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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.
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.
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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