WASHINGTON, May 8 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation , the world leader in the science of heart valves, today announced the first clinical study results of the recently introduced Edwards Myxo ETlogix annuloplasty ring. The study results showed that the ring, designed specifically to treat patients with myxomatous disease, reduced mitral regurgitation (MR) in patients who underwent the surgery to repair their diseased mitral valves. Additionally, the Company announced the European launch of its Carpentier-Edwards PERIMOUNT Magna Ease aortic valve to complement its robust tissue valve product line.
“The Edwards Myxo ETlogix ring and the Carpentier-Edwards PERIMOUNT Magna Ease both demonstrate our ongoing commitment to product innovations that improve patient outcomes,” said Anita Bessler, Edwards’ corporate vice president, heart valve and cardiac surgery systems. “By combining our advanced technology with enhanced ease of use, we can now provide surgeons with additional options that facilitate implantation.”
European Launch of Magna Ease Aortic Valve
The Carpentier-Edwards PERIMOUNT Magna Ease aortic valve, the newest addition to Edwards’ industry-leading tissue valve line, adds improved ease of use to the excellent hemodynamic performance of the Magna valve platform. The Magna Ease valve is built on the proven performance of PERIMOUNT valves, with long-term durability of up to 20 years. The lower profile of the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve offers easier insertion through small incisions or in small aortic roots, and also provides a better option in treating patients with irregular or challenging anatomies. The product has received CE Mark approval for Europe, but it is not available for sale in the United States.
Edwards Myxo ETlogix Annuloplasty Ring Study Results
According to the study results, surgical treatment of myxomatous (Myxo) mitral disease with the Edwards Myxo ETlogix annuloplasty ring reduces MR. The repair technique also simplified what is typically an intricate surgical procedure.
The clinical study presentation, titled “Novel Surgical Approach to Myxomatous Mitral Valve Repair,” will be presented at the 87th annual meeting of the American Association for Thoracic Surgery (AATS) in Washington, D.C., on Wednesday, May 9, by Patrick McCarthy, M.D. Dr. McCarthy is the chief of the division of cardiothoracic surgery at Northwestern Memorial Hospital in Chicago and also serves as co-director of Northwestern Memorial’s Bluhm Cardiovascular Institute. McCarthy is also a Heller-Sacks professor of surgery at Northwestern University’s Feinberg School of Medicine, as well as a paid consultant to Edwards Lifesciences.
The study focused on two groups of Myxo MR disease patients (128 patients total) who underwent primary mitral valve repair (MVR). The control group of patients underwent MVR for Myxo MR with conventional annuloplasty rings and surgical techniques. The second group was treated with the Edwards Myxo ETlogix ring. The results demonstrated effective repair of MR in all patients.
“Myxomatous repair procedures are very complex and require intricate valve leaflet resections that are tailored to each individual patient,” said McCarthy. “Since many Myxo patients are younger, typically in their mid-fifties, they often receive a mechanical valve, which requires lifelong anticoagulation therapy. The Myxo ETlogix procedure offers surgeons a simpler, more straightforward alternative that also frees patients from the lifestyle restrictions associated with anticoagulation therapy.”
Edwards ONE Program: Simulator Training and Education on Undertreatment of Patients
Edwards will also feature simulator training during the AATS meeting (booth #0405) as part of its Edwards ONE Program, a cardiovascular education program designed to help prepare surgeons for future technology innovations. Edwards ONE provides cardiac surgeons with exposure to innovative heart valve technologies, disease treatment options and basic transcatheter training through its Basic Endovascular Skills Training, or BEST(TM) course. This curriculum provides surgeons with an intensive simulator-based learning experience for introductory guidewire, catheter and fluoroscopic imaging skills, utilizing the SimSuite(R) Education System.
The Edwards ONE program also includes an educational component that addresses the undertreatment of aortic stenosis (AS) in the U.S. It is estimated that for every patient who receives an aortic valve replacement, there is another who goes untreated, even though 50 percent of AS patients with severe symptoms will die within two years. Greater awareness of the disease and treatment options can lead to improved patient outcomes.
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, peripheral 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, LifeStent, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at http://www.edwards.com.
About Medical Simulation Corporation
Medical Simulation Corporation (MSC) is the recognized healthcare industry leader in providing full-service training and education services. Customers include medical product manufacturers, medical societies, and hospital personnel, including clinical specialists, sales representatives, physicians, nurses, and technicians. Through MSC’s network of dedicated hospital-based SimSuite Education Centers and mobile training platforms, MSC can provide customized training services to any location in the U.S. to serve customers, clinical staff, and employees. For more information, please visit www.medsimulation.com.
This news release includes forward-looking statements that involve risks and uncertainties, including those related to the results from the clinical studies for the Myxo ETlogix annuloplasty ring, and the European launch of the PERIMOUNT Magna Ease aortic valve, 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.
Edwards, FloTrac, Myxo ETlogix and Magna Ease are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, Carpentier-Edwards, Cosgrove-Edwards, Fogarty, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office. LifeStent is a trademark of Edwards Lifesciences AG and is registered in the United States Patent and Trademark Office.
SimSuite is a registered trademark of Medical Simulation Corporation. BEST and BEST Program are trademarks of Medical Simulation Corporation.
Edwards Lifesciences Corporation
CONTACT: Media, Nolan Taira, +1-949-250-5070, or Investors, David K.Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation
