Canadian Study Prompts Edwards To Rethink PVT Feasibility Trial
This article was originally published in The Gray Sheet
Executive Summary
Edwards Lifesciences intends to resume a U.S. PVT percutaneous aortic valve feasibility trial by year-end
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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...
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...
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