SAPIEN 3 Valve Demonstrates Low Mortality, Excellent 30-Day Outcomes In High- And Intermediate-Risk Patients

SAN DIEGO -- Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that 30-day outcomes for high- and intermediate-risk patients treated with the SAPIEN 3 transcatheter aortic valve demonstrated the lowest all-cause mortality rates of any of the PARTNER studies, as well as excellent clinical outcomes on the other components of the primary endpoint measures of stroke and paravalvular regurgitation. This first report of SAPIEN 3 data in the United States, and first report on intermediate risk transcatheter aortic valve replacement (TAVR) patients, was presented as part of the late-breaking clinical trials at the American College of Cardiology's (ACC) 64th Annual Scientific Session in San Diego.

"These results of more than 1,600 patients treated with the SAPIEN 3 valve demonstrate the most significant progress in the development of TAVR and the SAPIEN family of valves since the first PARTNER study was initiated in 2007," said Susheel Kodali, M.D., director, Heart Valve Program, at NewYork-Presbyterian/Columbia University Medical Center and assistant professor of medicine at the Columbia University College of Physicians and Surgeons. Kodali is the co-principal investigator for the SAPIEN 3 studies. "With average ages in the 80s, the high-risk and intermediate-risk patients in the study had strikingly low mortality rates of 2.2 and 1.1, respectively, despite predicted 30-day mortality that was much higher. Additionally, the rates of significant paravalvular leaks were low in both cohorts – 3.0 for high-risk and 4.2 for intermediate – which represented meaningful improvements over prior studies with earlier generation devices."

The SAPIEN 3 high-risk cohort enrolled 583 patients at 29 U.S. sites; the intermediate risk cohort enrolled 1,076 patients at 51 U.S. sites. Both studies were single-arm, non-randomized cohorts of the PARTNER II Trial. Important clinical measures from the studies are presented in the table below.

The SAPIEN 3 valve is Edwards' most advanced transcatheter aortic valve, and can be delivered through a low-profile 14 French expandable sheath (eSheath). It also has an outer skirt – a cuff of fabric surrounding the bottom of the frame – to provide a seal to minimize paravalvular leak. The SAPIEN 3 valve can be implanted via the transfemoral approach through an incision in the leg, as well as alternative access approaches.

The SAPIEN 3 valve was approved in Europe in January 2014 for the treatment of high-risk and inoperable patients with severe aortic stenosis. It is not approved for the treatment of intermediate risk patients in Europe. The valve is an investigational device not yet available commercially in the United States.

Clinical Outcomes at 30 Days with the SAPIEN 3 Valve (As-Treated)

Source: Edwards Lifesciences Corporation