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

The FDA has approved Abbott Laboratories (NYSE:ABT) latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, to treat people with severe…
  • The FDA has approved Abbott Laboratories (NYSE: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.
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