Boston Scientific Lotus Aortic Valve System Demonstrates Strong Performance, Safety at Six Months
Only 1.1 percent of patients experienced moderate paravalvular aortic regurgitation; no severe cases occurred.
Boston Scientific REPRISE II Clinical Trial Six-month Results Lotus Valve .
Further validating its advanced transcatheter aortic valve implantation (TAVI) technology, the Boston Scientific Corp. Lotus Valve System continued to demonstrate impressive performance at six months, according to new data presented at EuroPCR 2014 in Paris.
Results from the REPRISE II clinical 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 (leaking). No severe cases occurred. The data were presented by Prof. Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial. The study is evaluating the Lotus Valve System in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement.
In REPRISE II, the key six-month findings include the following:
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.
An impressive 79.8 percent 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 six months.
The all-cause mortality rate was 8.4 percent.
The disabling stroke rate was 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.
"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."
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 an additional 130 patients at 16 sites in Australia and Europe. Enrollment in this extension of REPRISE II is now complete.
