Boston Scientific, a manufacturer of medical devices, has unveiled six-month results at PCR London Valves from the first 60 patients enrolled in the REPRISE II clinical trial.
REPRISE II is an ongoing prospective, single-arm study evaluating the safety and performance of the Lotus valve system in symptomatic patients with severe aortic stenosis considered at high risk for surgical valve replacement.
The clinical trial results has shown no new valve-related adverse events between 30 days and six months and no cases of moderate or severe paravalvular regurgitation in any patient at six months.
These favorable results are anticipated to help the company in obtaining CE Mark other international regulatory approvals.
Boston Scientific global chief medical officer Dr Keith Dawkins noted the latest results from REPRISE II 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.
"These features help to simplify the implantation procedure and may lead to improved clinical outcomes," Dr Dawkins added.
The Lotus valve system is a transcatheter aortic valve replacement device with an Adaptive seal, designed to minimize aortic regurgitation around the valve.
Boston Scientific anticipates the release of additional REPRISE II data at the up coming Transcatheter Cardiovascular Therapeutics conference in San Francisco.