FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs / Submissions and Approvals / Research and Development

Edwards’ Intuity Elite Valve System Gets CE Mark

April 7, 2014

European regulators have granted Edwards Lifesciences’ next-generation Intuity Elite valve system CE Mark approval, the Irvine, Calif., devicemaker said Friday.

The decision was based on a 100-patient randomized, controlled and multicenter clinical trial that compared minimally invasive Intuity aortic valve replacement with full sternotomy aortic valve replacement with a conventional bioprosthetic aortic valve.
Results showed Intuity significantly cut ischemic time compared with conventional approaches and improved blood flow and hemodynamics after three months.

Intuity draws on a balloon-expandable frame and the company’s Perimount platform. The flexible, lower-profile delivery system allows surgeons to make smaller incisions, reducing cross-clamp time and improving hemodynamics, the company says. The system’s three guiding sutures and expanded frame enable rapid delivery and consistent suture technique.

Edwards is currently making the system available to hospitals across Europe. Intuity is investigational in the U.S. The company hopes to make it available in 2016. — Lena Freund

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