Abbott’s Navitor TAVI System Receives CE Mark

May 17, 2021—Abbott announced its Navitor transcatheter aortic valve implantation (TAVI) system has received CE Mark. Navitor, the company’s latest generation TAVI system, is designed to treat patients with severe aortic stenosis at high or extreme surgical risk.

The Navitor system utilizes NaviSeal, a unique fabric cuff that works with the cardiac cycle to reduce or eliminate paravalvular leak, noted the company. According to Abbott, Navitor is the only self-expanding TAVI system with intra-annular (within the native valve) leaflets and large frame cells. These features are designed to help improve access to critical coronary arteries to facilitate future interventions to treat coronary artery disease.

The new TAVI system is implanted using Abbott’s FlexNav delivery system, which itself received CE Mark in 2020. The slim design of the low-profile delivery system enables the treatment of people with vessels as small as 5 mm.

 “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,” said Lars Søndergaard, MD. Dr. Søndergaard is Professor of Cardiology at Rigshospitalet, Copenhagen University Hospital in Denmark, and served as Co-Principal Investigator for VANTAGE, the global Navitor TAVI system clinical study.

The Navitor transcatheter aortic valve and FlexNav delivery system are not available for commercial use in the United States and are only approved for investigational use.