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Artikel im American Journal of Cardiology zeigt gute Gefäßheilung nach MiStent-SES-Implantation
Date:11/21/2013

tentsystems, ein modernster blanker Metallstent, der sich durch ausgezeichnete Platzierbarkeit, Formanpassungsfähigkeit und Flexibilität bewährt hat.

Ergebnisse aus Tierstudien haben gezeigt, dass sich die Beschichtung nach 45 bis 60 Tagen abgelöst hat und ein blanker Metallstent übrig bleibt. Das Polymer wird innerhalb von 90 Tagen vollständig in das umliegende Gewebe resorbiert, was sich positiv auf die lang anhaltende Durchlässigkeit und Kompatibilität mit der Arterie auswirkt.

Micell erhielt im Juni 2013 von der Europäischen Wirtschaftsunion das CE-Zeichen (Conformite Europeenne) für MiStent SES. Das Produkt ist aber weder in den USA noch in anderen Ländern zugelassen. 2013 wurde ein Zwei-Jahres-Followup der klinischen DESSOLVE-I- und -II-Studie abgeschlossen. Die Teilnehmer werden derzeit im Rahmen eines Langzeit-Followup beobachtet.

Informationen zur DESSOLVE-I- und DESSOLVE-II-Studie

Die DESSOLVE-I-Studie war die erste klinische Untersuchung der Sicherheit und Wirksamkeit des MiStent SES®. Dabei wurden dreißig Patienten mit De-novo-Läsionen in den Koronararterien mit einem Durchmesser zwischen 2,5 und 3,5 mm behandelt, die für die Behandlung mit einem Stent mit einer maximalen Länge von 23 mm geeignet waren. Die Studie wurde an fünf Prüfzentren in Neuseeland, Australien und Belgien durchgeführt. Drei unabhängige Teilgruppen von jeweils 10 Patienten wurden mittels Angiografie, IVUS und OCT zu drei Zeitpunkten evaluiert: nach vier, sechs und acht Monaten. Der primäre Endpunkt bezüglich der Wirksamkeit war der späte In-Stent-Lumenverlust. Die Sicherheit wurde anhand der Inzidenz von MACE und der vorhandenen Strut-Gewebeabdeckung innerhalb der behandelten Arterie zu jedem Zeitpunkt beurteilt. William Wijns, M.D., Ph.D., Cardiovascular Center in Aalst, Belgien, und '/>"/>

SOURCE Micell Technologies, Inc.
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