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Dritte FDA-Zulassung für revolutionäres Simbionix-Produkt
Date:3/31/2013

n. Das virtuelle Modell kann dann für die Simulation, Analyse und Bewertung präoperativer chirurgischer Behandlungsoptionen vor Durchführung des eigentlichen Eingriffs genutzt werden und diesen so für den behandelnden Arzt erleichtern. Nach dem Export des 3D-Modells in die Simulationsumgebung von Simbionix ANGIO Mentor™, kann der Arzt den Eingriff unter Verwendung realitätsgetreuer Instrumente und Endografts mehrfach üben.

Die Society of Vascular Surgery (Gesellschaft für Gefäßchirurgie) schlägt als Voraussetzung für eine Zertifizierung die Durchführung von mindestens 100 Diagnosen, 50 Eingriffen und 10 TEVAR-Fällen vor. Mit dieser neuen innovativen Anwendung erhalten Mediziner eine praktische Schulung in TEVAR-Eingriffen, u. a. mit präziser Platzierung einzelner und multipler Stentgrafts und Anwendung des Ballonverfahrens, vor dem eigentlichen Eingriff am Patienten. Das PRS vereinfacht das Planungsverfahren und bietet eine umfassende Lösung für Schulung und Simulation patientenspezifischer Eingriffe. So werden die professionellen Fertigkeiten erfahrener sowie junger Ärzte ausgebaut.

Laut Dr. Yael Friedman , Leiter der Abteilung Regulatory Affairs bei Simbionix, ist die Erfolgsgeschichte des Unternehmens in der Bereitstellung innovativer Simulationstools für Gesundheitsfachkräfte die Basis für ein weiteres erfolgreiches Produkt. "Die Behandlung thorakaler endovaskulärer Aneurysmen ist eine der fortschrittlichsten Eingriffe, die Gefäßchirurgen vornehmen. Simbionix freut sich sehr über die FDA-Zulassung und ist stolz auf seine neue klinische PROcedure Rehearsal Studio TEVAR-Anwendung, die Ärzte bei der Analyse und Bewertung präoperativer chirurgischer Behandlungsoptionen unterstützt."

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SOURCE Simbionix USA Corporation
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