SOURCE: Edwards Lifesciences

Edwards Lifesciences

September 22, 2010 18:39 ET

The New England Journal of Medicine Publishes Transcatheter Heart Valve Trial Results

PARTNER Trial Successfully Meets Primary Endpoints

IRVINE, CA--(Marketwire - September 22, 2010) -  Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, reported that The New England Journal of Medicine today published results from Cohort B of The PARTNER Trial, which studied the Edwards SAPIEN transcatheter heart valve for the treatment of severe aortic stenosis. The results of the trial successfully met the primary endpoints of all-cause mortality and mortality plus repeat hospitalization. 

The study authors concluded, "in patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI [transcatheter aortic valve implantation], as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events." The article further states, "on the basis of a rate of death from any cause at one year that was 20 percentage points lower with TAVI than with standard therapy, balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery."

According to the study authors, "aortic stenosis is an insidious disease with a long latency period followed by rapid progression after the appearance of symptoms, resulting in a high rate of death" and concluded that "standard medical therapy... did not alter the natural history of severe aortic stenosis."

"The commitment and partnership demonstrated by the interventional cardiologists, surgeons and their heart teams during this very rigorous trial was inspiring as they diligently seek new treatment options for their patients," said Michael A. Mussallem, Edwards' chairman and CEO. 

This trial studied 358 patients with severe, symptomatic aortic stenosis deemed inoperable for traditional open-heart surgery. Patients were evenly randomized to receive either the Edwards SAPIEN valve or standard therapy. 

The Edwards SAPIEN transcatheter valve is an investigational device in the U.S. and not yet available commercially in this country. 

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 is a trademark 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.

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