Preliminary Data on Odyssey Aortic Valve Platform Show Intraoperative Benefits With Rapid Deployment Valve

Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, announced the U.S. and European launches of its Carpentier-Edwards PERIMOUNT Magna Mitral Ease valve, designed to enhance implantation in the challenging mitral position. The launch is taking place at the 24th Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS).

The Magna Mitral Ease valve incorporates new features to facilitate access, placement and suturing during both conventional and minimally invasive heart valve surgeries, especially those using a thoracotomy. Its product enhancements, such as the tri-colored holder, unique suture guide line, wide saddle-shaped cuff and new accessories are all designed for easier implantation. Magna Mitral Ease is based on the clinically proven and durable Edwards PERIMOUNT mitral valve design, which has more than 250,000 patient years of experience worldwide. Patients with tissue valves such as Magna Mitral Ease minimize the need for the lifelong prescription of blood thinners and its associated risks.

"Magna Mitral Ease can help us to achieve continuous improvements in the treatment of patients by maintaining the excellent hemodynamics of its predecessor, while improving and simplifying mitral valve implantation," said Prof. Jan Gummert, University Hospital of the Ruhr-University of Bochum, Germany. The clinic at the Ruhr-University was the first worldwide to implant the Magna Mitral Ease valve using a minimally invasive thoracotomy procedure.

At Saturday's EACTS TechnoCollege, Dr. Malakh Shrestha, Hannover Medical School, Hannover, Germany, provided a preliminary, single-center case presentation on Edwards' investigational, minimally invasive, rapid deployment Odyssey aortic valve platform. This initial series of aortic valve replacement (AVR) procedures at Hannover using the Odyssey platform demonstrated an approximately 50 percent reduction in bypass and cross-clamp times when compared to conventional, isolated aortic valve surgery. The Odyssey platform is currently being studied in Europe as part of the TRITON trial, and additional data are expected to be announced after enrollment and patient follow-up is complete.

"The Odyssey platform is designed to simplify and facilitate minimally invasive aortic valve surgery, thereby enabling shorter cardiopulmonary bypass times due to its unique implantation method. We believe these procedural enhancements may also improve patient outcomes," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy.

Prof. Gummert and Dr. Shrestha provide paid consulting services to Edwards Lifesciences for educational programs.

About the Carpentier-Edwards PERIMOUNT Magna Mitral Ease
The Carpentier-Edwards PERIMOUNT Magna Mitral Ease heart valve is a pericardial tissue-based bioprosthetic device for patients requiring replacement of diseased mitral heart valves. It is based on the Edwards PERIMOUNT mitral valve design. Multiple studies have demonstrated the PERIMOUNT Magna Mitral valve's long-term endurance.