TAVI: Boston Scientific enrolls 1st patient in Reprise II Lotus valve study
Medical device giant Boston Scientific launches a new study of its Lotus transcatheter aortic valve implantation system, enrolling the 1st patient in a 120-member trial expected to lead to CE Mark approval in the European Union in the 1st half of 2013.
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.