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MiStent SES erweist sich im klinischen Umfeld als einzigartig
Date:10/28/2013

an Tieren haben ergeben, dass sich die Beschichtung in 45 bis 60 Tagen vom Stent löst, sodass ein reiner Metall-Stent zurückbleibt. Das Polymer wird innerhalb von 90 Tagen vollständig vom umgebenden Gewebe absorbiert und stärkt die langfristige Durchgängigkeit und Kompatibilität mit der Arterie.

Im Juni 2013 erhielt Micell die CE-Zulassung (Conformite Europeenne) der europäischen Wirtschaftsunion für das MiStent SES. In den Vereinigten Staaten und anderen Ländern ist das System jedoch nicht zugelassen. Eine zweijährige Nachbeobachtung der Probanden aus den klinischen Studien DESSOLVE I und II wurde 2013 abgeschlossen und eine langfristige Folgestudie an denselben Patienten läuft noch.

Informationen zu den Studien DESSOLVE I und DESSOLVE II

Im Rahmen der Studie DESSOLVE I, der ersten klinischen Untersuchung der Sicherheit und Wirksamkeit des MiStent SES®, sind dreißig Patienten mit de-novo-Läsionen in Koronararterien mit einem Durchmesser von 2,5 bis 3,5 mm behandelt worden, für die eine Behandlung mit einem Stent mit einer maximalen Länge von 23 mm infrage kam. Die Probanden stammten aus fünf verschiedenen Studienzentren in Neuseeland, Australien und Belgien. Drei unabhängige Untergruppen mit jeweils 10 Patienten wurden mittels Angiografie, IVUS und OCT zu drei verschiedenen Zeitpunkten bewertet: nach vier, sechs und acht Monaten. Der primäre Wirksamkeitsendpunkt war der späte In-Stent-Lumenverlust. Zu jedem der genannten Zeitpunkte wurde die Sicherheit auf Basis der MACE-Inzidenz und anhand der Abdeckung der Stützstrebe mit Gewebe in der behandelten Arterie überprüft. Dr. med. William Wijns, Ph.D., vom Herz- und Gefäßzentrum im belgischen Aalst und John Ormiston, M.B.Ch.B., von der Mercy Angiography Unit in Auckland (Neuseeland) sind Co-Fo
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SOURCE Micell Technologies
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