OR YEHUDA, Israel, Sept. 19, 2015 /PRNewswire/ -- Valtech Cardio, Ltd., an innovator in the development of devices for mitral and tricuspid valve repair and replacement, announces it has received Conformité Européenne (CE) Marking for its Cardioband® Mitral Reconstruction System, (Cardioband), a proprietary implantable mitral reconstruction device with a transfemoral transseptal delivery system for mitral valve repair. The designation was based on the results of a multicenter feasibility trial that demonstrated the safety and effectiveness of Cardioband in mitral valve repair and will allow Valtech to market and sell Cardioband in the European Union. Valtech will officially unveil the Cardioband at the upcoming PCR London Valves meeting, being held September 20 to 22, 2015, in Berlin, Germany.
"This is a significant milestone for Valtech and one we feel will add significantly to the ability of physicians to address a condition that is a major contributor to congestive heart failure," said Amir Gross, founder and CEO of Valtech Cardio. "The Cardioband was specifically designed to facilitate mitral valve repair in a first-line setting while preserving the ability to perform future percutaneous or surgical valve repair and/or replacement, and the results of our multicenter clinical trial really help to demonstrate the success of this device in this indication."
Mitral regurgitation (MR) is a vastly underserved condition in which the mitral valve leaflets fail to close properly, allowing backflow of blood from the left ventricle into the left atrium during systole. Left untreated, severe MR can eventually lead to a meaningful deterioration in cardiac function and, eventually, death. Approximately 4.2 million patients in the U.S. alone are affected by mitral valve disease, which represents a several-billion-dollar global market opportunity.
The Cardioband Mitral Reconstruction System enables surgical-like repair of the mitral valve annulus via a transfemoral, transseptal delivery system, allowing for real-time adjustment on a beating heart. The transcatheter, supra-annular approach does not interfere with the mitral valve leaflets or chordae, and does not preclude subsequent treatment options if they become necessary.
In the multicenter feasibility trial including over 50 patients, Cardioband was shown to significantly reduce annular size, with significant improvement in MR. After 6 months of follow up, 82% of patients (n = 22) were categorized in NYHA Class I-II, with significant improvement of quality of life (Minnesota Living With Heart Failure Questionnaire) score of 38 to 18 [p<0.05]; and had six-minute walk test score of 250 to 322 [p<0.05]). At 12 months' follow-up, 94% of patients (n=17) had sustained MR ≤ 2+.
"Cardioband is a major step forward in the history of mitral valve disease and treatment," said Professor Karl-Heinz Kuck, M.D., Ph.D., Head of Cardiology Department, Asklepios Klinik St. Georg, Hamburg, Germany. "The overall experience with Cardioband therapy is extremely satisfying. We were able to use the technology with all of the patients in the clinical study without a single failure. I really believe that this is the very first technology that can be applied systematically around the world to patients suffering from secondary mitral regurgitation. For me the Cardioband is the only technology that can reproducibly reduce the septo-lateral diameter."
Valtech is planning several events at the London Valves meeting including presentations of clinical data with the Cardioband. On Monday, September 21, at 15:13, Room 4, Prof. Kuck will present the "Percutaneous Annuloplasty for Mitral Valve Repair Multicentre Trial Report."
Additional information about Cardioband, including clinical insights from leading experts in the mitral space, will be presented during a special Valtech sponsored session titled "Cardioband: A New Era of Mitral Valve Repair," being held Tuesday, September 22, Room 2, from 13:00-14:40.
Valtech, which will have a presence at the London Valves meeting at Booth #1, will be holding a training village located at Level 3 room R13. Interested surgeons are encouraged to stop by the booth for additional information.
The company will also sponsor a reception in the Exhibition Hall on Monday, September 21, starting at 18:30.
Cardioband Mitral Reconstruction System
The Cardioband System combines a reconstruction implant, similar to the surgical annuloplasty devices, with a transfemoral transseptal delivery system. Connection of the implant to the mitral annulus is sutureless using specially designed anchors. Reshaping of the mitral annulus to eliminate Mitral Regurgitation (MR) is done under physiological conditions and echocardiographic guidance for optimal results. Cardioband received CE Mark approval after clinical trial results demonstrated the device is a safe and efficacious intervention option for patients with functional mitral regurgitation (FMR).
About Valtech Cardio, Ltd.
Valtech Cardio, Ltd., founded in 2005, is a privately held company specializing in the development of devices for mitral and tricuspid valve repair and replacement. Valtech Cardio has full in-house development, manufacturing, and clinical research capabilities, and over 130 patents and patent applications. The company, comprised of multidisciplinary development teams, works in close collaboration with world-renowned heart specialists to provide the best possible therapy for mitral patients. Funded in part from investments made by HeartWare International, Inc. (Nasdaq: HTWR) and other private investors, Valtech Cardio, Ltd., is headquartered in Or Yehuda, Israel. For more information, visit the company's website: www.valtechcardio.com.
SOURCE Valtech Cardio, Ltd.