Healthcare Industry News:  Edwards Lifesciences 

Devices Interventional Cardiology

 News Release - March 17, 2009

Edwards Lifesciences Completes Enrollment in Non-Surgical Study Arm of U.S. Clinical Trial for Transcatheter Valve

IRVINE, CA--(Healthcare Sales & Marketing Network)--Mar 17, 2009 -- Edwards Lifesciences Corporation (NYSE:EW ), the world leader in the science of heart valves, today announced completion of enrollment in the 350-patient non-surgical study arm of its U.S. pivotal trial -- known as the PARTNER Trial -- for the Edwards SAPIEN transcatheter aortic heart valve.

"Reaching this milestone is a significant achievement for the subset of patients suffering from severe aortic stenosis who can't tolerate conventional aortic valve replacement. Without a transcatheter heart valve, they have no definitive treatment options for addressing their valve disease," said Craig Smith, M.D., interim surgeon-in-chief and chief of cardiothoracic surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center, the Calvin F. Barber Professor of Surgery at Columbia University College of Physicians and Surgeons, and co-principal investigator for the trial.

The PARTNER (Placement of AoRTic traNscathetER valves) Trial is a randomized, controlled, multi-center study that assigns patients into one of two arms: a "non-surgical" arm, in which the Edwards SAPIEN valve is compared to non-surgical treatments, and a "surgical" arm, in which the Edwards SAPIEN valve is compared to traditional surgical aortic valve replacement.

The company also announced it plans to provide continued access at PARTNER study sites to the Edwards SAPIEN valve for non-surgical patients meeting study criteria, pending FDA approval.

"The dedication of the PARTNER sites in screening and randomizing complex patients is an important achievement. The medical community anxiously awaits results from this landmark trial, which I believe will benchmark the performance of the Edwards SAPIEN valve versus medical management therapies in these high risk patients," said Martin B. Leon, M.D., associate director of the Cardiovascular Interventional Therapy (CIVT) Program at NewYork-Presbyterian Hospital and Columbia University Medical Center, professor of medicine at Columbia University College of Physicians and Surgeons, and co-principal investigator for the U.S. PARTNER Trial.

Edwards is the only company with a U.S. investigational device exemption (IDE) pivotal study underway for a transcatheter aortic valve replacement, and the only company to have both transfemoral and transapical transcatheter valve delivery systems commercially available in Europe.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company's global brands include Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at http://www.edwards.com.

Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, Magna, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office. PARTNER is a service mark of Edwards Lifesciences Corporation.


Source: Edwards Lifesciences

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