FDA clears Sapien 3 for high-risk TAVR patients

The FDA approved the third-generation transcatheter aortic valve replacement (TAVR) device by Edwards Lifesciences, giving the company permission to market the Sapien 3 system as a treatment for high-risk patients with severe aortic stenosis.

This is the third device approved for Edwards Lifesciences, which became the first to market in the U.S. with approval of the first-generation balloon-expandable Sapien TAVR device for treating inoperable patients in 2011 and high-risk patients in 2012. In June of 2014, the FDA approved the Sapien XT for the same two patient populations. Medtronic is the only other company with an FDA-approved device, the self-expanding CoreValve.

The Sapien 3 has a smaller profile than the Sapien XT with an outer skirt that is designed to reduce paravalvular leak. The valve is available in 20mm, 23mm, 26mm and 29mm sizes. The FDA approval includes the Commander Delivery System, which is expected to facilitate accurate positioning of the valve.

In a presentation at the 2015 American College of Cardiology’s scientific sessions in San Diego, the Sapien 3 was shown to have a 30-day all-cause mortality rate of 2.2 percent in high-risk patients and 1.1 percent in intermediate-risk patients; all-stroke rates of 1.54 percent and 2.6 percent; disabling stroke rates of 0.86 percent and 1.02 percent; and significant paravalvular leak rates of 3 percent and 4.2 percent, respectively.

The results were based on single-arm, nonrandomized cohorts of patients in the U.S. who participated in the PARTNER II Trial. According to Edwards Lifesciences, the FDA reviewed data on the 583 high-risk patients at 29 U.S. sites to make its decision.

The company plans to have the Sapien 3 fully launched in the U.S. by the end of this year. The device received CE mark in Europe in early 2014.