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# Abbott’s Navitor Approved for Aortic Stenosis
- URL: https://www.fdaweb.com/abbotts-navitor-approved-for-aortic-stenosis/
- Published: 2023-01-17T12:00:00.000Z
- Updated: 2026-09-14T18:11:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153553

FDA has approved Abbott’s latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, for treating people with severe aortic stenosis who are at high or extreme risk for open-heart surgery. Aortic stenosis is the narrowing of the aortic valve’s opening, which restricts blood flow to the body.

The device features the NaviSeal fabric cuff that is intended to reduce or eliminate the backflow of blood around the valve frame known as paravalvular leak. “Additionally,” the company says, “the new device is the only self-expanding TAVI system with leaflets within the native valve; this design can help improve access to coronary arteries to facilitate future procedures for treating coronary artery disease.” The device is implanted using Abbott’s FlexNav delivery system, “which features a slim design to accommodate different patient anatomies and small vessels for stable, predictable and accurate valve delivery and placement,” the company says.