Updated: Added new FDA approval information on the Sapien XT
The low rate of complications seen with the next-generation Sapien 3 replacement heart valve made by Edwards Lifesciences (NYSE:EW) at 30 days persisted for a full year, researchers said today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco.
The company also announced its Sapien XT Transcatheter heart valve won FDA approval at the conference.
One-year data from Irvine, Calif.-based Edwards’ Partner II trial, which enrolled 583 high-risk or inoperable aortic stenosis patients for implantation with the Sapien 3 transcatheter aortic valve implant, showed a follow-up rate at 1 year of 98.6% and an all-cause survival rate of 85.6%. The rate of disabling stokes at 1 year was 2.4%, with no difference between the high-risk and inoperable cohorts, or between devices delivered transfemorally or transapically.
Paravalvular regurgitation rates were 2.7% for moderate regurgitation and 29.1% for mild regurgitation, with no increased mortality in patients with mild regurgitation; there was no incidence of severe regurgitation.
“The combination of new design features, procedural improvements, operator experience, and improved patient selection have all contributed to a low rate of adverse events and a high rate of 1-year survival in TAVI for high-risk and inoperable patients with severe aortic stenosis,” study investigator Dr. Howard Herrmann, of the Perelman School of Medicine at the University of Pennsylvania, said in prepared remarks. “This represents a 50% reduction in mortality in both [high-risk] and [inoperable] patients as compared with the 1st-generation TAVI device.
“This one-year follow-up data support the use of TAVR as the preferred therapy in high-risk and inoperable patients with aortic stenosis,” Herrmann said.
Edwards said its Sapien xT transcatheter heart valve won FDA pre-market approval for aortic valve-in-valve procedures.
“U.S. approval of the valve-in-valve procedure provides an important minimally invasive treatment option for patients who are at high risk for a subsequent open-heart surgery to replace their bioprosthetic valves,” transcatheter heart valves prez Larry Woods said in a press release.
