneimittel, wenn es Verabreichung von Everolimus für verschiedene Indikationen beobachtet wurden. Bitte die
mit eventuellem Intimaeinriss und Dissektion führen. zusammen mit Cyclosporin (CsA) oral verabreicht wird. Folglich sind bei oraler Verabreichung Fachinformation und Produktbeschriftung der Arzneimittel beachten 1,2,3,4,5 um weitere
• Gerüstbergungsmethoden (Verwendung zusätzlicher Drähte, Schlingen und/oder von Everolimus Wechselwirkungen mit anderen Arzneimitteln möglich, u. a. mit Inhibitoren Informationen und Angaben zu selteneren Komplikationen zu erhalten.
Zangen) können zu zusätzlichen Verletzungen des Koronargefäßsystems und/oder und Induktoren des CYP3A4-Isozyms, und die Resorption und anschließende Ausscheidung • Bauchschmerzen • Veränderungen von Laborwerten
des Gefäßzugangsbereichs führen. Mögliche Komplikationen sind u. a. Blutung, von Everolimus kann durch Arzneimittel, die sich auf diese Abbauwege auswirken, • Anämie (Anstieg von Serumkreatinin,
Hämatombildung oder Pseudoaneurysma. beeinträchtigt werden. Es wurden keine formalen Studien über Arzneimittelinteraktionen im • Angioödem Proteinurie, Hypokaliämie,
• Warzenneni mmiettherleelruei ebrieonrdeseo Srbteienrtbsa erref ovradsekrulilcähre s Ainbds, odrübr fGeTn1 n-uGre brüiosrtees uonrbdi erbare vaskuläre Zuunsda lmokmaleen Whaencgh smeiltw direkmun Agbesno irnb dGeTr 1G eBfVäSß-wSaynsdte dma rdf udrecshhgaelfbü hnrict.h Dt aasu ßReirs iAkcoh ftü gr eslyasstseemn ische • Arterielle thrombotische Ereignisse Heiynpsecrhglileyßkälicmhi eH, yDpyesrlciphiodläemstieer inämie
Absorb GT1-Gerüste, bioresorbierbare vaskuläre Absorb-Gerüste und Everolimus- werden, wenn das Absorb GT1 BVS bei einem Patienten implantiert wird, der ein Arzneimittel • Blutungen und Koagulopathie und Hypertriglyzeridämie; pathologische
eluierende Stents verwendet werden. Potenzielle Wechselwirkungen mit anderen mit bekannter Wechselwirkung mit Everolimus einnimmt. (einschließlich hämolytisch- Ergebnisse bei Leberfunktionstests;
• adDAvorenizenszn h aSe9ahti4mällb rdm iktzeteuemr ldiev meeleurrrp ihmeAlaarbenletgientdianedeb.rentene. nvb ozGnwe .Wr ü-isbrtkeess tcaohbfihfc äuhnntegdti egPn.o DlSyetmer nePtras t aiwenn udtr edknea nnP nan tiecieihnntet eu Gnn etiesrürts sdutigcreehkst tau mvnodtnl äs ndingeder Einvt•eerr oaCglimiYe°Pr ue3sInmA ,a14ml,s2/Pu, 3ong,4rsPa,5u-l eIpunsnph trMieebrsei tsdaoiinrvkeduanemm,r ede Cmnieyt: cdklaeonnsn pE omvreiinrto eliimniguesn-B Wluitrskpsiteogffeel ne rohdöehre Nna khörunnngesnm:itteln •• uttVHhhreurräroosmsmmtteoisnbbpcoofhuztieynsstgco h Speey nnMidsirkcorhomea, n Ptghuirrooppmuartbaho iuetin)sdc h- •• ALuLMyynbämmdnn appnThhhlhimcoorohzmemey v tubeIonnnonfd,ze y HrnHtteiäelauimntuät)rtotokgprelhobiblseinn, Granulozyten
• Die Sicherheit und die Wirksamkeit des Absorb GT1 BVS bei Patienten mit früherer ° Antimykotika (z. B. Fluconazol, Ketoconazol, Itraconazol) • Diabetes mellitus • Übelkeit
Brachytherapie der Zielläsion bzw. Brachytherapie zur Behandlung einer Restenose in ° Makrolidantibiotika (z. B. Clarithromycin, Erythromycin) • Durchfall • Nephrotoxizität (in Kombination mit
einem Absorb GT1 BVS wurden nicht untersucht. Sowohl vaskuläre Brachytherapie ° Calciumkanalblocker (z. B. Verapamil, Nicardipin, Diltiazem) • Dyspnoe Cyclosporin)
als auch das Absorb GT1 BVS wandeln das arterielle Remodeling ab. Die Kombination ° Proteasehemmer (z. B. Nelfinavir, Indinavir, Amprenavir) • Embryonale/fötale Toxizität • Nichtinfektiöse Pneumonitis
dieser beiden Behandlungsarten wurde nicht untersucht. ° Sonstige Wirkstoffe (z. B. Cisaprid, Metoclopramid, Bromocriptin, Cimetidin, • Kopfschmerzen (einschließlich interstitielle
• Eine Nachdilatation mit einem unnachgiebigen Ballon wird gemäß Anweisungen Danazol) • Leberarterienthrombose Lungenerkrankung)
inznuu lrAä bsussnictgehern ndi teEt rx1 pV0ao.7nras Wuiosensisetegtzrrueenn Egzxe, pnda adnsesssi o sGnice hdrü edssat sse nbnteafafcilnhtdedetielta.nti eGreter üSsetgs memenpt foinhnleernh, ajelbd odcehr • CY°P 3AAn4ti-bIniodtiukkat o(rze. nB, .d Rieif admenp iEnv, eRroiflaimbuutsin-W)irkstoffspiegel herabsetzen können: • Lunebde Grsetlöbrsuuncghetn) (einschließlich Hepatitis •• MScuhnmduelrzzeerna
• Ezuinr üncickhgte zeoxpgaennd wieertredse nG.e Erüins tn dicahrtf enxupra enidni eeritnezsi gGeesr üMsta ld ainr fd neanc hF üdhermun Zgusrküactkhzeietehre n in °° ANnicthiktonnuvkulelsoisviad i(szc.h Be. RCeavrebrasme-aTzraepnsink,r iPphtaesneo-bInahrbibitiatol,r ePnh e(zn.y Bto.i nE)favirenz, Nevirapin) • ÜWbirekrsetmofpf,f iannddlicerhek eRita pgaemgeync iEnv-eDreorliivmautes - •• PPaernikkraeradteitrigsuss
den Führungskatheter nicht erneut in die Arterie eingeführt werden. Es dürfen darüber ° Glucocorticoide (z. B. Dexamethason, Prednison, Prednisolon) • Hypertonie • Peripheres Ödem
hinaus keine weiteren Bewegungen in das distale Ende und aus dem distalen Ende ° HMG-CoA-Reduktasehemmer (z. B. Simvastatin, Lovastatin) • Infektion (Bakterien-, Pilz-, Virus- oder • Pleuraerguss
des Führungskatheters heraus durchgeführt werden, da das Gerüst beschädigt oder ° Andere (z. B. Johanniskraut) Protozoen-Infektionen, einschließlich • Pneumonie
• vSBbeeVorilSs ltd-ceSe hzryou sGb tieeergmnrüe swns tdee-ei/rnSidn yeWesnmit dek emZarenseinttnap,t nufwden reksntn punwün äregbhs are erir nnlsä dedu itednen,er trbeF iEnüttn heStr fdcuehinrenrg iuitsntnek gA ad btduhsereccsthhe nnrfüi iczththu r6tre ü.en4cn. ktVfgaoelrtzseoitceghnet nsA mbwsaiorßdrnb.a GhmT1e n AP6.ru8os dfüuhktrbliceSshcech hIrnwiffatounrnmggea rvtisoocnnh eEanvf teürboelirm Aursz naenimgeitgteelbinetne1r,a2k,3t,i4o,5n.en sind auf der neuesten IPNansaefstephokhotzrigiooieepnrnaeteetnhn, im.pe P ri(oto PgolVyrpeoApsmNos)raiv,tv ueJinr Cumis-sVtu-isilartcisuphssleeo- nzi ierte ••• PANyuiersresexcniehvelargs agen
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als Notfall behandelt werden. nicht bekannt. • Arterielle und venöse Nierenthrombose • Wundheilungsstörungen (einschließlich
Hinweis: Für Notimplantationen sollte ein entsprechend dimensionierter Everolimus- 7.0 KOMPLIKATIONEN Wundinfektionen und Lymphozele)
eluierender Metallstent verwendet werden.
7.1 Bekannte Komplikationen
6.3 Verwendung in Verbindung mit anderen Verfahren Die in den klinischen ABSORB-Studien beobachteten Komplikationen beziehen sich auf die 8.0 KLINISCHE STUDIEN MIT DEM ABSORB BVS-SYSTEM
• Die Gefäßvorbereitung bei komplizierten Läsionen kann zwar die Verwendung primären klinischen Ergebnisse hinsichtlich Tod, Herztod, Myokardinfarkt (MI; Q-Wellen- Das Absorb GT1 BVS basiert auf dem Vorgängermodell Absorb BVS. Die klinischen Studien,
verschiedener mechanischer Atherektomieinstrumente umfassen, doch und Nicht-Q-Wellen-Infarkt), Revaskularisation der Zielläsion (TLR; durch perkutane die in Abschnitt 8.0 beschrieben sind, wurden am Absorb BVS durchgeführt.
wurde die Sicherheit und Wirksamkeit einer Verwendung von mechanischen Koronarintervention [PCI] oder Koronararterienbypass-Operation), Gerüstthrombose und Das Absorb GT1 BVS besitzt denselben Expansionsmodus, dasselbe Stützmaterial, dieselbe
Atherektomieinstrumenten (direktionale Atherektomiekatheter, rotationale ischämiebedingte (ID) schwere kardiale Komplikationen (MACE; Kombination aus Herztod, Gerüstbeschichtung und Wirkstoffdichte, dieselben permanenten Gerüstmarkierungen
Atherektomiekatheter) oder Laser-Angioplastiekathetern in Verbindung mit einer MI, ischämiebedingter TLR [ID-TLR]) und sind aufgeführt in Abschnitt 8.0 Klinische sowie denselben Gerüstaufbau wie das Absorb BVS. Das Absorb GT1 BVS unterscheidet
Absorb GT1-BVS-Implantation nicht formal in klinischen Studien untersucht. Studien mit dem Absorb BVS-System. Alle anderen Komplikationen sind beschrieben in sich vom Absorb BVS nur hinsichtlich des Gerüstapplikationssystems. Das Absorb GT1
6.4 Vorsichtsmaßnahmen bei der Gerüst-/Systementfernung Abschnitt 7.2. Mögliche Komplikationen. Gerüstapplikationssystem verwendet dasselbe Funktionsprinzip und dieselben Materialien wie
• Entfernung des Gerüstapplikationssystems vor der Gerüstentfaltung 7.2 Mögliche Komplikationen andere Abbott Vascular RX-Stent-/Gerüstsysteme und Koronar-Dilatationskatheter.
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5. Das rotierende Hämostaseventil festziehen. • Transfusionsbedürftige • Restenose des gerüstgestützten von ≥ 1. Primäre angiographische Ausschlusskriterien umfassten: Aorto-ostiale Lage; Lage
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° Dauefn n Beaultlroanl secrnheaultte na.uf Nenndruck inflatieren, dann deflatieren und den Druck •• KKoorroonnaarraarrtteerriieenns- poadsemr uGse rüstembolie •• TInostatalvbeilres cohdleurs sst adbeirl eK Aornogninaara rpteecriteoris BÜebheralanpdpluunnggs vsotrna tAebgsieo:r bD BieV VSo wrdailra tnaitciohnt edrelaru Zbite.l lEäisnieo nN wotaimr opblalingtaattoiornis cmhu. sEsintee mgeitp lante
• 2EAvoi)pn np NlKiSGGwkiocoaeee°mhtlrrrl iüütdtobpessenD eottnns aifnez,oasp eu clydpvgn shaolietirt eskrnegdhna m eege dtimndero ieikedsgn saseaeesen irmnsAnrfny oept SSselzmpgcctu lerShhi mekmZrryiaiice sttstVtthitiee oteeeop nrmu1ndulsun en Zbssdarkuyi tl/s dtssroo üe tw5ddeEcse eämik wrnNrhz shiAriazee eeuucdfhnüirsheted h üdrBne rhbid eenlodaeesntltensfec.aes nhtvZr i.äoBnoudnenariüsnl glücbo.ubkannzelsgliro e mvndhoseäem snßW si gGe ieddenmeertfüsra ss Dltttesarut neucdnnk d sa/puoüfd redbraa sr •••••• KTDDoNcFoihdooiiessdiertbrstof ruaeae nrlTrlkeglamht iriEsraoäocmrnßmth ebidegrboreieeo lrriEns s Kio-eine od)ogrreurdorinefn fngra i Grc(aLheruttr eüfntrs,oi etGttfhaerlwolmmeäbbßeoi gsee r ••• VaGkVKTGaönaeaeecn nsmffdäähkntremßßyueirkkrdln äeeuaEisrrplrieäfsndal rietirmKeeraki ottmtAtuimsorresrn phretnleyrik fltluoahenrt,mid dodei neivreenlei nc,en ,hiet nr eiinemkin suasclcächhrhleieelrineß ßliclichh EEwBD7eünibiin2eanecnet hurehesSrdea tcltS Nearnuhvtnpäodhene,pttrleid tiduefdimregüuannineugppndg nblgiedv aegamm oen drsmnr ti ed awt Xd siGottTIaie EoseKhTrm,iNnrs rhaüm o C rrmsIvodmnEutomiiad ostbnV belsbdo om xtCoeSzgevymlzet eeoeetysrnep nitfsAn eanitüud bnhaCgbnoasrgeeggYeoggerenrPrglreianb,gHer ls e-angEeBBsgbeanRVeiatestten®Sitsruoir, po nlnwSfdLrnaiasicuäasrtchonhr rh≥hf egltetni eemm esmi3n c pjumd.0emhäsud0tet e-reo eercrmrcnrnlh luha:a gg ie lue Psenrurbfh ruenü1otar.ndhb lSdDmt raeAtetin nuierswtd n pShBNeediatnarraeedit,lcn tnl eoenhd tn≥nna dive,,sc i e l3u hmabrdn0 twiuadusd0treehs icownmmsehndtreeg g eVknwne teene f awü6irr ndhrfh ae ebiadrerh tildesst reeree nnnr ..
• Falls es notwendig ist, den Führungsdraht für nachfolgende Zugänge zur Arterie • Hypotonie/Hypertonie Während der Gerüstimplantation mussten alle Patienten gemäß dem Versorgungsstandard
bzw. Läsion zu verwenden, den Führungsdraht liegen lassen, während alle anderen des klinischen Zentrums eine Antikoagulantien- oder andere gerinnungshemmende
Systemkomponenten entfernt werden. Behandlung erhalten. Alle Patienten mussten mindestens 6 Monate täglich Clopidogrel-
6.5 Vorsichtsmaßnahmen nach der Implantation Bisulfat 75 mg und für die restliche Dauer der klinischen Studie (5 Jahre) Aspirin ≥ 75 mg
• Falls ein Durchqueren eines neu entfalteten Gerüsts mit einem Führungsdraht, Ballon, 1 Certican® UK-Produktbeschriftung November 2014
Applikationssystem oder bildgebenden Katheter notwendig ist, vorsichtig vorgehen,
damit die Gerüstgeometrie nicht beeinträchtigt wird. 2 Afinitor® EU-Zulassung Fachinformation Dezember 2014
• Nach dem Eingriff sollten Thrombozytenaggregationshemmer verabreicht werden 3 Votubia® EU Fachinformation September 2014
(siehe Abschnitt 9.1 Individualisierung der Behandlung). 4 Afinitor® US-Produktbeschriftung Dezember 2014
5 Zortress® US-Produktbeschriftung Februar 2013
Siehe www.MHRA.gov.uk, www.ema.europa.eu und www.fda.gov für die neuesten Versionen
dieser Fachinformationen/Produktbeschriftungen.
EL2105973 (2015-08-27)
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