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WorldHeart

This article was originally published in The Gray Sheet

Executive Summary

PMA supplement covering Novacor left ventricular assist system as an alternative to transplant for end-stage heart failure patients is submitted to FDA, firm reports Aug. 15. WorldHeart has requested that the agency grant it expedited review. A total of 270 patients have received the Novacor in North American clinical trials, in addition to 1,349 implants under the existing "bridge-to-transplant" indication (11"The Gray Sheet" June 17, 2002, p. 36)...
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