Abbott has received the CE Mark approval for Navitor, its new-generation transcatheter aortic valve implantation (TAVI) system, for treating severe aortic stenosis in Europe.

The minimally invasive device is indicated for people with severe aortic stenosis, who are at high or extreme surgical risk.

Navitor valve advances TAVI therapies including a unique design to prevent blood leaking around the valve, said the US-based health care company.

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.”

Aortic stenosis restricts blood flow through the aortic heart valve to the rest of the body, which can lead to heart failure and sudden cardiac death in certain cases.

TAVI systems offer a less invasive alternative to surgical aortic valve replacement, reducing symptoms and improving the lives of patients with the debilitating condition.

Navitor TAVI system is implanted using Abbott’s advanced FlexNav delivery system, to provide physicians and patients with less invasive options to treat heart diseases.

FlexNav delivery system was granted CE Mark in 2020, for the treatment of people with vessels as small as 5mm.

The Navitor system features a unique fabric cuff (NaviSeal) that works with the cardiac cycle to prevent the backflow of blood around the valve frame, dubbed paravalvular leak (PVL).

PVL is a common complication following TAVI procedures.

Abbott said that the new Navitor device is the only self-expanding TAVI system with intra-annular leaflets and large frame cells, and it provides improved haemodynamics.

Also, its features are designed to improve access to critical coronary arteries to facilitate future interventions to treat coronary artery disease (CAD).

Global Navitor TAVI system clinical study co-principal investigator Lars Søndergaard said: “With an ageing world population and with aortic stenosis cases projected to double in Europe and the U.S. in the next few decades, the need for innovative, minimally invasive solutions is critical.

“While transcatheter valve replacement has for some time been a standard of care for patients with a narrowing of the aortic valve, Navitor helps to address challenges we sometimes find in current TAVI systems when we encounter complex patient anatomies that can lead to potential complications.”