Cardiology

WorldHeart Submits IDE Application for a Pivotal Bridge-to-Transplant Study of the Levacor(TM) VAD

Published in Medical Letter on the CDC and FDA, January 25th, 2009

(NASDAQ:WHRT) World Heart Corporation ("WorldHeart") announced that it has submitted an Investigational Device Exemption ("IDE") application to the US Food and Drug Administration ("FDA" or the "Agency") for a pivotal Bridge-to-Transplant ("BTT") study of the Levacor(TM) Ventricular Assist Device ("VAD").

The IDE application includes detailed device information, including design and in vitro and in vivo preclinical testing protocols and results. The submission also encompasses an Investigational Plan and extensive study-related materials. The Levacor VAD is intended for use, inside and outside of the hospital, as a BTT in cardiac transplant candidates with presumed...

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Source: Medical Letter on the CDC and FDA (2009-01-25)

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