Boston Scientific (NYSE:BSX) enrolled the 1st patient in a new trial of its Lotus transcatheter aortic valve system, expecting to use the results to support a bid for European CE Mark and other international regulatory approvals.
The new study, Reprise II, will ultimately involve up to 120 patients at 15 centers in Australia, France, Germany and the U.K, according to a company statement.
"We were encouraged by the promising results of the Reprise I clinical trial completed earlier this year and we are therefore very confident about evaluating the safety and performance of the Lotus Valve in a larger patient cohort," Reprise II principal investigator Ian Meredith said in prepared remarks.
Researchers will implant the Lotus in a cohort of patients over the age of 70 with severe calcific aortic stenosis who are considered at too high a risk to undergo surgery. The study will evaluate 2 valve sizes, 23 mm and 27 mm, and follow patients for 5 years following the procedure. Researchers will also assess endpoints recommended by the Valve Academic Research Consortium and other regulatory agencies, according to a press release.
"There is a high need for continued evolution of device technology to treat people with severe aortic valve disease," Boston Scientific global chief medical officer Dr. Keith Dawkins said in prepared remarks. "We are looking forward to advancing the Boston Scientific valve program with Reprise II, as we believe the Lotus Valve System is a unique technology that will offer interventional cardiologists greater precision and control in deployment which, in effect, may simplify the implantation procedure and lead to improved patient outcomes."
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.
The Reprise I study included 11 patients at 3 Australian sites, with 1 incident of major in-hospital adverse cardiovascular or cerebrovascular event, 1 stroke and no deaths.
The Lotus system has investigational device exemption in the U.S., where competition in heart valves is tough – and expected to get tougher.
Medtronic‘s (NYSE:MDT) CoreValve TAVI was 1st on the global market, hitting European shelves in 2007. Edwards Lifesciences (NYSE:EW) wasn’t far behind, putting its Sapien TAVI in the EuroZone a few months later and beating CoreValve to the U.S. market late last year.
But a spate of newer devices, some from the 2 big boys on the block, 1 from fellow medical device giant St. Jude Medical (NYSE:STJ), and some from smaller, less well-known rivals, are in the pipeline.
Earlier this year Boston Scientific took a $129 million pre-tax non-cash impairment of goodwill charge related to the Lotus valve system, which it said could cost more and take longer to bring to market than previously expected.
Company officials said the company took the extra impairment charge because of "revised expectations of the required effort, time and cost involved in completing the in-process projects and bringing the related products to market," according to a regulatory filing.
Boston Scientific CFO Jeffrey Capello said in a conference call with investors in July that the change in expectations was related to the regulatory environment.
"As you look at other people that have come into the U.S. market with clinical programs, clearly, the FDA has been more specific and more expansive in terms of their expectation of clinical programs," he said. "And so we are kind of reading that signal and adjusting our expectations accordingly in terms of our expected spend."