NATICK, Mass., Nov. 15, 2013 /PRNewswire/ -- Marking a major step forward in the evolution of Transcatheter Aortic Valve Implantation (TAVI) technology, the first two commercial implants of the Boston Scientific (NYSE: BSX) Lotus™ Valve System have taken place in a German hospital. Prof. Dr. med. Gerhard Schuler and Prof. Dr. med. Axel Linke, both considered TAVI pioneers, led the procedures at the Heart Center - University Hospital Leipzig, Germany. CE Mark approval for the Lotus Valve System was announced October 28, 2013 at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco.
The Lotus Valve System offers a unique and effective alternative treatment for patients with severe aortic stenosis at high risk of surgical valve replacement. It is a next-generation transcatheter aortic valve implantation (TAVI) device designed to give physicians total control throughout the TAVI procedure. The Lotus Valve is comprised of bovine pericardium and a nitinol frame with a central marker to aid in precise positioning. It features a novel Adaptive Seal™ technology to help minimize aortic regurgitation (leaking), a proven predictor of mortality. It is also the first device of its kind that can be fully retrieved, redeployed, or repositioned, including after full valve deployment and prior to release.
"The Lotus Valve System permits very precise positioning of the device and the Adaptive Seal minimizes potential paravalvular leakage," said Professor Schuler. "These are the key differentiating features of this new technology."
Primary endpoint data from the REPRISE II clinical trial were presented at TCT by Prof. Ian Meredith, principal investigator and director of MonashHeart at Monash Medical Centre, Melbourne, Australia. The data demonstrated that the Lotus Valve System was successfully implanted and correctly positioned in all 120 patients, and met the co-primary endpoints of mean aortic valve pressure gradient and all-cause mortality at 30 days. The valve produced impressive clinical results, with no valve malpositioning, migration, or severe embolization, low clinical event rates that were consistent with those reported for other valves, and negligible paravalvular aortic regurgitation at 30 days.The Lotus Valve System comes pre-attached on a transfemoral delivery system and is inserted into the body through a small incision in the leg. Once delivered across the diseased aortic valve, the Lotus Valve System is deployed through a controlled mechanical expansion that is distinct from balloon-expandable or self-expanding valves.