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Boston concludes patient enrolment in Lotus valve system trial

25 April 2012

Boston Scientific

Boston Scientific completed patient enrolment for its Reprise I clinical trial designed to assess the acute safety of the Lotus aortic valve system, used to treat patients with severe aortic valve stenosis.

Developed by Sadra Medical and acquired by Boston, the Lotus aortic valve system features a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve.

The low-profile delivery system and introducer sheath of the device enable predictable and precise placement, as well as bi-directional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant.

In addition, the device consists of an adaptive seal designed to minimise the incidence of paravalvular regurgitation, which has proven to be a predictor of mortality. The prospective single-arm feasibility study enrolled 11 patients at three sites in Australia, with the results from the study anticipated to be reported next month.

The Reprise I trial's primary endpoint is defined as clinical procedural success without in-hospital major adverse cardiovascular or cerebrovascular events (MACCE) through discharge or seven days post-procedure, while secondary endpoints include successful repositioning of the Lotus valve system and incidence of aortic valve regurgitation (leaking).

Ian Meredith, MonashHeart director and principal investigator of the trial at the Monash Medical Centre, Australia, said the Lotus aortic valve system offers the ability to precisely position the valve during deployment, with the added ability to reposition and retrieve the device if necessary.

"The valve functions remarkably early in the deployment process, offering interventional cardiologists greater control over the deployment. We observed virtually no aortic regurgitation in all cases immediately after implantation," Meredith added.

The company plans to commence patient enrolment in the Reprise II study later this year. Data from the trial will be used to support CE mark and other international regulatory approvals.

Image: Boston Scientific's corporate headquarters, located in Natick, Massachusetts, US. Photo courtesy of: Boston Scientific.