Boston Scientific has completed enrolling the first patient in its REPRISE II clinical trial, designed to assess safety and efficacy of the Lotus Valve system in minimising aortic regurgitation.
The Lotus Valve system is the first transcatheter aortic valve replacement (TAVR) device; it features a pre-loaded stent-mounted tissue valve prosthesis and catheter delivery system used for guidance and percutaneous placement of the valve.
It also incorporates an Adaptive Seal to minimise the incidence of paravalvular regurgitation.
The international, multi-centre study will enrol up to 120 patients with severe calcific aortic stenosis and who are at high surgical risk to study two valve sizes, 23mm and 27mm.
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 five-year follow-up, is expected to complete its enrollment in the first half of 2013.
Monash Medical Centre Monash Heart director and study principal investigator professor Ian Meredith said the centre was encouraged by the promising results of the REPRISE I clinical trial completed earlier in 2012, and was 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 minimised risk of paravalvular leakage, may lead to improved clinical outcomes."
Boston Scientific said the results of the REPRISE II trial were expected to be used to support CE mark approval and other regulatory filings.
Image: Boston Scientific's corporate headquarters in Natick, Massachusetts, US. Photo: courtesy of Boston Scientific.