Boston Scientific has received US FDA approval for its Lotus Edge transcatheter aortic valve implantation (TAVI) system. It is approved for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart surgery. Prior to the approval, the only TAVI devices on the US market were Medtronic’s CoreValve and Edwards Lifesciences’ Sapien 3/Sapien XT.
According to a press release, the Lotus Edge valve system is the only FDA-approved aortic valve that gives physicians the option to reposition and completely recapture the valve once it has been fully deployed. The press release notes that the valve also features a braided valve frame and an adaptive seal that minimises paravalvular regurgitation or leaking by conforming to the patient’s native aortic valve.
Ian Meredith, executive vice president and global chief medical officer at Boston Scientific, comments: “We are thrilled to offer physicians in the USA and Europe the clinical benefits of the Lotus Edge valve system for the treatment of their high-risk patients with severe aortic stenosis. This system provides physicians a high level of control over the delivery and deployment of the device and offers surgical-like paravalvular leak results to help ensure the best patient outcomes.”
The FDA approval of the Lotus Edge valve system adds to the Boston Scientific suite of structural heart product solutions—including the Sentinel cerebral protection system and the Watchman left atrial appendage closure device—in the USA. In Europe, the Acurate neo TAVI is also available.
“Bringing the much-anticipated Lotus Edge valve system to market allows us to provide patients who are not good candidates for traditional surgery a safe and effective treatment alternative to restore proper function to their severely narrowed aortic valve. 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,” says Kevin Ballinger, executive vice president and global president, Interventional Cardiology, Boston Scientific.
The company commenced a controlled launch of the valve system in Europe in March and expects to begin a controlled launch in the USA in the coming weeks.