World Heart Corporation

FDA Circulatory System Devices Panel to review Novacor LVAS PMA application

Published in Law and Health Weekly, May 29th, 2004

World Heart Corporation (WHRT) announced that the corporation's Premarket Approval (PMA) application for an expansion to the current indication for use of the Novacor LVAS (left ventricular assist system) will be reviewed at the meeting of the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) to be held on June 8, 2004.

The PMA application requests an expansion of the bridge to transplant (BTT) indication for use of the Novacor LVAS to include certain heart failure patients who are not listed for transplant due to contraindications that may resolve with LVAS support.

The application, which was originally submitted to the...

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Source: Law and Health Weekly (2004-05-29)

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