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Selasa, 04 Februari 2020 13:34:00

Jean Boulle Group: European Union Approval for Tendyne Transcatheter Mitral Valve

LUXEMBOURG - EQS Newswire - 3 February 2020 - Jean Boulle Medtech Ltd. (the "Company"), founder  of Tendyne Holdings, Inc. ("Tendyne") and a Jean Boulle Group (the "Group") company developing medical technologies that save lives, is pleased to announce that the Tendyne transcatheter mitral heart valve implant which it developed has received CE Mark approval from the European Union.

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." (*).