Boston Scientific’s LOTUS Edge valve system gets FDA approval.

Medical Devices

Boston Scientific’s LOTUS Edge valve system, a minimally invasive transcatheter aortic valve replacement system, is approved for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart surgery. It provides physicians with the option of repositioning and entirely recapturing the valve once it has been fully deployed, and has a braided valve frame and an adaptive seal designed to keep paravalvular regurgitation to a minimum by conforming to the patient's native aortic valve.

Executive vice president and global chief medical officer at Boston Scientific, Professor Ian Meredith, 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."

“Boston Scientific’s LOTUS Edge valve system gets FDA approval.“

Executive vice president and global president, Interventional Cardiology, at Boston Scientific, Kevin Ballinger, 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."

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