Abbott (NYSE:ABT) announced today that it received CE mark approval for its Navitor transcatheter aortic valve implantation (TAVI) system.
The latest-generation TAVI system from Abbott, Navitor won European approval for treating those with severe aortic stenosis who are at high or extreme surgical risk, according to a news release.
Navitor uses Abbott’s FlexNav delivery system along with a unique design for preventing blood leaking around the valve to provide a less invasive alternative to surgical aortic valve replacement. It features the NaviSeal fabric cuff that works as with the cardiac cycle to reduce or eliminate the backflow of blood around the valve (a paravalvular leak), too.
Abbott Park, Ill.-based Abbott touts Navitor as the only self-expanding TAVI system with intra-annular leaflets and large frame cells designed to improve access to critical coronary arteries and facilitate future interventions to treat coronary artery disease.
“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,” SVP of Abbott’s structural heart business Michael Dale said in the release. “This approval strengthens our structural heart portfolio of minimally invasive offerings by providing new options and improvements to treat a life-threatening heart condition.”
The Navitor transcatheter aortic valve and FlexNav delivery system only have investigational use approval in the U.S.
