Early results "encouraging" for Edwards' redesigned Sapien XT valve

March 10, 2013 by Arezu Sarvestani

Edwards Lifesciences' redesigned Sapien XT transcatheter aortic valve implantation system demonstrates non-inferiority to the original Sapien device, according to results unveiled at the American College of Cardiology conference in San Francisco.

Edwards Lifesciences' Sapien and Sapien XT valves

Edwards Lifesciences' original Sapien (left) and new Sapien XT (right) valves.

Medical device maker Edwards Lifesciences (NYSE:EW) unveiled results from the 1st randomized study of its Sapien XT transcatheter aortic valve replacement system, reporting non-significant improvements in safety when compared with the original Sapien system.

The PARTNER II trial's Cohort B was designed to demonstrate that the Sapien XT was at least non-inferior to Sapien classic in terms of safety and efficacy in treating patients too sick to undergo open-heart surgery. The study was a win in that regard, with many of the short- and long-term outcomes of the devices falling along similar lines.

At 30 days all-cause mortality for the Sapien XT was 3.5%, compared to 5.1% for the original Sapien valve, according to Edwards. Although the findings missed the mark for statistical significance, it was a victory for the Sapien line.

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"These are the lowest 30-day mortality results for transcatheter aortic valve replacement in any study using rigorous clinical trial methodology," co-principal investigator Dr. Martin Leon said in prepared remarks. "For these inoperable patients, the sickest of the sick, they're surprisingly good."

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