IRVINE, Calif., May 8 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation , the world leader in the science of heart valves, announced that the company will celebrate a number of cardiac surgery milestones and product debuts at the 88th annual meeting of the American Association for Thoracic Surgery (AATS), May 10-14 in San Diego.
Among the milestones marked by Edwards -- which this year celebrates its 50th anniversary of partnering with clinicians to develop life-saving innovations -- are:
-- The treatment of more than 1 million patients worldwide with Edwards' heart valve repair and replacement technologies. -- The implantation of the Edwards SAPIEN transcatheter aortic heart valve in more than 1,000 patients worldwide through a series of extensive clinical trials and feasibility studies in Europe, the U.S. and Canada, as well as commercial sales in Europe. -- The start of patient enrollment for transcatheter aortic valve replacement procedures with the Ascendra transapical delivery system at participating sites in Edwards' U.S. pivotal trial of the Edwards SAPIEN valve. Edwards has conditional approval from the U.S. Food and Drug Administration to perform procedures with both the Ascendra transapical delivery system and the RetroFlex transfemoral delivery system at the PARTNER trial sites. -- Regulatory and reimbursement approval received this week from the Japanese Ministry of Health for the Carpentier-Edwards PERIMOUNT Magna pericardial aortic heart valve. As the first and only device of its kind, this valve combines more than 20 years of clinical experience and innovation with the most advanced tissue engineering technologies. The PERIMOUNT Magna valve is the best selling tissue valve in the world. New Products Edwards is also introducing and unveiling several new products at AATS: -- Edwards is offering new arterial and venous cannulae, which are the flexible tubes used to establish cardiopulmonary bypass in cardiac surgery. The new cannulae are designed to reduce trauma, increase efficiency and provide a variety of cannulation site options that address today's more challenging surgical approach. Among these are the FemTrak femoral venous cannula and the OptiSite arterial cannula, which both have proprietary ultra-thin wall technology to help optimize blood flow while a patient is on a heart-lung machine. -- The next-generation of the Carpentier-Edwards Physio annuloplasty ring will be unveiled. This product addresses the degenerative segment of mitral valve repair -- the largest segment within the repair market -- and features a ring design that better conforms to the patient's natural anatomy. The original Carpentier-Edwards Physio ring is the number-one global repair product and was launched in 1994.
"This year Edwards celebrates 50 years of working closely with the surgical community on the development of our pioneering heart valve repair and replacement products and cardiac surgery tools. We look forward to extending this partnership with surgeons as our industry continues to evolve," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy. "We will continue this valuable collaboration with surgeons to help shape the emerging minimally-invasive surgery practice and develop transformational therapies for patients. The new Edwards products featured at AATS will also support this goal."
Representatives from Edwards will be in the exhibition area at booth #1001. The booth features information on the new products and simulators for hands-on experience in transcatheter and minimally-invasive surgery techniques.
Clinical Presentations
Among the clinical presentations featuring data about Edwards' devices are:
Sunday, May 11 -- Session V, Percutaneous Aortic Valve Replacement: Update on Percutaneous AVR with Edwards SAPIEN Valve (retrograde and antegrade) -- 4:15 p.m. to 4:35 p.m. Ballroom 20 A-C, San Diego Convention Center. Presenter: John G. Webb, St. Paul's Hospital, Vancouver, BC, Canada. -- Session V, Percutaneous Aortic Valve Replacement: Identification of Appropriate Patients: Who Actually is "Inoperable"? -- 4:55 p.m. to 5:15 p.m. Ballroom 20 A-C, San Diego Convention Center. Presenter: Michael J. Mack, Cardiothoracic Surgery Associates of North Texas, Dallas, TX. Wednesday, May 14 -- Emerging Technologies and Techniques Forum: Is Transcatheter Based Aortic Valve Implantation Really Less Invasive than Minimal Invasive Aortic Valve Replacement? -- 7:13 a.m. to 7:26 a.m. Room 25, San Diego Convention Center. Presenters/authors: Mirko Doss, Sven Martens, Stephan Fichtelscherer, Thomas Trepels, Gerhard Wimmer Greinecker, Anton Moritz, Volker Schachinger, Thoracic and Cardiovascular Surgery, J.W. Goethe University Frankfurt, Frankfurt am Main, Germany. -- Emerging Technologies and Techniques Forum: Transapical Transcatheter Aortic Valve Implantation One Year Follow-Up in 19 Patients -- 8:05 a.m. to 8:18 a.m. Room 25, San Diego Convention Center. Presenters/authors: Jian Ye, Anson Cheung, John G. Webb, Daniel R. Wong, Ronald G. Carere, Christopher R. Thompson, Samuel V. Lichtenstein, Cardiothoracic Surgery, University of British Columbia, Vancouver, BC, Canada. About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies. In 2008, Edwards celebrates 50 years of partnering with clinicians to develop life-saving innovations. The company's global brands, which are sold in approximately 100 countries, include CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at http://www.edwards.com/.
Edwards, Edwards SAPIEN, FemTrak, OptiSite and RetroFlex are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Ascendra, CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna, Carpentier-Edwards Physio and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.
