Rochester, NY 8/20/2009 11:36:37 PM
World Heart Corp. WHRT - WorldHeart Announces its Levacor Study
World Heart Corp. WHRT
World Heart Corporation announced today that it has received FDA conditional approval to begin a bridge-to-transplant study of the Levacor Ventricular Assist Device 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 approvals.
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"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."
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