IRVINE, Calif., Oct. 16 -- Edwards Lifesciences Corporation (NYSE: EW), the world's leader in heart valve replacement and repair products, announced today that it has completed a 16-year follow-up of the effectiveness and durability of its Carpentier-Edwards PERIMOUNT mitral pericardial heart valve. The data provide clinicians with further evidence of the long-term durability of Edwards' patented PERIMOUNT technology, which incorporates biomechanically engineered bovine pericardial tissue.
The data, compiled at seven centers in Europe and Canada, followed more than 430 patients. The report concluded that patients 60 years and older who received the valve had a nearly 90 percent chance of not needing a new valve, due to structural valve deterioration, for 16 years. The study also confirms the valve's safety through a low incidence of complications, such as bleeding and thromboembolism.
""These positive clinical data demonstrate, for the first time, the ability of biomechanically engineered pericardial tissue to endure the higher stresses that are unique to the mitral valve position,"" said Professor Alain Carpentier, chairman of the Department of Cardiovascular Surgery at the Hopital Europeen Georges Pompidou in Paris. ""This study is an important development for patients, as surgeons are more likely to recommend valves based upon strong, long-term clinical evidence.""
Edwards also recently introduced in the U.S. its new, ultra-low profile Tricentrix holder, which is designed to offer better visualization and operating space for surgeons implanting the PERIMOUNT mitral valve by allowing the valve to quickly and easily ""parachute"" into the precise opening of the patient's native valve.
""These excellent data, combined with recent 20-year durability data on our PERIMOUNT aortic valve and the launch of our Tricentrix holder system, reinforce Edwards' leadership position in the heart valve market,"" said Anita B. Bessler, Edwards' corporate vice president of Global Franchise Management. ""Edwards' PERIMOUNT mitral valve provides patients with the benefits of long- term durability combined with significant quality-of-life advantages."" The global heart valve market currently represents approximately $900 million in annual revenues.
Tissue Valves Offer Quality-of-Life Benefits for Patients
Each year, more than 300,000 people worldwide undergo open-heart surgery to treat their malfunctioning or diseased heart valves. Patients with mitral valve problems often suffer from degenerative heart valve disease, which in many cases leaves a patient's native valve too damaged to permit repair and makes replacement surgery the only option. Edwards' PERIMOUNT mitral pericardial heart valve provides patients with the most durable tissue alternative, as well as enhanced quality of life without the clicking noises or requirements for anticoagulation medication and dietary restrictions commonly associated with mechanical valves.
Due to their quality-of-life benefits, 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.
About Edwards Lifesciences
Edwards Lifesciences is a leader in advanced cardiovascular disease treatments and the number-one heart valve company in the world. Headquartered in Irvine, Calif., Edwards focuses on four main cardiovascular disease states: heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure. The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, Swan-Ganz and Fogarty. Additional company information can be found at www.edwards.com .
Edwards Lifesciences, Edwards, and Tricentrix are trademarks of Edwards Lifesciences Corporation. Carpentier-Edwards, PERIMOUNT, Cosgrove-Edwards, Swan-Ganz and Fogarty are trademarks of Edwards Lifesciences Corporation, registered in the U.S. Patent and Trademark Office.
This news release includes forward-looking statements that involve risks and uncertainties, including those related to 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, the effect of changing economic conditions, the impact of foreign exchange, 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.
Contact Information :
Media, Barry R. Liden, +1-949-250-5070
, or Investors, David K. Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation