Abbott Labs has gained U.S. Food and Drug Administration (FDA) approval for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, to treat patients with severe aortic stenosis at high or extreme risk for open-heart surgery.
 
The Navitor TAVI system is the latest in the company’s transcatheter structural heart portfolio, which offers less invasive treatment options for some of the most common and serious heart conditions.
 
“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,” Michael Reardon, MD, Alison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital, who served as principal investigator for the study that led to FDA approval, told the press. “The innovative Navitor system also offers physicians stable and accurate device placement, even in challenging patient anatomies.”
 
Navitor’s NaviSeal fabric cuff aims to reduce backflow of blood around the valve frame (paravalvular leak—PVL). According to Abbott, Navitor is the only self-expanding TAVI system with leaflets in the native valve, which can help improve access to coronary arteries and facilitate future procedures to treat coronary artery disease.
 
Navitor is implanted through Abbott’s FlexNav delivery, which touts a slim design to accommodate different patient anatomies and small vessels.
 
“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 VP of 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.”