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News Breaks
February 5, 2014
09:20 EDTEWEdwards Lifesciences' SAPIEN XT valve approved in EU
Edwards Lifesciences announced it has received CE Mark in Europe for valve-in-valve procedures using the SAPIEN XT transcatheter heart valve, providing a minimally invasive treatment option for patients whose surgical mitral or aortic valves require replacement, and who are at extreme risk for surgery. Edwards is the only company to receive a valve-in-valve indication for the mitral position, which addresses an unmet need within the clinical community to provide an alternative to a high-risk surgery.
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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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