edwards lifesciences corp (EW) Key Developments
Edwards Lifesciences Corp. Presents at Piper Jaffray Heartland Summit, Jun-23-2015
Jun 19 15
Edwards Lifesciences Corp. Presents at Piper Jaffray Heartland Summit, Jun-23-2015 . Venue: Minneapolis, Minnesota, United States. Speakers: Michael A. Mussallem, Chairman and Chief Executive Officer.
Edwards Receives FDA Approval for Sapien 3 Transcatheter Heart Valve
Jun 17 15
Edwards Lifesciences Corporation announced U.S. Food and Drug Administration (FDA) approval of its most advanced transcatheter aortic heart valve the Edwards SAPIEN 3 valve with the Commander Delivery System for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis. The PARTNER II study concluded that this new valve reduced several complications associated with the TAVR procedure such as paravalvular leakage and stroke, and represented a meaningful improvement over data from prior studies with earlier-generation devices. SAPIEN 3 approval was based on a cohort of the PARTNER II Trial, which enrolled 583 high-risk patients at 29 U.S. sites. The SAPIEN 3 valve builds on Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves. The new valve, available in 20mm, 23mm, 26mm and 29mm sizes, has an outer skirt a cuff of fabric surrounding the valve frame providing a seal to address paravalvular leak.
Edwards Lifesciences Corporation Announces Encouraging Results from Aortic Stenosis Study
Jun 4 15
Edwards Lifesciences Corporation has announced that patients with aortic stenosis who received Edwards SAPIEN 3 transcatheter aortic valve via transfemoral delivery had a one-year survival rate of 91.6%, as well as low rates of stroke and paravalvular leak. The independently adjudicated data from the CE Mark study were presented. Among the outcomes reported from the study, transfemoral SAPIEN 3 transcatheter aortic valve replacement (TAVR) was associated with a disabling stroke rate of 1.1%. In addition, only 2% of patients had moderate paravalvular leaks and there were no reports of severe leaks. There were also no observations of structural valve deterioration. "The one-year survival rate in the transfemoral cohort is the high reported in a multicenter, fully adjudicated TAVR study to date. These results set a new standard of care for patients at high risk for surgical aortic valve replacement. The results of the SAPIEN 3 trial via the transfemoral approach also raise the question of whether transcatheter valve replacement should be considered for approval for all elderly patients with severe aortic stenosis’. The SAPIEN 3 Trial is a prospective, multicenter, non-randomized study. The one-year analysis documented outcomes of the first 150 patients treated with the SAPIEN 3 valve between Jan. 2013 and Nov. 2013 at 16 centers in Europe and Canada. Access approaches included transfemoral (n=96) and transapical/transaortic (n=54), as determined by the Heart Team. At baseline, the patients in the alternative access group were significantly sicker than the transfemoral group. All-cause mortality in the alternative access group was reported as 24.3% in the as-treated population. The SAPIEN 3 Trial is designed to evaluate patients annually for five years. The SAPIEN 3 valve can be delivered through a low-profile 14 French expandable sheath (eSheath). It also has an outer skirt - a cuff of fabric that provides a seal at the bottom of the frame that is designed to reduce paravalvular aortic regurgitation.
Edwards Lifesciences Corp. Presents at Goldman Sachs 36th Annual Global Healthcare Conference, Jun-10-2015 02:00 PM
May 16 15
Edwards Lifesciences Corp. Presents at Goldman Sachs 36th Annual Global Healthcare Conference, Jun-10-2015 02:00 PM. Venue: Terranea Resort, Rancho Palos Verdes, California, United States. Speakers: Scott B. Ullem, Chief Financial Officer and Corporate Vice President.
Edwards Lifesciences Corp. - Shareholder/Analyst Call
May 7 15
Annual Meeting Of Stockholders