Boston Scientific's Lotus TAVR System Meets REPRISE II 30-Day Primary Performance Endpoint

October 31, 2013—Boston Scientific Corporation (Natick, MA) announced that the company's Lotus transcatheter aortic valve replacement (TAVR) system met a key performance measure in the treatment of symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement. The data from the REPRISE II trial were presented as a First Report Investigation by Principal Investigator, Professor Ian T. Meredith, MD, at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California. Prof. Meredith is Director of MonashHeart at Monash Medical Centre in Melbourne, Australia.

According to Boston Scientific, the Lotus valve system met the primary device performance endpoint at 30 days with no severe paravalvular aortic regurgitation. REPRISE II is an ongoing prospective, single-arm study that has enrolled 120 patients at 14 sites in Australia, France, Germany, and the United Kingdom. The trial is being extended to enroll an additional 130 patients at 20 sites in Australia and Europe.

As summarized by the company, the primary device performance endpoint assessed by an independent core lab was met as the 30-day mean aortic valve pressure gradient of 11.5 ± 5.2 mm Hg was significantly (P < .001) less than the performance goal of 18 mm Hg. The primary safety endpoint, defined as all-cause mortality at 30 days, was 4.2%. Independent core lab assessment of paravalvular aortic regurgitation at 30 days indicated no severe regurgitation and one case of moderate regurgitation (1%). In 5.2% of patients, regurgitation was considered trace, and in 78.4% of patients, there was no paravalvular regurgitation at 30 days. There were no instances of nonstudy valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, or valve-in-valve or ectopic valve placement. The disabling stroke rate for the 120 patients at 30 days was 1.7%.

In the company's press release, Prof. Meredith commented, “The results from the REPRISE II trial continue to demonstrate the benefits of the Lotus valve system, particularly the ability to position the valve accurately the first time, while having the advantage of full retrieval if needed. In all 120 patients, the Lotus valve system was successfully implanted and positioned appropriately with negligible aortic regurgitation while reporting low 30-day all-cause mortality and major stroke rates in this sick patient population. This is a testament to the advancement in technology that the Lotus valve system offers.”

On October 31, the REPRISE I trial's 1-year results were published by Prof. Meredith et al online ahead of print by EuroIntervention. REPRISE I, which is a prospective, single-arm feasibility study on patients with severe symptomatic aortic stenosis conducted in Australia, demonstrated sustained safety and performance of the Lotus valve out to 1 year with no new major adjudicated events, as defined by the Valve Academic Research Consortium, and no moderate or severe paravalvular aortic regurgitation in any patient. Prof. Meredith had presented the 1-year REPRISE I results, as well as early REPRISE II data, in May at the EuroPCR 2013 conference in Paris, France.

The company stated that the Lotus valve system is a second-generation TAVR device. Designed for total control, the Lotus system is both fully repositionable and retrievable before release and incorporates the company's Adaptive Seal technology to minimize paravalvular aortic regurgitation. The device has European CE Mark approval and is commercially available in Europe and countries that recognize the CE Mark. The Lotus valve system is an investigational device and not available for sale in the United States, advised Boston Scientific.