SOURCE: Edwards Lifesciences - Global Communications

Edwards Lifesciences - Global Communications

May 25, 2010 09:37 ET

Edwards SAPIEN Transcatheter Heart Valve Shows Positive One-Year Outcomes in Rigorous Post-Market Study

PARIS--(Marketwire - May 25, 2010) -  Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that Martyn Thomas, M.D., reported that the Edwards SAPIEN transcatheter heart valve demonstrated promising one-year mortality rates for high-risk patients, many of whom were too sick to undergo traditional open-heart surgery. The 1,038-patient SOURCE Registry is the largest reported experience in the world with one-year adjudicated data on consecutive patients treated with transcatheter heart valves with either a transfemoral or transapical approach. 

The data presented today at EuroPCR, the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), showed a one-year survival rate of 81.1 percent in transfemoral procedures (valve delivered via the femoral artery) and 72.1 percent in transapical procedures (valve delivered via a small incision through the ribs).  

"The encouraging outcomes add to the evolving body of clinical evidence that demonstrates transcatheter aortic valve implantation is a viable option for this high-risk patient population. The data provide valuable, real world insights that enable the continued advancement of this important treatment for patients in need of alternative therapies to traditional open-heart surgery," said Dr. Thomas, director of cardiothoracic services, Guys and St. Thomas' NHS Foundation Trust in London.

The SOURCE Registry includes outcomes data from 100 percent of patients treated with the Edwards SAPIEN transcatheter heart valve at 32 European centers from November 2007 to January 2009 in its initial Cohort I. One year follow-up data was obtained on 98 percent of studied patients. Dr. Thomas also announced that 30-day results on an additional cohort of 1,301 patients (Cohort 2) enrolled in 2009 will be reported in the fall.

"The SOURCE Registry is unprecedented in its rigor as a commercial registry, which is critical for our understanding of the developing therapy of transcatheter aortic valve implantation. The one-year outcomes continue to demonstrate that European clinical teams are translating early clinical learnings into successful therapy in an appropriate patient population," said Olaf Wendler, M.D., Ph.D., Clinical Director for Cardiology and Cardiothoracic Surgery, King's College Hospital in London.

Drs. Thomas and Wendler provide paid consulting services to Edwards for education, and research and development of transcatheter valve technologies.

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

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 can sometimes be identified by the use of words such as "may," "will," "should," "anticipate," "believe," "plan," "project," "estimate," "expect," "intend," or other similar expressions and include, but are not limited to, the timing and progress of clinical studies relating to the company's transcatheter valve technologies and the market opportunity for transcatheter technologies. 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 actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements 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, 2009.

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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