Abbott’s Navitor Device Receives FDA Approval

January 17, 2023—Abbott announced that the FDA has approved the Navitor device, the company’s latest-generation transcatheter aortic valve replacement/implantation (TAVR/TAVI) system, for the treatment of patients with severe aortic stenosis who are at high or extreme risk for open heart surgery.

According to Abbott, Navitor features the NaviSeal fabric cuff to reduce or eliminate paravalvular leak. Additionally, the device is designed with leaflets within the native valve that can help improve access to coronary arteries to facilitate future procedures for treating coronary artery disease. The company stated that the system provides optimal hemodynamics through the valve.

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, noted the company.

Safety information for the device is available on the company’s structural heart website.

Michael Reardon, MD, who is Alison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital in Houston, Texas, served as principal investigator for the study that led to FDA approval.

“Abbott’s Navitor device features advancements to help doctors safely and effectively treat patients with aortic stenosis, including a design that reduces the backflow of blood around the valve that's often a complication following TAVI procedures,” commented Dr. Reardon in the company’s press release. “The innovative Navitor system also offers physicians stable and accurate device placement, even in challenging patient anatomies.”