US-based Boston Scientific has obtained CE Mark approval for its Lotus valve system, a transcatheter aortic valve replacement (TAVR) device designed to treat patients with severe aortic stenosis who are at high risk with surgical valve replacement.
Incorporating Adaptive Seal technology, the Lotus valve system minimizes aortic regurgitation (leaking), a proven predictor of mortality.
Boston Scientific's Lotus valve system is available in a 23mm and 27mm size and it can treat patients with aortic annulus sizes from 20-27 mm.
The TAVR device comes pre-loaded on a transfemoral delivery system that is inserted through a small incision in the leg.
The lotus valve system offers precise positioning and placement, giving physicians unprecedented control during implantation.
Boston Scientific claims that 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.
According to the six-month data presented at the PCR London Valves course in September 2013, the device met the primary performance endpoint for the first 60-patient cohort and was successfully implanted in all patients with no cases of severe paravalvular regurgitation.
In 76.1% of patients there was no corelab adjudicated paravalvular regurgitation at six months.
Boston Scientific Structural Heart vice president and general manager Tom Fleming noted the Lotus valve system offers patients a new, effective treatment option and provides physicians unmatched positioning and placement capabilities.
"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," Fleming added.
The TAVR device is immediately available to select centers in Europe, with commercial site expansion accelerating as physicians and centers become fully trained.
It is an investigational device in the US and Japan and is not available for sale in the two countries.
