Nieuwe mitralisklep van Edwards Lifescience

Het Bedrijf Edwards Lifesciences(NYSE: EW), de wereldleider hartkleptechnologieën, kondigt de Europese lancering aan een nieuwe therapie van de mitralisklepreparatie die is ontworpen voor een reparatie van lekkende mitralisklepklep bij patiënten met congestive heart failure. De GeoFormannuloplasty ring van Edwards is uniek. De driedimensionele vorm is kenmerkend en is blijkt zeer succesvol te zijn bij de behandeling die door cardiomyopathie wordt veroorzaakt.De functie van het linkerventrikel, blijkt te verbeteren. De resultaten worden deze week gepresenteerd op de jaarlijkse vergadering van de European Association for Cardio-thoracic Surgery (EACTS). De cardiomyopathie is een vaak voorkomende vorm van congestiehartverlamming die tienduizenden mensen jaarlijks treft. In de presentatie van GeoForm: Een Nieuwe Valvular Oplossing voor een Ventriculair Probleem, ‘ Steven F. Bolling, M.D., professor of surgery and director of the University of Michigan Health System’s Mitral Valve Clinic, presenteerd de resultaten van een prospectieve studie van 16 congestive heart failure patients, wiens aan mitralisklepregurgitation is toe te schrijven aan vervorming. Zes maanden nadat de patiënten ‘ mitraliskleppen chirurgisch werden vervangen door Edwards GeoFormannuloplasty ring, werd de mitralisklepregurgitationgeëlimineerd en het linkerventrikel werd genormaliseerd. Edwards Lifesciences ontwikkelde de ring GeoForm met Prof. Ottavio M. Alfieri, M.D., van St. Raffaele Hospital in Milaan, Italië en Dr. Bolling. Hieronder het officiele persbericht van Edwards Lifescience Corporation
Edwards Lifesciences Corporation (NYSE: EW), the world leader in heart valve technologies, announced the European and U.S. launch of a new mitral valve repair therapy designed to treat the leaky mitral valve of patients suffering from congestive heart failure. The Edwards GeoForm annuloplasty ring, which features a unique, three-dimensional shape, has been shown to successfully treat mitral valve regurgitation caused by cardiomyopathy, and improve the function of the left ventricle, according to a presentation delivered today at the annual meeting of the European Association for Cardio-thoracic Surgery (EACTS). Cardiomyopathy is a common form of congestive heart failure that affects tens of thousands of people annually.

In his presentation, ‘GeoForm: A New Valvular Solution for a Ventricular Problem,’ Steven F. Bolling, M.D., professor of surgery and director of the University of Michigan Health System’s Mitral Valve Clinic, presented results from a prospective study of 16 congestive heart failure patients, all of whom were suffering from mitral valve regurgitation due to distortion of their heart’s left ventricle. Six months after the patients’ mitral valves were surgically repaired with the Edwards GeoForm annuloplasty ring, their mitral valve regurgitation, or backflow of blood caused by a leaking valve, was eliminated and the left ventricle was reformed.

Edwards Lifesciences developed the GeoForm ring with Prof. Ottavio M. Alfieri, M.D., of St. Raffaele Hospital in Milan, Italy and Dr. Bolling.

‘While still early, these results clearly demonstrate excellent outcomes for patients suffering from severe mitral valve regurgitation and left ventricular dysfunction,’ said Dr. Bolling. ‘We believe this heart valve repair ring will help break the cycle of mitral valve regurgitation and left ventricular distortion that can be caused by certain forms of congestive heart failure.’

‘The Edwards GeoForm repair ring creates a unique option for surgeons treating patients with mitral valve regurgitation,’ said Patrick Verguet, Edwards’ corporate vice president, Europe. ‘Edwards Lifesciences invests more resources than any other company in heart valve therapy research and development, and it is especially rewarding when our collaboration with the global clinical community produces such positive results as the GeoForm ring. We believe this new ring is an important addition to our extensive portfolio of disease-specific heart valve repair therapies, and will further extend our leadership in the field.’

Mitral Valve Regurgitation Has Serious Consequences

According to the American Heart Association, nearly five million people in the United States have congestive heart failure, with approximately one in five people age 40 years and older estimated to develop the disease in their lifetime. A number of these patients develop cardiomyopathy, a weakening of the heart muscle that distorts and enlarges the left ventricle, thereby inhibiting the mitral valve’s leaflets from properly closing and causing blood to flow backward through the heart. As reported by Dr. Bolling in a 1998 study published in the Journal of Thoracic and Cardiovascular Surgery, failing to address the onset of mitral valve regurgitation by treating a leaky mitral heart valve can compound the condition and increase the likelihood of heart failure.

Patients suffering from severe mitral regurgitation also are five times more likely to die of a heart problem, and six times more likely to have heart failure or some other serious cardiac problem than a healthy person, according to an article published earlier this year in the New England Journal of Medicine. Maurice Enriquez-Sarano, M.D., professor of medicine at the Mayo Clinic, director of the Mayo Clinic’s valvular heart disease clinic, and the study’s lead author, estimates that of the approximately 2.7 million Americans who have notable mitral valve leakage, about 600,000 are probable candidates for early intervention, such as surgical heart valve repair.

‘The data validate what we’ve believed all along: a large untreated population of heart valve patients could be helped by undergoing earlier heart valve repair,’ said Anita B. Bessler, Edwards’ corporate vice president of Global Franchise Management. ‘This is why we remain so committed to pioneering innovative heart valve therapies designed to specifically treat the large number of unaddressed patients.’

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, Fogarty, LifeStent, PERIMOUNT and Swan-Ganz. Additional company information can be found at www.Edwards.com.

Edwards and GeoForm are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, Carpentier-Edwards, Cosgrove-Edwards, Fogarty, PERIMOUNT, and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark Office. LifeStent is a trademark of Edwards Lifesciences AG and is registered in the U.S. Patent and Trademark Office.

This news release includes forward-looking statements that involve risks and uncertainties, including those related to the expectation that Edwards’ GeoForm ring can gain broad acceptance and further extend the company’s leadership in mitral valve repair and replacement therapies; that there is a large untreated population of heart valve patients that could benefit from Edwards’ products; and other risks detailed in the company’s filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.

Website: www.Edwards.com

Rob