Edwards Lifesciences Corporation, a global leader in the science of heart valves and hemodynamic monitoring, has received US Food and Drug Administration (FDA) approval for aortic valve-in-valve procedures using the Edwards Sapien XT transcatheter heart valve.
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At the 27th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in San Francisco, one-year patient outcomes were presented for patients treated with transcatheter Sapien XT valve implantation in surgical tissue valves. The valve-in-valve procedure was associated with a high overall one-year survival rate of 86.6 per cent and a low overall stroke rate of 3.7 per cent in a very high-risk patient population, according to independently adjudicated data from the 197-patient PARTNER II Valve-in-Valve study. The study, which is a multicenter, non-randomized cohort of The PARTNER II Trial, included 97 patients enrolled in the primary registry as well as 100 continued access patients.
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The Edwards Sapien XT valve was approved by the FDA in June 2014 for patients at high risk for native aortic valve replacement surgery, and received CE Mark for valve-in-valve procedures in early 2014. The Sapien valve platform has been used in the treatment of more than 100,000 patients worldwide.
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