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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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January 26, 2015
08:34 EDTEWEdwards Lifesciences should be bought on strong TAVR data, says Wells Fargo
Wells Fargo commends buying shares of Edwards Lifesciences after the firm viewed the most recent Transcatheter Valve Therapies registry update and estimated that the TAVR market may have grown 20% sequentially last quarter, versus its previous estimate of 1% sequential growth. The firm keeps an Outperform rating on Edwards.
07:17 EDTEWSociety of Thoracic Surgeons to hold annual meeting
51st Annual Meeting of STS is being held in San Diego, California on January 24-28.

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