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invendo medical gibt Markteinführung für computergestütztes Koloskopiesystem zur einmaligen Verwendung nach spezieller 510(k)-Freigabe durch die US-Arzneimittelbehörde FDA bekannt
Date:3/11/2013

NEW YORK und KISSING, Deutschland, 11. März 2013 /PRNewswire/ -- invendo medical hat heute bekannt gegeben, dass das Unternehmen durch Installation erster Systeme im NYU Langone Medical Center und dem New York-Presbyterian Hospital/Columbia University Medical Center - zwei GI-Endoskopiezentren von erstklassigem Ruf - den US-Markt betreten hat. Die ersten US-Patienten wurden bereits einer Koloskopie mit dem neuen Koloskopiesystem C20™ unterzogen, das über das Koloskop SC20™ zur einmaligen Verwendung verfügt.

(Logo: http://photos.prnewswire.com/prnh/20130311/NY73775LOGO )

Dieser Ersteintritt in den US-Markt folgt auf eine spezielle Freigabe im Rahmen eines 510(k)-Verfahrens durch die amerikanische Arzneimittelbehörde FDA, welche die Freigabe für die Vermarktung mehrerer wichtiger Produktverbesserungen erteilte.

Das invendoscope™ SC20 verfügt über mehrere Funktionen, die im Bereich der Koloskopie neu sind:

  • Es handelt sich um ein Koloskop zur einmaligen Verwendung mit Arbeitskanal.
  • Das Koloskop wird nicht manuell geschoben oder gezogen, sondern durch eine computergestützte (robotische), sanfte Antriebstechnik bewegt.
  • Alle endoskopischen Funktionen werden mithilfe eines Handgeräts ausgeführt.
  • Der auf die Dickdarmwand ausgeübte Druck wird reduziert.

„Wir sind stolz darauf, dass zwei derart angesehene klinische Institutionen sich dafür entschieden haben, ihren Patienten eine zusätzliche Option für die Koloskopie zu geben", sagte John J. Cifarelli , Leitender Vizepräsident (EVP) für Global Markets bei invendo medical. „Wir waren in Bezug auf das Potenzial unseres neuen Koloskopiesystems höchst
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SOURCE invendo medical
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