FDAnews Device Daily Bulletin

THORATEC RECEIVES FDA APPROVAL OF CONTINUED ACCESS PROTOCOL FOR BRIDGE ARM OF ITS HEARTMATE(R) II PIVOTAL TRIAL

May 18, 2006
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Thoratec Corporation, a world leader in products to treat cardiovascular disease, today said that the FDA has approved an IDE (Investigational Device Exemption) supplement that allows enrollment of up to an additional 90 patients in the Bridge-to-Transplantation (BTT) arm of the company's HeartMate II Phase II trial under a Continued Access Protocol (CAP).
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