CE Mark for Boston Scientific’s Lotus™ TAVI System

It’s TCT2013 this week. Nice timing then for Boston Scientific, with the news that it has gained CE Mark approval for its Lotus™ Transcatheter Aortic Valve Implant (TAVI). The device will be indicated as a treatment alternative for patients with severe aortic stenosis at high risk with surgical valve replacement.

Background

The European regulatory approval of Lotus has been expected, news as far back as July covering Boston Scientific’s tie up with Sorin over its manufacture (Sorin will make key components), with hints that CE Marking was not far away.

Even the language being used in items about new transcatheter aortic valves is starting to sound familiar. You see, it’s all about making a tricky procedure progressively easier and with more reliable outcomes than could be achieved with the earlier entrants into the market.

Boston Scientific says its Lotus Valve System is designed to provide physicians increased control during implantation and to help provide a more precise, predictable procedure. The company says it is the only aortic valve device that can be assessed in its final position prior to release, while maintaining the ability for the physician to reposition or fully resheath and retrieve the valve, although we seem to recall a German company called Transcatheter Therapeutics, telling us the same thing about their offering last week. The Lotus Valve System also incorporates a unique Adaptive Seal™ technology designed to minimize aortic regurgitation, a proven predictor of mortality… and a target for the other device developers as well.

Boston Scientific is making the Lotus Valve System immediately available to select centers in Europe, with commercial site expansion accelerating as physicians and centers become fully trained.

Physician comments

“The ability to initially position the Lotus Valve precisely and, if needed, to easily reposition or fully retrieve the valve provides the operator with remarkable control,” said Professor Ian Meredith, director of MonashHeart at Monash Medical Centre inMelbourne, Australia, and principal investigator of the REPRISE II trial. “Combined with early and often complete elimination of aortic regurgitation as observed in REPRISE II, the unique features of the Lotus Valve technology represent a significant step forward in the percutaneous treatment of eligible patients with severe symptomatic aortic stenosis.”

“Results from the REPRISE II trial highlight the promise behind the Lotus Valve System, especially related to avoiding moderate or severe paravalvular leaks,” said Dr. Nicolas M. Van Mieghem, M.D., Erasmus Medical Center in Rotterdam, The Netherlands. “In addition to providing a new treatment option for TAVR, the Lotus Valve has the potential to improve clinical outcomes by minimizing paravalvular leaks.”

Company comments

“The Lotus Valve System offers patients a new, effective treatment option and provides physicians unmatched positioning and placement capabilities,” said Tom Fleming, vice president and general manager, Structural Heart, Boston Scientific. “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.”

Source: Boston Scientific Corporation, PR Newswire