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.
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.
"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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