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IDEV gibt Ergebnisse von Studie zur Revaskularisation mit Supera an echten Patienten (RESTORE) bekannt - Studie demonstriert positive klinische Ergebnisse bei schwerkranken Patienten mit langen Läsionen
Date:2/1/2013

WEBSTER, Texas, 1. Februar 2013 /PRNewswire/ -- IDEV Technologies, Inc. gab heute Ergebnisse einer neuen Studie bekannt, die durch Ärzte aus Tucson, Arizona durchgeführt wurde. Die Ergebnisse wurden vergangene Woche beim LINC in Leipzig (Deutschland) präsentiert.  Die Daten stimmen mit zuvor veröffentlichten Ergebnissen für das Supera® Stent überein, die in anderen Studien erreicht wurden, sich jedoch auf Patienten mit peripheren Erkrankungen in einem fortgeschritteneren Stadium bezogen.

147 Patienten aus Tucson wurden bei der Auswertung berücksichtigt.  Untersucht wurden lange Läsionen, wobei die durchschnittliche Läsionenlänge der Erkrankungen der oberflächlichen Arteria femoralis und der Arteria poplitea 18,4 cm betrug. Diese wurde durch eine durchschnittliche Stentlänge von 19,7 cm behandelt.  Die Studie umfasste Patienten mit Typ-C- und Typ-D-Läsionen der TASC-II-Klassifikation (28 % bzw. 33 %).  Zusätzlich litten 35 % der Patienten unter Gewebeverlust und wurden mit Rutherford Becker als 5 und 6 klassifiziert; 53 % aller Patienten litten unter chronischen Komplettverschlüssen.  Die übergreifende primäre Durchgängigkeitsquote wurde durch den Duplex-Ultraschall gemessen und betrug bei der Nachsorgeuntersuchung nach einem Jahr 88 %.  In einer Untergruppenanalyse von 47 Patienten, die Nachsorge-Röntgenuntersuchungen erhielten, wurden keine Frakturen festgestellt.

„Unsere Studie umfasste Patienten, die schwer erkrankt waren", kommentiert John Pacanowski , M. D., Chief of Vascular Surgery, Tucson Medical Center. Basierend auf dem umfassenden Datenvolumen für Supera sowie den Ergebnissen unserer Studie, sind wir davon überzeugt, dass Supera
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SOURCE IDEV Technologies, Inc.
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