|Edwards submitted application for FDA review of new heart valve.|
|By BioMedReports.com Staff|
|Tuesday, 07 June 2011 19:08|
Edwards Lifesciences Corp (NYSE:EW) said a U.S. regulatory advisory panel will review its application on July 20 to sell the Sapien aortic heart valve that spares patients the need for open-heart surgery.
Edwards submitted its application to the U.S. Food and Drug Administration last fall based on data from the Cohort B portion of its Partner clinical trial for patients with severe aortic stenosis, a narrowing of the valve, who are considered too sick for open-heart surgery.
If approved, the Edwards valve would be the first so-called trans-catheter aortic valve sold in the United States. Edwards has been selling such a valve in Europe since 2007.
Wells Fargo Securities analyst Larry Biegelsen said the Edwards valve appears on track for a U.S. launch in the fourth quarter of this year.
He said he expects an FDA panel to review Cohort A data from the Partner trial late this year or in early 2012.
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Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that a U.S. Food and Drug Administration (FDA) Advisory Panel is scheduled to review the company's Premarket Approval (PMA) application for its Edwards SAPIEN transcatheter heart valve on July 20, 2011.
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