FDAnews Device Daily Bulletin
Medical Devices / Research and Development / Commercial Operations

Edwards’ Intuity Valve Performs Well in Three-Year Follow-Up Study

May 1, 2014

Edwards Life Sciences’ Intuity valve platform demonstrated improved cardiac and valvular performance and patient functional status in a three-year interim analysis, the Irvine, Calif., devicemaker said Wednesday.

The Triton trial, which kicked off in 2011, evaluated 287 adult patients in Switzerland, Germany and Austria with aortic stenosis or stenosis-insufficiency of the aortic valve that required a planned replacement. Of these, 138 were given the next-generation Intuity Elite rapid-deployment valve.

At three-year follow-up, patients with Intuity had improved heart function, evidenced by a 16 percent reduction in left ventricular mass index. Intuity also was associated with a low aortic valve pressure gradient, indicating a statistically significant improvement in hemodynamic performance, Edwards said.

Intuity is comprised of a bovine pericardial heart valve and balloon-expandable frame that allow surgeons to perform valve replacements using a smaller incision and fewer sutures, the company said.

Intuity Elite was CE marked in Europe last month, but remains investigational in the U.S. The company hopes to complete a U.S. trial later this year and potentially launch the valve by 2016. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.