The US Food and Drug Administration (FDA) has approved Abbott’s latest-generation transcatheter aortic valve implantation (TAVI) system, named Navitor, for the treatment of aortic stenosis.
Navitor has been designed to treat severe aortic stenosis in people who are at high or extreme risk for open-heart surgery.
It comprises a special fabric cuff (NaviSeal) to reduce or eliminate paravalvular leak (PVL), which is the backflow of blood around the valve frame.
Abbott claims that Navitor is the only self-expanding TAVI system with leaflets in the native valve.
This design helps improve access to coronary arteries, enabling future procedures for the treatment of coronary artery disease.
The company’s FlexNav delivery system is used to implant the Navitor device, which provides hemodynamics, or blood flow, through the valve.
The FlexNav delivery system has a slim design, which allows it to accommodate various patient anatomies, and small vessels for stable, predictable and accurate delivery and placement of the valve.
Abbott Structural Heart Business senior vice-president Michael Dale said: “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.
“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.”
The company stated that the Navitor device is the newest addition to its extensive transcatheter structural heart portfolio, which provides physicians and patients with less invasive treatment alternatives for common, serious heart diseases.