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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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May 20, 2015
05:30 EDTEWEdwards Lifesciences announces outcomes for patients treated with SAPIEN 3 valve
Edwards Lifesciences announced that 30-day outcomes for intermediate-risk patients treated transfemorally with the SAPIEN 3 transcatheter aortic valve at centers in Europe and Canada demonstrated very low mortality and stroke rates, and no severe paravalvular leaks. These independently adjudicated data are consistent with the outcomes recently reported in a similar study of 1,000 patients treated at 51 centers in the United States. In the multi-center study of 101 intermediate-risk patients, all-cause mortality was 1 percent. The frequency of other important complications was also low: the disabling stroke rate was 2 percent, major vascular complications were 2 percent and the permanent pacemaker rate was 4 percent. The investigators also noted that the SAPIEN 3 valve had excellent hemodynamic performance, with very low incidence of significant paravalvular regurgitation, as only 2.3 percent of patients had moderate paravalvular leaks and there were no reports of severe leaks.
May 19, 2015
09:21 EDTEWEdwards Lifesciences voluntarily pauses enrollment for Fortis clinical program
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08:48 EDTEWEdwards Lifesciences reports positive results from treatment with SAPIEN 3
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May 12, 2015
10:01 EDTEWOn The Fly: Analyst Upgrade Summary
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06:48 EDTEWEdwards Lifesciences upgraded to Overweight from Neutral at JPMorgan
JPMorgan upgraded Edwards Lifesciences to Overweight following the 15% selloff since mid-March. The firm says its confidence in the conversion of the surgical valve replacement market to transcatheter replacement increased significantly at this year's ACC. It adds that its recent field work indicates the TAVR market has accelerated post-ACC. JPMorgan raised its price target for shares to $155 from $147.
06:35 EDTEWEdwards Lifesciences upgraded to Overweight from Neutral at JPMorgan

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