New Data on Edwards PERIMOUNT Valves Demonstrate Long-Term Durability in Patients Aged 60 and Younger
MARSEILLE, FRANCE -- (Marketwired) -- 06/17/13 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced unprecedented long-term durability results for bovine pericardial heart valves, based on a study of the Carpentier-Edwards PERIMOUNT aortic valve in a subset of patients aged 60 or younger at the time of operation. The study tracked patients over a nearly 25-year period, achieved follow-up of 3,299 valve years and determined that expected valve durability for this population was greater than 17 years. The data were presented Friday at the 66th Congress of the French Society for Thoracic and Cardiovascular Surgery by Thierry Bourguignon, M.D., from University Hospital of Tours, France.
Between July 1984 and Dec. 2008, 373 patients had aortic valve replacement with the PERIMOUNT valve. The valve, which was introduced into clinical use in 1981, is bio-engineered with precisely-matched leaflets made from bovine pericardial tissue that are hand-sewn onto a stainless steel frame. The design of the valve, including its frame and leaflets, serves as the model upon which Edwards' leading surgical products, Magna Ease and Magna Mitral Ease, are based.
"Pericardial valve use has increased over time. These long-term data on the PERIMOUNT valve strengthen the evidence for surgeons to utilize Edwards' pericardial tissue valves, including in selected patients of age 60 and under," said Prof. Michel Aupart, M.D., head of the Department of Cardiovascular and Thoracic Surgery, University Hospital of Tours, France, and a paid consultant to Edwards.
At the American Association for Thoracic Surgery (AATS) Mitral Conclave in May, Dr. Bourguignon also presented 25-year data on patients receiving mitral valve replacement with the Carpentier-Edwards PERIMOUNT valve, with follow-up of 3,258 valve years. The data similarly showed that the PERIMOUNT valve had an expected durability of more than 16 years in the mitral position, for the entire cohort and dependent on the patient's age. The study followed 404 consecutive patients with a mean age of 68 at the time of their mitral valve surgery, which took place between August 1984 and March 2011. Edwards has the only tissue valve specifically designed for the mitral position.
"More than 500,000 patients around the world have benefitted from valve replacement with Edwards' PERIMOUNT platform, and thousands more each year receive treatment with our market-leading surgical and transcatheter valves," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy. "These data offer yet another compelling, real-world experience to validate the excellent performance of the PERIMOUNT valve design for patients."
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring, enabling them to save and enhance lives. Additional company information can be found at www.edwards.com.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, Mr. Bobo's statements. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unexpected outcomes in clinical experience or unanticipated manufacturing or quality issues. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2012.
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Magna Ease, Magna Mitral Ease and PERIMOUNT are trademarks of Edwards Lifesciences Corporation.