Edwards Reports First Data for Sapien 3 Transcatheter Valve

May 20, 2014—Edwards Lifesciences announced that the first data on the Edwards Sapien 3 transcatheter aortic heart valve were presented in a late-breaking clinical trial session at EuroPCR 2014 by John Webb, MD, a principal investigator of the SAPIEN3 trial. The EuroPCR 2014 congress is being held May 20–23 in Paris, France. Dr. Webb is Director of Interventional Cardiology and Cardiac Catheterization Laboratories at St. Paul’s Hospital and Professor of Cardiology at the University of British Columbia in Vancouver, British Columbia, Canada.

According to the company, the presentation concluded that outcomes at 30 days were excellent. Transfemoral Sapien 3 implantation was associated with a very low mortality of 2.1%, a stroke rate of 1%, and very few access site complications. In addition, 96.6% of patients had ≤ mild paravalvular leak. There was no severe paravalvular leak. The percent figures are Kaplan-Meier estimates.

In Edwards’ press release, Dr. Webb commented, “These data demonstrated that the improved valve and delivery system design allowed precise positioning of the Sapien 3 valve, and early outcomes from the trial clearly demonstrated outstanding safety. The results of this study indicate the Sapien 3 valve may enable treatment of intermediate-risk patients with aortic stenosis.”

According to Edwards Lifesciences, the SAPIEN3 trial is a prospective, multicenter, nonrandomized study. This analysis documented early outcomes of the first 150 high- and intermediate-risk patients enrolled between January 2013 and November 2013, and treated with the Sapien 3 valve at 16 centers in Europe and Canada. Access approaches included transfemoral (n = 96) and transapical/transaortic (n = 54), as determined by the heart team. All-cause mortality in all access approaches was reported as 5.3% in the as-treated population. The company intends for patients to be followed annually out to 5 years.

The Sapien 3 valve can be delivered through a low-profile, 14-F expandable sheath (the company’s eSheath). It also has an outer skirt, which is a cuff of fabric that provides a seal at the bottom of the frame to reduce paravalvular aortic regurgitation.

The Sapien 3 valve was approved in Europe in January 2014 for the treatment of high-risk and nonoperable 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, where it is being evaluated in the PARTNER II trial, stated Edwards Lifesciences.