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WorldHeart Receives US Clinical Study Approval for the Levacor(TM) VAD
Date:8/20/2009

SALT LAKE CITY, Aug. 20 /PRNewswire-FirstCall/ -- ("WorldHeart") (Nasdaq: WHRT) - World Heart Corporation (WorldHeart) announced today that it has received FDA conditional approval to begin a bridge-to-transplant (BTT) study of the Levacor Ventricular Assist Device (VAD) at ten US centers.

The company is required to provide some additional information to the FDA within 45 days, but the study is permitted to begin upon receipt of clinical center Institutional Review Board (IRB) approvals. WorldHeart has been working closely with a number of clinicians and clinical sites that are interested in participating in the Levacor Study.

Center expansion beyond the initial ten sites will be based upon a supplemental IDE application and subsequent FDA approval. Study enrollment will involve approximately 200 subjects, with an opportunity to demonstrate statistical significance through a planned interim analysis at approximately 150 subjects.

"We are extremely pleased to reach this key milestone in the development and clinical implementation of the Levacor VAD," said Mr. J. Alex Martin, WorldHeart's President and CEO. "We are also pleased that the clinical study has been assigned CMS category B2, which makes insurance reimbursement possible. Finally, we believe that our unique assist technology will provide life-saving potential for many heart-failure patients and further advance mechanical circulatory support therapy."

The Levacor VAD is the only bearingless, fully magnetically levitated, implantable centrifugal pump to enter clinical trials. The pump uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing. As described by Mr. Jal S. Jassawalla, World
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SOURCE World Heart Corporation
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