FDA Approves Abbott's Next-Gen Navitor TAVI System For Aortic Stenosis

The FDA has approved Abbott Laboratories ABT latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, to treat people with severe aortic stenosis who are at high or extreme risk for open-heart surgery.
The Navitor TAVI system is the latest addition to the company's comprehensive transcatheter structural heart portfolio, offering less invasive treatment options.
Aortic stenosis occurs when the aortic valve's opening narrows, restricting blood flow to the body. Left untreated, it can lead to heart failure and death.
Navitor features a unique fabric cuff (NaviSeal) to reduce or eliminate the backflow of blood around the valve frame, known as a paravalvular leak (PVL).
Additionally, 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 Navitor 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.
Price Action: ABT shares are down 0.04% at $113.47 on the last check Tuesday.