Abbott (NYSE:ABT) announced that it received FDA approval for its latest-generation transcatheter aortic valve implantation (TAVI) system.
The company designed the Navitor system for treating people with severe aortic stenosis at high or extreme risk for open-heart surgery. It adds to Abbott’s transcatheter structural heart portfolio of less invasive treatment options for serious heart diseases.
Abbott entered the U.S. TAVR and TAVI market in 2021 with FDA approval of its Portico with FlexNav system. The company is seeking to compete in a space that Edwards Lifesciences and Medtronic have dominated in the U.S.
Navitor features the NaviSeal unique fabric cuff. This reduces or eliminates the backflow of blood around the valve frame known as paravalvular leak (PVL).
More about Abbott’s Navitor TAVI system
Abbott said in a news release that Navitor is the only self-expanding TAVI system with leaflets within the native valve. This design helps improve access to coronary arteries to facilitate future procedures that treat coronary artery disease.
The system’s design also facilitates blood flow through the valve. Its delivery comes through Abbott’s FlexNav system, which offers a slim design for accommodating different patient anatomies. FlexNav provides stable, predictable and accurate valve delivery and placement.
One-year data presented by Abbott in May supported the Navitor system, too. Navitor demonstrated improved outcomes in patients with severe, symptomatic aortic stenosis who were at high or extreme surgical risk. The system secured a CE mark in 2021.
“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, SVP 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.”
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