Boston, MA 06/18/2014 (wallstreetpr) – Edwards Lifesciences Corporation (NYSE:EW) on June 16, 2014 announced receiving approval from the United States Food and Drug Administration (FDA) for Edwards SAPIEN XT transcatheter aortic heart valve. This will be used in the treatment of inoperable and high-risk patients who suffer from chronic symptomatic aortic stenosis (AS).
Edwards SAPIEN XT Transcatheter Aortic Heart Valve
The newly-approved Edwards SAPIEN XT transcatheter aortic heart valve is the next-gen and low-profile system which encompasses 29mm valve size for those patients who have large native annulus. This system allows for the treatment of a range of patients.
The Edwards Lifesciences Corporation (NYSE:EW) SAPIEN XT transcatheter aortic heart valve will be made accessible quickly to the patients through the nation’s leading cardiovascular centers. This will be made available with NovaFlex+ transfemoral delivery system, which will be delivered via low-profile 16-French expandable sheath, also called eSheath as well as transaortic and Ascendra+ transapical delivery systems.
The Edwards SAPIEN XT valve is already commercially available since the year 2010 in Europe. In the year 2013, it received regulatory and reimbursement approval in Japan as well.
Statement from the MD, director, Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Centre
The MD, director, Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Centre, Martin B. Leon said that there is a huge possibility of evidence that SAPIEN XT valve will not only benefit the high-risk patients but also those patients who were regarded inoperable. He added that the clinicians had documented the positive results in European country registries as well as randomised studies.
Martin B. Leon further said that the results from PARTNER II Trial in treatment of inoperable patients with SAPIEN XT valve proved the reduction in complication that may arise with TAVR procedure.
Statement From The Corporate Vice President, Transcatheter Heart Valves, Edwards
The corporate vice president, transcatheter heart valves, Edwards, Larry L. Wood said that the valves from the SAPIEN family have already been involved in the treatment of over 70000 patients across the world. Most of the patients, he added, have been treated by making use of SAPIEN XT.
