Edwards Lifesciences Announces First Live Implant of New BioPhysio Heart Valve

Edwards Lifesciences Corporation (NYSE: EW), the world's leader in heart valve technologies, announced today that the company has initiated the pivotal clinical trial of its next generation Carpentier-Edwards BioPhysio aortic valve, the only replacement heart valve designed to mimic the physiologic motion of a natural heart valve.

The world's first live implant of this new technology was simulcast in a presentation to attendees of the European Association of Cardio-thoracic Surgery (EACTS) Techno-College on September 11, 2004 . The surgery was performed at the Leipzig Heart Center in Leipzig , Germany by Prof. Alain Carpentier, Chairman of the Department of Cardiovascular Surgery at the Hopital Europeen Georges Pompidou in Paris, and Prof. Friedrich W. Mohr, Director of the Department of Cardiac Surgery at the Leipzig Heart Center .

The BioPhysio valve is a technology developed by Edwards Lifesciences based on biological research conducted by biochemist Sophie Carpentier, Ph.D. and her husband Prof. Carpentier. The valve is designed to combine the hemodynamic performance of a native valve with the ease of implant of a traditional stented valve. The BioPhysio valve's pericardial tissue leaflets are mounted on a flexible nitinol support structure and treated with Edwards' patented ThermaFix tissue process to maximize durability and ease of implantation. The unique scalloped sewing ring of the BioPhysio valve also allows it to be implanted above the orifice of the aortic valve; such "supra-annular" positioning has been shown to help maximize patient blood flow.

"The intraoperative echocardiogram performed during this first live case indicated excellent hemodynamic performance, similar to parameters that would be expected in a healthy natural valve," said Prof. Mohr.

"We expect that this new valve's unique design features, combined with the decades of durability demonstrated in Carpentier-Edwards PERIMOUNT tissue heart valves, should be a great benefit to patients who require aortic heart valve replacement," said Prof. Carpentier. "The BioPhysio valve's unique features are likely to make it a valuable therapeutic option for a young and active patient population, whose lifestyles require a high-performance valve that does not require anti-coagulant medication."

"The BioPhysio valve is the first stented valve that expands and contracts with each heart beat, which is designed to perform like a natural heart valve, but retain the ease of implantation characteristics of a stented valve," said Stuart L. Foster, Edwards' corporate vice president, Technology & Discovery. "Edwards is proud to partner again with one of the world's leading clinicians in the development of the next generation of surgical heart valves."

The BioPhysio clinical trial is a large, multicenter study that will take place in Europe , Canada and the United States . The enrollment period is , expected to last approximately 18 months, followed by an additional 12 to 18 months of post-procedural clinical monitoring and follow-up. Edwards expects the BioPhysio valve to be commercially available as early as 2008 in Europe and Canada , and later in the United States .

About Edwards Lifesciences

Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine , Calif. , Edwards focuses on specific cardiovascular opportunities including heart valve disease, peripheral vascular disease and critical care technologies.

The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, Fogarty, LifeStent, PERIMOUNT and Swan-Ganz. Additional company information can be found at http://www.Edwards.com.