Boston Scientific Gets FDA Nod for LOTUS Edge Aortic Valve System
Posted on April 24, 2019 by Medtech[y] Staff
Boston Scientific received FDA approval for their LOTUS Edge Aortic Valve System, which is a transcatheter aortic valve replacement (TAVR) used for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart surgery.
“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,” said Kevin Ballinger, executive vice president and global president, Interventional Cardiology, Boston Scientific. “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 becomes the only FDA approved aortic valve that allows physicians the option to reposition and completely recapture the valve once it is fully deployed.
“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,” said Professor Ian Meredith, AM, executive vice president and global chief medical officer, Boston Scientific. “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.”
The device has been in a controlled launch in Europe since March and Boston Scientific will start their controlled launch in the U.S in the coming weeks.
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