Edwards Foresees Percutaneous Heart Valve Replacement Milestones In 2006
This article was originally published in The Gray Sheet
Executive Summary
Edwards Lifesciences expects to complete enrollment in the U.S. feasibility study for its Cribier-Edwards minimally invasive aortic heart valve during the first half of 2006
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Percutaneous Heart Valves May Demand Novel Regulatory Approach
Leading innovators hope to blaze a trail through what some see as formidable regulatory barriers to technological advances allowing diseased aortic valves to be replaced percutaneously
Percutaneous Heart Valves May Demand Novel Regulatory Approach
Leading innovators hope to blaze a trail through what some see as formidable regulatory barriers to technological advances allowing diseased aortic valves to be replaced percutaneously
Edwards percutaneous valve
Edwards Lifesciences will resume the 20-patient non-randomized feasibility trial of its Cribier-Edwards percutaneous aortic heart valve at three sites, the company announced Dec. 1. Edwards first started the trial in January, but stopped it in June after discovering a new retrograde delivery approach, which involves passing the valve on a catheter through the femoral vein, across the mitral valve, and into the aortic valve - a safer and simpler approach than the antegrade approach investigators had been using (1"The Gray Sheet" June 20, 2005, p. 17). The new trial will also include a larger 26 mm valve. Cases will commence upon investigational review board approval...