REPRISE I Data Presented for Boston Scientific's Lotus TAVR Device

May 15, 2012—Boston Scientific Corporation (Natick, MA) announced that results from the REPRISE I trial were presented at the EuroPCR 2012 conference in Paris. REPRISE is evaluating the acute safety of the transcatheter Lotus aortic valve system in patients with severe aortic valve disease. The data demonstrated successful deployment of the valve in all patients with virtually no paravalvular regurgitation after valve placement or at discharge, advised the company.

As detailed by the company's press release, REPRISE I is a prospective, single-arm feasibility study that enrolled 11 patients at three sites in Australia. All patients had severe symptomatic aortic stenosis and were considered at high risk for surgical valve replacement.

The primary endpoint is defined as successful device implantation without in-hospital major adverse cardiovascular or cerebrovascular events (MACCE) through discharge or 7 days after the procedure (whichever comes first). In-hospital MACCE includes death, heart attack, major stroke, and conversion to surgery or repeat procedure because of valve-related dysfunction.

The REPRISE investigators reported no in-hospital MACCE in 91% (10 of the 11) of patients. One stroke and no deaths were observed. No moderate or severe paravalvular regurgitation was present after valve placement or at discharge.

Prof. Ian Meredith, MBBS, PhD, Director of MonashHeart, at Monash Medical Centre in Melbourne, Australia, serves as Principal Investigator of the REPRISE I.

In Boston Scientific's announcement, Prof. Meredith commented, “Perhaps the most impressive feature of the Lotus valve system in this study was the ability to precisely position the valve on the first attempt, eliminating the need for repositioning, although this capability was available if needed. Another striking feature was that the valve operated early in the deployment process, providing us some comfort and time to consider the valve position, as well as the immediate and almost complete obliteration of aortic regurgitation even in patients who had moderately severe aortic regurgitation after balloon valvuloplasty. In this regard, I think the Lotus valve technology is somewhat unique.”

Boston Scientific stated that the Lotus system is a differentiated second-generation TAVR technology, which consists of a preloaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve. The device also employs the company's Adaptive Seal, which minimizes the incidence of paravalvular regurgitation.

The company advised in its press release that the Lotus aortic valve system is an investigational device and is not available for sale. The device was developed by Sadra Medical (Los Gatos, CA), which Boston Scientific acquired in 2011.

Data from the company's REPRISE II trial will evaluate the safety and performance of the Lotus device in 120 patients at up to 15 sites in Australia and Europe and are expected to be used to support CE Mark and other international regulatory approvals. Enrollment is expected to be completed in the first half of 2013, stated Boston Scientific.