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# Boston Scientific Aortic Valve Replacement OK’d
- URL: https://www.fdaweb.com/boston-scientific-aortic-valve-replacement-okd/
- Published: 2019-04-25T12:00:00.000Z
- Updated: 2026-09-15T01:22:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143959

FDA has approved a Boston Scientific PMA for the LOTUS Edge Aortic Valve System. Delivered during a minimally-invasive procedure, the company says the transcatheter aortic valve replacement technology is indicated for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart surgery. LOTUS 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,” it adds. It also features a braided valve frame and an adaptive seal that minimizes leaking by conforming to the patient’s native aortic valve.