Study Initiated for Minimally Invasive Aortic Valve Surgery System
January 25, 2010 – First-in-man procedures and a feasibility study in Europe were recently initiated for a new minimally invasive aortic valve surgery system.
The study, TRITON, will test the Odyssey aortic valve replacement system. It is part of Edwards Lifesciences’ strategy to marry its expertise in heart valves with innovations in delivery to improve the valve surgery experience for both surgeons and their patients.
"The investigational Odyssey aortic valve replacement system is designed to enable surgeons to rapidly deploy a heart valve that offers excellent hemodynamics and proven durability, without requiring a traditional sutured approach. This is a great step forward for patients who are not high risk enough to qualify for transapical valve replacement, yet are seeking a less-invasive option," said Axel Haverich, M.D., whose team performed the first successful implants of the new system. Dr. Haverich is head of the department of cardiothoracic transplantation and vascular surgery at Hannover Medical School in Germany and provides paid consulting services to Edwards Lifesciences for research and development of products and services for heart valve replacement.
The Project Odyssey system leverages the design of the Carpentier-Edwards PERIMOUNT Magna Ease tissue heart valve to create a new valve platform with an innovative delivery and attachment system. It is designed to enable a faster procedure, shorter patient time on cardiopulmonary bypass and a smaller incision. The feasibility study for Project Odyssey, TRITON, is now is actively enrolling at several European sites.
For more information: www.edwards.com