Boston Scientific's Lotus Valve System Supported by 6-Month REPRISE II Data

May 21, 2014—Boston Scientific Corporation announced that 6-month data from the REPRISE II clinical trial continue to demonstrate the performance of the company’s Lotus transcatheter aortic valve implantation (TAVI) system. The study is evaluating the Lotus valve system in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement. Professor Ian Meredith, MD, principal investigator of the REPRISE II trial, presented the data at the EuroPCR 2014 congress being held May 20–23 in Paris, France.

The company stated that the REPRISE II results showed that the Lotus valve system delivered sustained safety and effectiveness outcomes out to 6 months, with only 1.1% of patients having moderate paravalvular aortic regurgitation; no severe cases occurred. 

As summarized by Boston Scientific, the key 6-month findings include that the mean aortic valve pressure gradient remained low and stable at 11.4 ± 4.6 mm Hg. The study’s primary device performance endpoint was 30-day mean aortic valve pressure gradient, as assessed by an independent core lab. This endpoint was met with a mean aortic valve pressure gradient of 11.5 ± 5.2 mm Hg at 30 days, which was significantly less than the performance goal of 18 mm Hg (P < .001).

Additionally, 79.8% of patients had no paravalvular aortic regurgitation by independent core lab assessment. In addition, no cases of severe paravalvular aortic regurgitation occurred in any patient at 6 months. The all-cause mortality rate was 8.4%. The disabling stroke rate was 3.4%. No cases of nonstudy valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, or valve-in-valve or ectopic valve placement occurred, reported the company.

Boston Scientific advised that REPRISE II is an ongoing prospective, single-arm study that enrolled 120 patients at 14 sites in Australia, France, Germany, and the United Kingdom. The trial was extended to enroll an additional 130 patients at 16 sites in Australia and Europe; this enrollment is now complete.

The Lotus aortic valve system is a second-generation TAVI technology composed of a preloaded, stent-mounted tissue valve prosthesis and a catheter delivery system for guidance and percutaneous placement of the valve. The Lotus valve system received European CE Mark approval and is available for sale in CE Mark countries. In the United States, the Lotus device is an investigational device and is not available for sale.