World Heart Corp

FDA approves reliability label revision for Novacor LVAS

Published in Lab Business Week, August 29th, 2004

World Heart Corp. (WHRT) announced that the U.S. Food and Drug Administration (FDA) has approved a premarket approval supplement application for a revision to the labeling of the Novacor LVAS (left ventricular assist system) to reflect the current device reliability data available to patients and physicians.

Notable in the revised labeling is the demonstrated performance longevity of the Novacor LVAS, which encompasses implant duration from 0 to more than 36 months.

The revised labeling, which is based upon statistical analysis of 1077 device implants, shows the chance for re-operation to either fix or replace the Novacor LVAS is 1.6% between 0 and 6...

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Source: Lab Business Week (2004-08-29)

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