Boston Scientific reports positive Lotus valve trial data

Boston Scientific has reported positive data from Reprise II, a clinical trial assessing the safety and efficacy of its Lotus Valve System.

Results from the first 60 patients enrolled in the trial demonstrate the effectiveness of the device in the treatment of symptomatic patients with severe aortic stenosis considered at high risk for surgical valve replacement.

No new valve-related adverse events were reported between 30 days and six months, nor were there any cases of moderate or severe paravalvular regurgitation in any patient after half a year.

The Lotus Valve System is currently restricted to investigational use only, with results from the Reprise clinical trial programme set to be used to support CE Mark and other international regulatory approvals.

Dr Keith Dawkins, global chief medical officer at Boston Scientific, said the results "underscore the promising and unique technology behind the Lotus Valve System, demonstrating how the Lotus Valve System can offer a new treatment alternative for patients with severe aortic valve disease".

This comes after the firm earlier this month completed patient enrolment for Evolve II, a new trial designed to support key regulatory approvals of its Synergy stent system.