The Lotus device was put on the market as soon as the approval came through, Natick, Mass.-based Boston Scientific said.
The Lotus valve is the only aortic valve device that allows physicians to assess its final position before release, according to a press release, "while maintaining the ability for the physician to reposition or fully resheath and retrieve the valve. It’s designed to minimize the aortic regurgitation that’s plagued earlier TAVI offerings.
Last month Boston Scientific touted promising early results from a study of its Lotus transcatheter aortic valve implantation system, noting low rates of paravalvular leakage and adverse events at the 6-month mark. Results were analyzed for the 1st 60 patients enrolled in the company’s Reprise II clinical trial, a 120-patient study recognized for "Best Abstract 2013" at the PCT London Valves conference.
"The Lotus valve system offers patients a new, effective treatment option and provides physicians unmatched positioning and placement capabilities," Tom Fleming, vice president & general manager of Boston Scientific’s structural heart segment, said in prepared remarks. "It’s the culmination of a decade of research and development and demonstrates our commitment to innovations that make a difference in the lives of patients."