Unprecedented Long-Term Durability From New Data On Edwards PERIMOUNT Valves

Heart valve company Edwards Lifesciences Corporation, has announced what it is calling unprecedented long-term durability results for bovine pericardial heart valves. A study of the Carpentier-Edwards PERIMOUNT aortic valve in a subset of patients aged 60 or younger at the time of operation 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.

Background

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.

The data were presented at the 66th Congress of the French Society for Thoracic and Cardiovascular Surgery by Thierry Bourguignon, M.D., from University Hospital of Tours, France.

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.

Physician comments

“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.

Company comments

“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.”

Source: Edwards Lifesciences Corporation