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news.Edwards Lifesciences has completed enrollment in the 350-patient non-surgical study arm of its US pivotal trial - known as the Partner trial - for the company's Sapien transcatheter aortic heart valve.
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The Partner trial is a randomized, controlled, multi-center study that assigns patients into one of two arms: a ‘non-surgical’ arm, in which the Edwards’s Sapien valve is compared to non-surgical treatments, and a ‘surgical’ arm, in which the Edwards’s Sapien valve is compared to traditional surgical aortic valve replacement.
The company also said that it plans to provide continued access at Partner study sites to the Edwards’s Sapien valve for non-surgical patients meeting study criteria, pending FDA approval.
Edwards said that it is the only company with a US investigational device exemption pivotal study underway for a transcatheter aortic valve replacement, and the only company to have both transfemoral and transapical transcatheter valve delivery systems commercially available in Europe.