Edwards Lifesciences Receives CE Mark For New Transfemoral Transcatheter Valve Delivery System

Main Category: Medical Devices / Diagnostics
Also Included In: Heart Disease;  Cardiovascular / Cardiology;  Regulatory Affairs / Drug Approvals
Article Date: 15 Feb 2009 - 2:00 PDT

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Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced today that it received CE Mark approval for European commercial sales of the new RetroFlex 3 transfemoral delivery system for the Edwards SAPIEN transcatheter heart valve.

The RetroFlex 3 delivery system is designed to optimize the physician's ability to control the navigation of the valve, through the incorporation of the valve expansion balloon directly into the delivery system's flexible tip. The new design also facilitates the crossing of the patient's native aortic valve, which in this population is calcified as a result of severe aortic stenosis.

"The delivery system for the Edwards SAPIEN transcatheter valve is a critical component in facilitating the delivery and implantation of the valve," said Patrick Verguet, Edwards' corporate vice president, Europe. "Our continued focus on developing new delivery systems enables us to respond to the needs of physicians utilizing the transcatheter valve in high-risk European patients. We are actively seeking opportunities to incorporate features that address the patient's anatomy, disease state and desire for a simpler procedure."

Edwards is the only company to provide both transfemoral and transapical delivery systems for transcatheter aortic valve replacement. With both approaches, the Edwards SAPIEN valve delivery is performed while the heart continues to beat and without open-heart surgery or cardiopulmonary bypass.

The Edwards SAPIEN transcatheter heart valve with the RetroFlex 3 transfemoral and Ascendra transapical delivery systems is approved for commercial sale in Europe. In the United States, the Edwards SAPIEN valve is an investigational device that is being studied in the PARTNER randomized clinical trial, and is not available for sale.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company's global brands include Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at http://www.edwards.com.

Edwards, RetroFlex and RetroFlex 3 are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Ascendra, Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna, and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.

Edwards Lifesciences

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