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Published on 5/16/2006 in the Prospect News Biotech Daily.

Thoratec to add 90 patients in HeartMate trial

By Elaine Rigoli

Tampa, Fla., May 16 - Thoratec Corp. said the Food and Drug Administration has approved an Investigational Device Exemption supplement that allows enrollment of up to an additional 90 patients in the bridge-to-transplantation arm of the company's HeartMate 2 phase 2 trial under a continued-access protocol.

The HeartMate 2 is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart-failure patients.

The original trial design for the bridge-to-transplantation arm called for enrollment of 133 patients. As of April 26, the company reported that 115 patients had been enrolled in the bridge-to-transplantation arm of the study.

Based in Pleasanton, Calif., Thoratec develops products to treat cardiovascular disease.


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