Boston Scientific Says Lotus Meets Co-Primary Endpoints

Marking a major step forward inthe 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. GerhardSchuler and Prof. Dr. med. Axel Linke, both considered TAVI pioneers, led theprocedures at the Heart Center - University Hospital Leipzig, Germany.  CEMark approval for the Lotus Valve System was announced October 28, 2013 at theTranscatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco.The Lotus Valve System offers a unique and effective alternative treatment forpatients with severe aortic stenosis at high risk of surgical valvereplacement.  It is a next-generation transcatheter aortic valve implantation(TAVI) device designed to give physicians total control throughout the TAVIprocedure. The Lotus Valve is comprised of bovine pericardium and a nitinolframe with a central marker to aid in precise positioning.  It features anovel Adaptive Seal™ technology to help minimize aortic regurgitation(leaking), a proven predictor of mortality.  It is also the first device ofits kind that can be fully retrieved, redeployed, or repositioned, includingafter full valve deployment and prior to release. "The Lotus Valve System permits very precise positioning of the device and theAdaptive Seal minimizes potential paravalvular leakage," said ProfessorSchuler.  "These are the key differentiating features of this new technology."Primary endpoint data from the REPRISE II clinical trial were presented at TCTby Prof. Ian Meredith, principal investigator and director of MonashHeart atMonash Medical Centre, Melbourne, Australia.  The data demonstrated that theLotus Valve System was successfully implanted and correctly positioned in all120 patients, and met the co-primary endpoints of mean aortic valve pressuregradient and all-cause mortality at 30 days.  The valve produced impressiveclinical results, with no valve malpositioning, migration, or severeembolization, low clinical event rates that were consistent with thosereported for other valves, and negligible paravalvular aortic regurgitation at30 days.The Lotus Valve System comes pre-attached on a transfemoral delivery systemand is inserted into the body through a small incision in the leg.  Oncedelivered across the diseased aortic valve, the Lotus Valve System is deployedthrough a controlled mechanical expansion that is distinct fromballoon-expandable or self-expanding valves."The controlled mechanical expansion and early functioning of the valvefacilitate precise positioning on the first attempt, and the ability to fullyor partially recapture the valve, if necessary, provides additional assurancethat the valve will be ideally positioned at the end of the procedure," saidDr. Linke. The Lotus Valve System is available at select centers in Europe withcommercial site expansion accelerating as physicians and centers become fullytrained.  The valve is available in a 23mm and 27mm size, treating patientswith aortic annulus sizes from 20mm to 27mm.  The Lotus Valve System is aninvestigational device in the United States and Japan and is not available forsale in these countries."Completing our first commercial implants marks a key step forward in offeringan advanced new technology in Europe.  The Lotus Valve System has beendesigned to give the physician increased control during implantation and tohelp provide a more precise, predictable procedure," said Tom Fleming, vicepresident and general manager, Structural Heart, Boston Scientific.  "Webelieve the Lotus Valve is an important treatment alternative for severeaortic valve disease patients at high risk for surgical valve replacement." To view and download an image of the Lotus Valve System, click here.