First Boston Scientific Lotus Valve Implants Completed in Germany

Natick, Mass.-based interventional medical device company Boston Scientific Corporation has successfully completed the first two commercial implants of its Lotus Valve System. The implants took place in a German hospital.

CE Mark approval for the Lotus Valve System was announced October 28 at the Transcatheter Cardiovascular Therapeutics Conference in San Francisco. The company also presented primary endpoint data from the REPRISE II clinical trial at the conference. 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 system is a differentiated second-generation transcatheter aortic valve replacement (TAVR) technology, which consists of a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve. The low-profile delivery system and introducer sheath are designed to enable predictable and precise placement, as well as bi-directional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant. The device also employs an adaptive seal feature designed to minimize the incidence of paravalvular regurgitation.

he Lotus Valve System is available at select centers in Europe with commercial site expansion accelerating as physicians and centers become fully trained. The system is an investigational device in the United States and Japan and is not available for sale in these countries.