Abbott secures FDA approval for Navitor TAVI device

pharmafile | January 19, 2023 | News story | Medical Communications  

US-based medical device firm Abbott has secured FDA approval for Navitor to treat people with aortic stenosis who are at high or extreme risk for open heart surgery. Transcatheter aortic valve implantation (TAVI) systems like Navitor can be placed with minimally-invasive surgery, reducing complications resulting from age, fragility or other diseases.


Aortic stenosis occurs when the opening of the aortic valve narrows, which in turn limits blood flow to the body; Naviator is a latest-generation TAVI used to combat this. It has a fabric cuff (NaviSeal) to lessen or stop the paravalvular leak (PVL), or the backflow of blood around the valve frame.


Abbott claims that the Navitor is the only self-expanding TAVI system with leaflets within the native valve, which provide very good haemodynamics (blood flow) through the valve.


Abbott’s FlexNav delivery system is used to implant the Navitor device. It has a narrow design and small vessels for stable, predictable and accurate valve delivery and placement.


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 haemodynamics 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.”


James Spargo

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