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Thoratec Announces Unanimous FDA Advisory Panel Recommendation for Approval of HeartMate II(R) for Bridge-to-Transplantation
Date:11/30/2007

PLEASANTON, Calif., Nov. 30 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, said today that the FDA Circulatory System Devices Advisory Panel has recommended unanimously that the agency approve, with conditions, the company's PMA (PreMarket Approval) allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) as a bridge-to-transplantation (BTT).

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

"We are delighted with the panel's recommendation indicating their belief that the data demonstrate the safety and efficacy of the device. This represents a major step in our program to make this state-of-the-art circulatory support technology commercially available in the U.S. for patients suffering from advanced-stage heart failure," said Gary F. Burbach, president and chief executive officer of Thoratec. "We believe the data reflect the positive experience of patients in the trial and that the HeartMate II represents a significant breakthrough in the treatment of heart failure and look forward to continuing what has been to date a positive dialogue with the FDA around this submission and achieving approval," he added.

The leading clinical presenters were Dr. Leslie Miller, Walters Chair of Cardiovascular Medicine and Director of Cardiology Programs at Washington Hospital Center & Georgetown University Hospital, and Dr. Francis Pagani, Director, Heart Transplant Program, University of Michigan Hospital.

The conditions outlined in the panel's recommendations related to clarifications on labeling for the device regarding small patients a
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SOURCE Thoratec Corporation
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