Healthcare Industry News:  Edwards Lifesciences 

Devices Interventional Cardiology Regulatory

 News Release - May 26, 2010

Edwards Lifesciences Announces Receipt of CE Mark for Pulmonic Transcatheter Valve

IRVINE, CA, May 26--(HSMN NewsFeed) - Edwards Lifesciences Corporation (NYSE:EW ), the global leader in the science of heart valves and hemodynamic monitoring, today announced the receipt of CE Mark for the Edwards SAPIEN pulmonic transcatheter heart valve. The valve is designed to be an alternative to surgical valve replacement for patients suffering from congenital heart disease of the pulmonic valve and leverages the company's transcatheter valve technology, which has been used in more than 5,000 cases around the world.

"The Edwards SAPIEN pulmonic transcatheter heart valve gives clinicians the potential to eliminate one of the multitude of open-chest procedures that their young congenital heart patients will face in their lifetimes," said Ziyad M. Hijazi, M.D., M.P.H., director of the Rush Center for Congenital and Structural Heart Disease, chief of pediatric cardiology and professor in the departments of pediatrics and internal medicine at Rush University, Chicago. "As every re-operation increases a patient's risk of infection, illness and death, it is a gift to have a minimally invasive way to treat these fragile patients."

"We are proud to apply our extensive experience in heart valve innovation and leadership in transcatheter technology to provide a high-quality solution for patients with so many unmet needs," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement.

The Edwards SAPIEN pulmonic transcatheter valve's leaflet design is modeled after Edwards' clinically proven aortic tissue valves and its stainless steel frame provides high radial strength. Prior to delivery, the bovine pericardial tissue valve is compressed onto a balloon to the approximate diameter of a pencil. It is then threaded through the patient's circulatory system using the RetroFlex 3 transfemoral delivery system, which enables accurate deployment of the valve across the patient's pulmonary valve.

In the U.S., this valve is an investigational device currently being studied in the COMPASSION (COngenital Multicenter trial of Pulmonic vAlve regurgitation Studying the SAPIEN InterventIONal THV) clinical trial, which will assess the safety of the valve. The company completed its feasibility study of the valve and is progressing into the pivotal portion of the clinical trial with the goal of receiving a Humanitarian Device Exemption from the U.S. Food and Drug Administration.

Dr. Hijazi is the principal investigator of the COMPASSION clinical trial and a consultant to Edwards for education and research.

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 that enable them to save and enhance lives. Additional company information can be found at www.edwards.com.

Edwards and RetroFlex 3 are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo and Edwards SAPIEN are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.


Source: Edwards Lifesciences

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