FDA Approves Next-Generation TAVI System for Aortic Stenosis Treatment

US Food and Drug Administration (FDA)

The US Food and Drug Administration (FDA) has approved the transcatheter aortic valve implantation (TAVI) system Navitor™ from Abbott to treat patients with severe aortic stenosis at high or extreme risk for open heart surgery.

The next-generation system is a minimally invasive alternative to open-heart surgery for people with aortic stenosis. It is the latest addition to the company’s structural heart portfolio that offers less invasive treatment options to physicians and patients with common and serious heart diseases.

"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," said Michael Reardon, MD, Alison Family Distinguished Chair of Cardiovascular Research, Houston Methodist Hospital, in the release. "The innovative Navitor system also offers physicians stable and accurate device placement, even in challenging patient anatomies."

The device features a unique fabric cuff (NaviSeal™) to reduce or eliminate the backflow of blood around the valve frame known as paravalvular leak (LV). The company noted the new system is the only self-expanding TAVI system with leaflets within the native valve. This may help improve access to coronary arteries to facilitate future procedures for treatment of coronary artery disease, if needed.

The system provided excellent hemodynamics through the valve, according to the company. The device is implanted using the company’s FlexNav™ delivery system, which can accommodate different patient anatomies for accurate valve delivery and placement.

"Our Navitor valve builds upon our industry-leading portfolio of minimally invasive devices that surpass existing standards of care to address a range of heart diseases," said Michael Dale, senior vice president, Abbott's structural heart business. "Navitor is the first TAVI system to offer optimal hemodynamics in all valve sizes while also preserving options for lifetime disease management, an important consideration for physicians and patients when selecting a TAVI solution. Receiving this approval is a major next step in our mission to help people live better lives through better health."