Edwards Lifesciences Corp. (EW: Quote), Sunday said that results from a study demonstrated similar results in mortality and major clinical events between the Edwards’ Sapien XT transcatheter aortic valve and the Edwards Sapien valve.
The trial called Partner II was studying transcatheter aortic valve replacement in inoperable patients with severe, symptomatic aortic stenosis.
The Partner II trial enrolled 560 patients deemed inoperable for traditional open-heart surgery at 28 hospitals in the US between April 2011 and February 2012. Patients were randomized to receive one of the two Edwards transcatheter aortic heart valves: 276 received the SAPIEN valve, and 284 received the Sapien XT valve.
The FDA approved the Sapien valve in November 2011 for the treatment of inoperable patients, and expanded the indication to high-risk surgical patients in October 2012. The Sapien XT valve is an investigational device not yet available commercially in the US.
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by RTT Staff Writer
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