Edwards Lifesciences Receives U.S. Approval For Landmark Transcatheter Heart Valve Pivotal Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 21 Mar 2007 - 0:00 PDT

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Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced today that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial of its Edwards SAPIEN transcatheter aortic heart valve technology. The PARTNER (Placement of AoRTic traNscathetER valves) trial will evaluate the SAPIEN valve in patients who are considered high risk for conventional open-heart valve surgery.

"This is a significant and exciting milestone for our transcatheter heart valve program and for Edwards Lifesciences," said Michael A. Mussallem, chairman and CEO. "We have worked closely with the FDA to design a trial that will compare the innovative SAPIEN heart valve with the current standards of care for high risk patients. We believe our revolutionary technology holds promise for the large number of high risk patients suffering from severe aortic stenosis."

Edwards' PARTNER trial is a prospective randomized clinical trial with two separate treatment arms. The surgical arm of the trial will focus on approximately 350 high risk patients who are candidates for conventional open-heart surgery. Those patients will be evenly randomized to receive either the Edwards SAPIEN transcatheter heart valve or surgical valve replacement. The clinical results of this arm will need to demonstrate that the SAPIEN valve is not statistically inferior to conventional surgery.

The medical management arm of the trial will focus on approximately 250 patients that are considered too high risk for conventional open-heart surgery. Those patients will be evenly randomized to receive either the Edwards SAPIEN transcatheter heart valve or appropriate medical therapy. The clinical results of this arm will need to demonstrate that the SAPIEN valve is statistically superior to medical management.

The primary endpoint in both arms of the trial is mortality at one year with secondary endpoints that focus on valve performance and quality-of-life indicators. Each arm of the trial contains a sufficient number of patients to support independent statistical analysis.

Initially, clinicians in the PARTNER trial will deliver the SAPIEN valve using Edwards' RetroFlex transfemoral delivery system. In the third quarter of this year, the company expects to add its Ascendra transapical delivery system to the trial. "We are pleased with our global transapical experience and look forward to making Ascendra available as soon as possible," said Mussallem.

Edwards will start enrolling at two initial study sites: New York-Presbyterian/Columbia University Medical Center, New York, and The Cleveland Clinic Foundation, Cleveland, Ohio. Both sites were part of the company's earlier transfemoral feasibility study. Before expanding to 15 U.S. study sites, Edwards needs to submit additional follow-up data from the original 55-patient feasibility study.

About Transcatheter Heart Valve Replacement

The Edwards SAPIEN transcatheter aortic heart valve integrates balloon-expandable stent technology with a replacement tissue heart valve. The SAPIEN valve is compressed onto the balloon to the approximate diameter of a pencil and threaded through the patient's circulatory system from the leg or inserted between the ribs and expanded directly over the aortic valve. The SAPIEN valve is a proprietary technology designed to treat patients with severe aortic heart valve stenosis (a narrowing of the valve that restricts blood flow) who are considered to be high risk for conventional open-heart valve replacement surgery. The therapy was originally developed in conjunction with Prof. Alain Cribier, M.D., chief of cardiology at the University Hospital in Rouen, France, who performed the first transcatheter valve replacement in April 2002.

About Edwards Lifesciences

Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular opportunities including heart valve disease, peripheral vascular disease and critical care technologies. The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, LifeStent, PERIMOUNT Magna, and Swan-Ganz. Additional company information can be found at http://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 include, but are not limited to, the company's ability to successfully complete the PARTNER clinical trial, timely regulatory approval of the Edwards SAPIEN transcatheter aortic heart valve and the market 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.

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, 2006.

Edwards, Edwards SAPIEN and FloTrac are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, Carpentier-Edwards, Cosgrove-Edwards, Fogarty, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office. LifeStent is a trademark of Edwards Lifesciences AG and is registered in the United States Patent and Trademark Office.

Edwards Lifesciences
http://www.edwards.com