News Details

The U.S. Food and Drug Administration has approved the Carpentier-Edwards mitral PERIMOUNT Pericardial Bioprosthesis, the country's only bovine pericardial tissue heart valve designed specifically for the mitral position, Edwards Lifesciences Corporation announced today. Edwards, the worldwide leader in tissue replacement heart valves and heart valve repair products, introduced the Carpentier-Edwards PERIMOUNT valve for U.S. aortic patients in 1991, and now adds the mitral counterpart, providing a next-generation treatment option for thousands of patients who suffer from advanced mitral heart valve disease. Surgical implants of the new mitral PERIMOUNT valve are expected to begin immediately.

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"Edwards' PERIMOUNT pericardial valve is the most widely implanted tissue valve in the world. Now this important pericardial therapy is available to U.S. mitral valve patients for the first time," said Michael A. Mussallem, Edwards' chairman and CEO. Mussallem noted that although this therapy is new to U.S. patients, the Carpentier-Edwards mitral PERIMOUNT valve has been implanted in thousands of patients outside of the United States, gaining more than a decade of proven clinical results. "In published clinical studies, the PERIMOUNT valves in both the aortic and mitral positions have shown outstanding durability and performance," he said.

"Edwards' new PERIMOUNT pericardial valve is also the first biomechanically engineered valve developed specifically for replacement of the human mitral valve," Mussallem added, noting that all porcine tissue valves are made from pigs' native aortic valves, whether they are intended to replace a patient's aortic or mitral valve. Porcine valves are not designed for the higher physiological pressures experienced in the human mitral valve, and long-term durability under these higher pressures has been a critical issue limiting the use of tissue valves in mitral valve replacement.

Tissue Valves Offer Quality-of-Life Benefits for Patients

Cardiovascular disease is the No. 1 cause of death in the world and among the top three diseases in terms of healthcare spending in nearly every country in the world. Each year, an estimated 300,000 people worldwide undergo open-heart surgery to treat their malfunctioning or diseased heart valves. Of these surgeries, more than one-third are mitral valve procedures. In many cases, surgeons choose to replace an affected valve with either a "bioprosthetic" valve, generally made of animal tissue, or a "prosthetic" mechanical valve made of metal and carbon. Due to their quality-of-life benefits and improvements over previously available bioprosthetic valves, tissue valves are increasingly chosen by clinicians and their patients over mechanical valves, and are the fastest-growing area of heart valve therapy products in the United States.

"One of the advantages of tissue valves is that patients do not have to take blood thinning agents on a long-term basis, as they do with mechanical valves," said Dr. Lawrence H. Cohn, professor of surgery at Harvard Medical School and chief of the Division of Cardiac Surgery at Brigham and Women's Hospital in Boston. "That's a tremendous advantage for a patient's quality of life."

Recent guidelines published by the American College of Cardiology and the American Heart Association (AHA) recommend the use of tissue valves in patients as young as 65 years of age. The AHA also recognizes that "pericardial bioprostheses may have a lower rate of structural valve deterioration than porcine bioprostheses."

Edwards' PERIMOUNT valve was developed by Dr. Alain Carpentier, chairman of the Department of Cardiovascular Surgery at the Hopital Europeen Georges Pompidou in Paris, working with bioengineers at Edwards Lifesciences. The development involved Edwards' proprietary tissue preservation process, a resilient wireframe stent optimally designed using computer-aided 3-D modeling techniques, patented technology for tissue selection, and integrated manufacturing processes that make the valve robust and able to withstand the increased pressures of the mitral position. The PERIMOUNT valve's clinical success is the precisely engineered result of material, design and process -- all optimized for the requirements of the mitral position.

"The reported experience with mitral PERIMOUNT suggests that we now have a tissue valve for the mitral position that has excellent durability, similar to that of the pericardial valve in the aortic position. We've been looking forward to having this valve in our repertoire for a number of years, and it is finally here," said Dr. Delos M. Cosgrove, chairman of the Department of Thoracic and Cardiovascular Surgery at The Cleveland Clinic Foundation.

Edwards is hosting the first-ever Web broadcast of an implantation of its PERIMOUNT pericardial valve in the mitral position at http://www.perimount.com/. The site provides details about the product and webcast, which also will feature commentary from renowned surgeons regarding the impact of this new option on valve selection, a review of long-term clinical data and a patient's perspective on his PERIMOUNT heart valve.

"The Carpentier-Edwards PERIMOUNT is a next-generation technology, offering surgeons, cardiologists and their patients greater options than just porcine or mechanical valves," said Edwards' CEO Mussallem. "The mitral PERIMOUNT valve is the latest in a long history of 'firsts' for Edwards and is the only mitral pericardial valve commercially available in the U.S., illustrating our continuing efforts to help patients around the world fight late-stage cardiovascular disease."

Edwards Lifesciences designs, develops and markets a comprehensive line of products and services to treat late-stage cardiovascular disease. Headquartered in Irvine, Calif., Edwards focuses on cardiac surgery, critical care, vascular systems and perfusion products and services, and is a worldwide leader in tissue replacement heart valves and heart valve repair products. With pro forma sales of more than $800 million in 1999, the company has a strong international presence in over 80 countries and generates more than 35 percent of its sales outside of the United States. Edwards' extensive manufacturing operations are located in North America, Europe, Japan (through a contractual joint venture with Baxter International) and Latin America. Additional information about Edwards Lifesciences can be found at http://www.edwards.com/.

This news release includes forward-looking statements that involve risks and uncertainties, including those related to the successful U.S. launch and sales of the Carpentier-Edwards mitral PERIMOUNT Pericardial Bioprosthesis, targeted financial and operating objectives, timing or results of pending or future clinical trials, actions by the U.S. Food and Drug Administration and European Union, technological advances in the medical field, product demand and market acceptance, and other risks detailed in the company's filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.

Edwards Lifesciences and Edwards are trademarks of Edwards Lifesciences Corporation. Carpentier-Edwards and PERIMOUNT are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark Office.

SOURCE: Edwards Lifesciences Corporation