Boston Scientific has completed enrolling first patient in REPRISE II clinical trial, designed to assess the safety and efficacy of the Lotus Valve system in minimizing aortic regurgitation (leaking).
The Lotus Valve system, which the company claims, is the first transcatheter aortic valve replacement (TAVR) device, features a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system used for guidance and percutaneous placement of the valve.
The new TAVR device also incorporates Adaptive Seal feature which minimizes the incidence of paravalvular regurgitation.
The international, multi-center trial, which will enroll up to 120 patients with severe calcific aortic stenosis and who are at high surgical risk, will study two valve sizes, 23 mm and 27 mm.
In addition, the study will assess other endpoints as recommended by the Valve Academic Research Consortium and regulatory agencies.
The study, which will have a 5-year follow-up, is expected to complete its enrollment in the first half of 2013.
Monash Medical Center Monash Heart director and study principal investigator professor Ian Meredith said the center is encouraged by the promising results of the REPRISE I clinical trial completed earlier in 2012, and is therefore confident about evaluating the safety and performance of the Lotus Valve in a larger patient cohort.
"The Lotus Valve has a number of important features which address some of the limitations observed with the first generation devices," Meredith added.
"The ease of use, predictable and precise positioning, and the ability to fully reposition and retrieve the Lotus Valve offer the operator considerable reassurance and control.
"These features, along with the minimized risk of paravalvular leakage, may lead to improved clinical outcomes."
The company said the results of the REPRISE II trial are expected to be used to support CE mark approval and other regulatory filings.