IRVINE, Calif., Jan. 29 Edwards LifesciencesCorporation (NYSE: EW), the world leader in the science of heart valves, todayannounced that it has received conditional approval from the U.S. Food andDrug Administration (FDA) for a revised design to the U.S. pivotal clinicaltrial of the Edwards SAPIEN transcatheter aortic heart valve technology. TheFDA approved the addition of the Ascendra transapical delivery system to thetrial, and also granted permission to Edwards to increase its trial samplesize from 600 patients to 1,040 patients.
The PARTNER (Placement of AoRTic traNscathetER valves) trial, initiated inthe second quarter of 2007, is evaluating the Edwards SAPIEN valve in patientswho are considered high risk or inoperable for conventional open-heart valvesurgery.
"The addition of the Ascendra transapical delivery system to the PARTNERtrial will enable Edwards to address a larger population of patients who mayhave few or no options for treatment of their heart valve disease," saidMichael A. Mussallem, Edwards Lifesciences' chairman and CEO. "IncorporatingAscendra along with increasing the number of patients in the trial also willbetter ensure that the trial endpoints are successfully met."
With these trial revisions, patients with symptomatic, calcific aorticstenosis -- a narrowing of the aortic valve that reduces the outward flow ofoxygenated blood -- will be evaluated for inclusion in one of two separatetreatment arms, surgical or medical management. "The addition of thetransapical approach to the PARTNER trial is an important milestone forcardiac surgeons and their patients. The transapical approach greatly expandsthe options for patients who need aortic valve replacement, but face excessiverisk with alternative approaches," said Craig Smith, M.D., Chief of theDivision of Cardiothoracic Surgery at New York-Presbyterian Hospital/ColumbiaUniversity 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 thetwo transcatheter delivery systems -- Ascendra for transapical access, andRetroFlex for transfemoral access -- as compared to surgical, open-heart valvereplacement. The medical management arm of the trial evaluates the EdwardsSAPIEN valve with the RetroFlex transfemoral delivery system as compared toappropriate medical therapy.
Edwards has significant experience with transcatheter valve proceduresbased on more than 600 implants of the transcatheter heart valve through aseries of extensive clinical trials and feasibility studies in Europe, theU.S. and Canada. The Edwards SAPIEN valve with the Ascendra transapical andRetroFlex transfemoral delivery systems is commercially available in Europe.
About Edwards Lifesciences
Edwards Lifesciences, a leader in advanced cardiovascular diseasetreatments, is the number-one heart valve company in the world and the globalleader in acute hemodynamic monitoring. Headquartered in Irvine, Calif.,Edwards focuses on specific cardiovascular disease states including heartvalve disease, vascular disease and critical care technologies. The company'sglobal brands, which are sold in approximately 100 countries, includeCarpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna andSwan-Ganz. Additional company information can be found athttp://www.edwards.com.
This news release includes forward-looking statements within the meaningof Section 27A of the Securities Act of 1933 and Section 21E of the SecuritiesExchange Act of 1934. These forward-looking statements include, but are notlimited to the company's ability to successfully complete the PARTNER clinicaltrial, timely regulatory approval of the Edwards SAPIEN transcatheter aorticheart valve and the market for transcatheter technologies. Forward-lookingstatements are based on estimates and assumptions made by ma