Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for the LOTUS Edge Aortic Valve System.
Delivered via a minimally-invasive procedure, this transcatheter aortic valve replacement (TAVR) technology is approved for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart surgery.
Kevin Ballinger, executive vice president and global president, Interventional Cardiology, Boston Scientific, said: "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. 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."
The LOTUS Edge valve system gives physicians the option to reposition and completely recapture the valve once it has been fully deployed. It also features a braided valve frame and an adaptive seal aimed to minimise paravalvular regurgitation or leaking (PVL) by conforming to the patient's native aortic valve.
Professor Ian Meredith, executive vice president and global chief medical officer, Boston Scientific said: "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. 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."
