News | April 23, 2012

Enrollment Completed in Clinical Trial for Lotus Aortic Valve System

REPRISE I Trial results to be presented at EuroPCR 2012

April 23, 2012 — Boston Scientific Corp. announced it completed enrollment in the REPRISE I clinical trial to evaluate the acute safety of the Lotus Aortic Valve System. It is the first transcatheter aortic valve replacement (TAVR) device of its kind for patients with severe aortic valve stenosis that is both fully repositionable and retrievable prior to release. This prospective, single-arm feasibility study enrolled 11 patients at three sites in Australia. Results from the REPRISE I trial are scheduled to be presented at the EuroPCR Congress in May.

"We are delighted to complete enrollment in this important trial, and pleased that the clinical results will be presented at the forthcoming EuroPCR conference in Paris next month," said Ian Meredith, professor and director of MonashHeart at Monash Medical Center in Melbourne, Australia, and principal investigator of the REPRISE I Trial. "The Lotus Aortic Valve System offers the unique 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."

The primary endpoint of the REPRISE I trial is defined as clinical procedural success without in-hospital major adverse cardiovascular or cerebrovascular events (MACCE) through discharge or seven days post-procedure (whichever comes first). In-hospital MACCE includes death, heart attack, major stroke, and conversion to surgery or repeat procedure due to valve-related dysfunction. Secondary endpoints under study include successful repositioning of the Lotus Valve System (if attempted) and incidence of aortic valve regurgitation (leaking).

The Lotus Aortic Valve System consists of 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 are designed to 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. The device also employs a unique Adaptive Seal feature designed to minimize the incidence of paravalvular regurgitation, which has proven to be a predictor of mortality.

"We are very encouraged by positive feedback from the REPRISE I investigators and look forward to the results of the study," said Keith D. Dawkins, M.D., global chief medical officer for Boston Scientific. "The Lotus Aortic Valve System is a truly differentiated second-generation TAVR technology designed to simplify and improve the entire aortic valve replacement procedure."

Boston Scientific expects to begin enrollment later this year in the REPRISE II study, which is designed to evaluate the safety and performance of the Lotus Aortic Valve System in 120 patients at up to 15 sites in Australia and Europe. Data from the trial will be used to support CE mark and other international regulatory approvals. Enrollment is expected to be completed in the first half of 2013.

The Lotus Aortic Valve System is an investigational device, limited by applicable law to investigational use and not available for sale. The device was developed by Sadra Medical, which Boston Scientific acquired in 2011.

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