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News Breaks
January 27, 2014
09:16 EDTEWEdwards receives CE Mark for advances SAPIEN 3 value
Edwards Lifesciences announced that it has received CE Mark in Europe and is initiating the launch of its most advanced transcatheter aortic valve, the Edwards SAPIEN 3 valve. The SAPIEN 3 valve builds upon Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves. The new valve has an outer skirt -- a cuff of fabric surrounding the valve frame -- providing a seal to address paravalvular leak. The effectiveness of this solution is supported by the limited clinical experience, as detailed in two first-in-human feasibility studies, which demonstrated that significant paravalvular leak was eliminated during transcatheter aortic valve implantation. The SAPIEN 3 valve is the only commercial transcatheter heart valve that can be delivered through a low-profile 14 French expandable sheath, which has shown through early clinical experience a low rate of complications. The valve can be implanted through multiple approaches: transfemoral, transapical or transaortic. Once implanted, the discreet valve anchors in the aortic annulus. In the United States, the Edwards SAPIEN 3 valve is an investigational device being studied in the PARTNER II Trial and is not yet available for sale in the country.
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March 24, 2015
10:08 EDTEWSenate Health, Education, Labor & Pensions Committee to hold a hearing
The Committee holds a hearing entitled, "Continuing America’s Leadership: Advancing Research and Development for Patients" with Chairman & CEO Mussallem of Edwards Lifesciences on March 24 at 10 am. Webcast Link
March 20, 2015
16:33 EDTEWStocks end week higher after market reads Fed statement as dovish
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