Massachusetts medical device giant Boston Scientific (NYSE:BSX) touted promising early results from a study of its Lotus transcatheter aortic valve implantation system, noting low rates of paravalvular leakage and adverse events at the 6-month mark.
Results were analyzed for the 1st 60 patients enrolled in the company’s REPRISE II clinical trial, a 120-patient study expected to lead to CE Mark approval in the European Union and regulatory approvals elsewhere around the world. The study was given an award this week, recognized for "Best Abstract 2013" at the PCT London Valves conference.
"The latest results from REPRISE II underscore the promising and unique technology behind the Lotus Valve System, demonstrating how the Lotus Valve System can offer a new treatment alternative for patients with severe aortic valve disease," global chief medical officer Dr. Keith Dawkins said in prepared remarks. "These features help to simplify the implantation procedure and may lead to improved clinical outcomes."
At 60 days about a quarter of patients experienced mild paravalvular leakage, or aortic regurgitation, and there were zero cases of moderate or severe leakage, according to a press release. Assessments showed "significant improvement in heart failure symptoms" and there were no new adverse events between 30 days and 6 months. The medtech titan plans to release additional REPRISE II results later this year.
The study includes patients over the age of 70 who have severe calcific aortic stenosis but are considered at too high a risk to undergo surgery. The Lotus device, which Boston Scientific acquired in the 2011 with the $450 million buyout of Sadra Medical, is designed to minimize valve leakage post-implantation. The earlier Reprise I study found no moderate or severe leakage after valve placement or at patient discharge from the hospital.
BSX shares were relatively flat this morning, trading down by 0.4% to $11.87 as of about 11:20 a.m.