Marlborough, Mass.-based Boston Scientific touted the device as the only TAVR on the U.S. market designed to be repositioned or recaptured after deployment. The path to PMA wasn’t an entirely smooth one; in October 2016 the company paused Lotus Edge implantations in Europe to investigate a locking mechanism issue, which it had resolved by January 2017. The final PMA application module went to the federal safety watchdog last August.
“Bringing the much-anticipated Lotus Edge valve system to market allows us to provide patients who aren’t good candidates for traditional surgery a safe and effective treatment alternative to restore proper function to their severely narrowed aortic valve,” interventional cardiology president Kevin Ballinger said in prepared remarks. “This technology is a fundamental component of our expanding portfolio and demonstrates our continuing commitment to category leadership within the fast-growing structural heart treatment landscape.”
“We are thrilled to offer physicians in the U.S. and Europe the clinical benefits of the Lotus Edge valve system for the treatment of their high-risk patients with severe aortic stenosis,” added global CMO Dr. Ian Meredith. “This system provides physicians a high level of control over the delivery and deployment of the device and offers surgical-like PVL results to help ensure the best patient outcomes.”
Boston said it began a controlled launch of the valve in Europe last month and plans to initiate a similar debut here “in the coming weeks.”