US-based medical device manufacturer Boston Scientific has reported positive six-month results from the first 60 patients enroled in the REPRISE II clinical trial, designed to evaluate 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 Lotus transcatheter aortic valve replacement device with the company's Adaptive seal is designed to minimise aortic regurgitation and is both fully repositionable and retrievable before release.
The data demonstrated excellent results with no new valve-related adverse events between 30 days and six months.
There were also no cases of moderate or severe paravalvular regurgitation in any patient at six months.
The data was presented at PCR London Valves and formally received the honor of Best Abstract 2013.
Monash Medical Centre MonashHeart director in Melbourne, Australia, and principal investigator of the REPRISE II trial professor Ian Meredith said the Lotus Valve System provides the operator a high-level of control to enable precise positioning and accurate deployment.
"The results from the first 60 patients of the REPRISE II trial are very impressive, especially with no patients presenting with moderate or severe paravalvular regurgitation at six months," Meredith said.
The REPRISE II trial of the Lotus system is an ongoing, prospective, single-arm study that has completed enrolment of 120 patients at 14 sites in Australia, France, Germany, and the UK.
All patients had severe symptomatic aortic stenosis and were considered high risk for surgical valve replacement. REPRISE II is being extended to enrol an additional 130 patients at 20 sites in Australia and Europe.
Boston Scientific global chief medical officer Dr Keith Dawkins said the latest results from REPRISE II highlighted how the Lotus 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 said.
The company plans to release additional REPRISE II data at the upcoming TCT conference and expects to use the results of REPRISE trials in achieving CE Mark and other international regulatory approvals.
According to GlobalData estimates, transcatheter heart valves market in the US which was valued at $280m in 2012 is expected to grow at a CAGR of 25.3% to reach $1.36bn by 2019.
Image: The Lotus Valve System. Photo: courtesy of Boston Scientific Corporation.