IRVINE, Calif., Jan. 29 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today announced that it has received conditional approval from the U.S. Food and Drug Administration (FDA) for a revised design to the U.S. pivotal clinical trial of the Edwards SAPIEN transcatheter aortic heart valve technology. The FDA approved the addition of the Ascendra transapical delivery system to the trial, and also granted permission to Edwards to increase its trial sample size from 600 patients to 1,040 patients.
The PARTNER (Placement of AoRTic traNscathetER valves) trial, initiated in the second quarter of 2007, is evaluating the Edwards SAPIEN valve in patients who are considered high risk or inoperable for conventional open-heart valve surgery.
"The addition of the Ascendra transapical delivery system to the PARTNER trial will enable Edwards to address a larger population of patients who may have few or no options for treatment of their heart valve disease," said Michael A. Mussallem, Edwards Lifesciences' chairman and CEO. "Incorporating Ascendra along with increasing the number of patients in the trial also will better ensure that the trial endpoints are successfully met."
With these trial revisions, patients with symptomatic, calcific aortic stenosis -- a narrowing of the aortic valve that reduces the outward flow of oxygenated blood -- will be evaluated for inclusion in one of two separate treatment arms, surgical or medical management. "The addition of the transapical approach to the PARTNER trial is an important milestone for cardiac surgeons and their patients. The transapical approach greatly expands the options for patients who need aortic valve replacement, but face excessive risk with alternative approaches," said Craig Smith, M.D., Chief of the Division of Cardiothoracic Surgery at New York-Presbyterian Hospital/Columbia University Medical Center and the co-principal investigator for the U.S. PARTNER trial.
The surgical arm of the trial evaluates the Edwards SAPIEN valve and the two transcatheter delivery systems -- Ascendra for transapical access, and RetroFlex for transfemoral access -- as compared to surgical, open-heart valve replacement. The medical management arm of the trial evaluates the Edwards SAPIEN valve with the RetroFlex transfemoral delivery system as compared to appropriate medical therapy.
Edwards has significant experience with transcatheter valve procedures based on more than 600 implants of the transcatheter heart valve through a series of extensive clinical trials and feasibility studies in Europe, the U.S. and Canada. The Edwards SAPIEN valve with the Ascendra transapical and RetroFlex transfemoral delivery systems is commercially available in Europe.
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 disease states including heart valve disease, 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, 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.
Ascendra, Edwards, Edwards SAPIEN and RetroFlex are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.
|SOURCE Edwards Lifesciences|
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