Jean Boulle Group
Jean Boulle Group: European Union Approval for Tendyne Transcatheter Mitral Valve
DGAP-News: Jean Boulle Group
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Jean Boulle Group European Union Approval for Tendyne Transcatheter Mitral Valve This heart valve implant will now be available throughout the European Economic Area to patients with mitral regurgitation (“MR”). MR is the most common disease affecting heart valves[1] and is a debilitating, progressive and life-threatening condition in which the heart’s mitral valve does not close completely, causing blood to flow backward and leak into the left atrium of the heart. Left untreated, MR can lead to heart failure and death. Implanted in a beating heart, the Tendyne valve enables a significantly less invasive procedure for mitral valve treatment than open heart surgery. Traditional open-heart valve surgery is highly invasive, requiring the surgeon to make a 6 to 8 inch incision along the middle of the chest, cutting through the breastbone and stopping the heart in an operation lasting approximately 8 hours, with significant intensive care required during recovery in hospital and subsequent weeks at home. By comparison the Tendyne valve procedure lasts around 1.5 hours with patients expected to be discharged from hospital within 3 days. Current trial results have shown a high level of procedural safety with 98.9% of Tendyne patients in this very ill patient group experiencing elimination of MR at discharge and through one-year after discharge. Commenting on today’s announcement, Mr Jean-Raymond Boulle, Chairman and CEO of the Group said: “I am delighted that the Tendyne team behind the breakthrough mitral valve can today reflect on the thousands of lives which will be transformed for the better. Patients with MR in Europe can now avoid open-heart surgery and receive treatment for what otherwise would be an inoperable condition. “Our mitral valve invention will lead to massive associated reductions in the treatment and costs of care borne by patients, healthcare providers and insurers in this billion-dollar healthcare segment. “Tendyne’s success story illustrates the foresight, skills, determination and investment commitment of the Jean Boulle Medtech team. We continue to innovate and to support world class physicians and engineers at research and development facilities in Minnesota and New York U.S.A. as well as in Austria and Holland.” Details of Jean Boulle Group’s Tendyne Acquisition by Abbott Laboratories In September 2015 the Jean Boulle Group announced that an agreement had been reached for Abbott Laboratories (NYSE: ABT) (“Abbott”) to acquire Tendyne from Jean Boulle Medtech Ltd and other Tendyne shareholders for a total consideration of US$400million excluding Abbott’s existing 10% of the company. Abbott paid an initial US$250 million under the terms of the acquisition and agreed to two future payments totaling US$150million contingent upon meeting certain regulatory requirements, as well as completing a designated number of successful transcatheter mitral valve replacements in patients. Jean Boulle Medtech’s range of medical technologies VDYNE Jean Boulle Medtech founded VDYNE, a medical device company focused on the development of a transcatheter replacement valve to treat patients suffering from tricuspid regurgitation (“TR”). VDYNE is currently undertaking late stage pre-clinical testing, including the completion of good laboratory practice compliance and a range of mandatory pre-clinical testing steps. Trained Therapeutix Discovery Jean Boulle Medtech founded Trained Therapeutix Discovery (“TTxD”). Under an exclusive license from the Ichan School of Medicine at Mount Sinai TTxD is developing nanobiologics that regulate the innate immune system to effectively treat cancer and other major diseases. ENDS For more information please contact: Audrey Richardson Michael Oke/ Andy Mills Notes to Editors: Nearly one in ten people aged over 75[2] have moderate to severe mitral regurgitation and the condition can raise the risk of irregular heartbeats, stroke and heart failure. Patient outcomes have been positive with the Tendyne(TM) system successfully implanted in 97 of the first 100 patients[3]. Global trial results to date have demonstrated excellent procedural safety and have shown 98.9% of Tendyne(TM) patients experienced MR elimination at discharge which was sustained through one-year in this very sick patient group.[4] Structural heart conditions affect millions of adults and thousands of newborns each year[5],[6]. The structural heart medical device market represents the largest, fastest-growing cardiovascular device market opportunity today[7] and forecasted to be $10+ billion by 2025. The transcatheter mitral repair and replacement market alone is projected to become a multi-billion dollar opportunity by 2025[8].[1] Source: Abbott Laboratories Press Release 30 January 2020: Tendyne(TM) Device Receives World’s First CE Mark for Transcatheter Mitral Valve Implantation Available
03.02.2020 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |