Healthcare Industry News:  Edwards Lifesciences 

Devices Cardiology Surgery

 News Release - January 26, 2010

Edwards Lifesciences Initiates Clinical Study of Minimally Invasive Aortic Valve Surgery System

IRVINE, CA - (HSMN NewsFeed) - Edwards Lifesciences Corporation (NYSE:EW ), the world leader in the science of heart valves and hemodynamic monitoring, has completed first in man procedures and initiated a feasibility study in Europe for a novel minimally invasive aortic valve surgery system, known as Project Odyssey. The system is part of Edwards' 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 company will feature its full line of valve replacement and repair products at the 46th annual meeting of the Society of Thoracic Surgeons (STS) in Fort Lauderdale this week.

"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 Prof. Axel Haverich, M.D., whose team performed the first successful implants of the new system. 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.

"Project Odyssey is an exciting development that enables Edwards to take a substantial leap forward in extending minimally invasive options to patients with aortic valve disease," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy. "By combining important features of our market-leading pericardial tissue valves and learnings from our transcatheter valve program, we are creating products designed to offer a better experience for valve patients and their surgeons."

At STS, Edwards is introducing new minimally invasive accessories for use with its Carpentier-Edwards Physio II ring for mitral valve repair, in addition to providing education about aortic procedural techniques at an evening symposium, "Managing the Complexity of Aortic Valve Disease: Leading Approaches and Perspectives," on Jan. 25. William Ryan, M.D., of the Heart Hospital Baylor Plano in Plano, Texas, will lecture on minimally invasive approaches for aortic valve replacement, while Daniel Doyle, M.D., of the Quebec Heart & Lung Institute in Quebec City, Quebec, will discuss the latest outcomes in transcatheter aortic valve implantation using the Edwards SAPIEN valve with the Ascendra transapical delivery system.

The Edwards Lifesciences booth #908 at STS includes interactive stations for tissue heart valves and repair products, cardiac surgery systems demonstrations and simulators featuring its Edwards SAPIEN transcatheter aortic heart valve. The Edwards SAPIEN valve is approved for commercial sale in Europe. In the United States, it is an investigational device being studied as part of the PARTNER Trial.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company's global brands include Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at

Edwards, Carpentier-Edwards, Magna Ease and Physio II are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Ascendra, Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.

Source: Edwards Lifesciences

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