Boston Scientific Touts Positive 6 Month Data from Lotus™ TAVI Study

Boston Scientific Corporation is another of the main protagonists in what is going to be an interesting battle for supremacy over the next few years in the Transcatheter Aortic Valve Implant (TAVI) market. New data presented at EuroPCR 2014 in Paris suggests impressive performance at six months for the Lotus™ Valve System, with 79.8 percent of patients showing no paravalvular aortic regurgitation at six months with no cases of severe paravalvular aortic regurgitation in any patient.

Background

The Lotus Transcatheter Aortic Valve System is another of those trying to claim second-generation status, mainly due to the potential for it to be re-sheathed and repositioned until precisely positioned. Also it features the unique Adaptive Seal™ designed to minimize the incidence of paravalvular regurgitation.

REPRISE II is an ongoing prospective, single-arm study that enrolled 120 patients at 14 sites in Australia, France, Germany and the UK. The trial was extended to an additional 130 patients at 16 sites in Australia and Europe. The study is evaluating the Lotus Valve System in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement.

The data were presented by Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial. 

Results from the trial demonstrated that the Lotus Valve System delivered sustained safety and effectiveness outcomes out to six months, with only 1.1 percent of patients having moderate paravalvular aortic regurgitation. No severe cases occurred.

The primary device performance endpoint of 30-day mean aortic valve pressure gradient, as assessed by an independent core lab, was met as the 30-day mean aortic valve pressure gradient of 11.5 +/- 5.2mmHg was significantly less than the performance goal of 18 mmHg (P<0.001). At six months, the mean aortic valve pressure gradient remained low and stable at 11.4 +/- 4.6 mmHg.

At six months 79.8 percent of patients had no paravalvular aortic regurgitation (PR) as assessed by independent core lab assessment. In addition, no cases of severe paravalvular aortic regurgitation occurred in any patient at six months. For comparison, the Direct Flow Valve yielded figures of 77 percent of patients with no or trace levels of PR at one year.

The all-cause mortality rate was 8.4 percent with a disabling stroke rate of 3.4 percent.

No cases of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, valve-in-valve or ectopic valve placement occurred.

Company comments

“These new results from the REPRISE II clinical trial program underscore the unique technology behind the Lotus Valve System,” said Keith Dawkins, M.D., global chief medical officer, Boston Scientific. “These features are designed to provide a predictable implantation procedure and may result in improved clinical outcomes. The Lotus Valve offers a novel TAVI option for patients with severe aortic valve disease considered at high risk for surgical valve replacement.”

Regulatory status

The Lotus Valve System has CE Mark approval and is available for sale in CE Mark countries. In the U.S., the Lotus Valve System is an investigational device and not available for sale.

Source: Boston Scientific Corporation, PR Newswire

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