Navitor is the minimally invasive device designed to treat people with severe aortic stenosis who are at high or extreme surgical risk


Navitor is the latest-generation TAVI system to treat aortic stenosis. (Credit: Abbott)

Healthcare company Abbott has secured CE mark approval for its latest-generation transcatheter aortic valve implantation (TAVI) system called Navitor.

Navitor is the minimally invasive device approved to treat people with severe aortic stenosis who are at high or extreme surgical risk in Europe.

Using the Navitor valve, Abbott is accelerating therapies with innovations including a unique design to prevent blood leaking around the valve.

Abbott has used its FlexNav delivery system to design the Navitor TAVI system. It is part of the firm’s structural heart transcatheter portfolio.

Navitor includes an advanced fabric cuff called NaviSeal, which works with the cardiac cycle to minimise or eliminate a backflow of blood around the valve frame known as paravalvular leak (PVL).

Navitor is claimed to be the only self-expanding TAVI system with intra-annular leaflets and large frame cell.

These features will help enhance access to critical coronary arteries to enable future interventions for the treatment of coronary artery disease (CAD).

Navitor’s new design will also help provide improved haemodynamics or better blood flow.

The device is implanted with the company’s FlexNav delivery system, which secured CE mark approval last year.

It provides a slim design with the lowest TAVI delivery system profile, allowing treating people with vessels as small as 5.0mm.

The slim catheter has the potential to accommodate different aortic anatomies for stable, predictable and accurate valve delivery and placement.

Abbott structural heart business senior vice president Michael Dale said: “The innovative design of the Navitor valve paired with the FlexNav delivery system streamlines and simplifies TAVI procedures for physicians, enabling better valve placement and performance for patients so they can get back to living fuller, healthier lives.

“This approval strengthens our structural heart portfolio of minimally invasive offerings by providing new options and improvements to treat a life-threatening heart condition.”

Last month, Abbott received CE mark approval for its next-generation TriClip transcatheter tricuspid valve repair system.