Navitor transcatheter aortic valve implantation (TAVI) system
Navitor TAVI system, Abbott's latest generation TAVI system, has received CE Mark. Patients with severe aortic stenosis and a high or extreme surgical risk can be treated with Navitor.
A paravalvular leak during a valve implant is reduced or eliminated by NaviSeal, a unique fabric cuff in the Navitor system that works with the cardiac cycle. In addition, the access to critical coronary arteries is improved by large frame cells and intra-annular leaflets. Future interventions to treat coronary artery disease can be facilitated by these features found in Navitor, a self-expanding TAVI system.
Abbott's FlexNav delivery system is used for implanting the new TAVI design. Abbott received CE Mark for the FlexNav delivery system in 2020. The treatment of people with small 5mm vessels is enabled by the slim design of the low-profile delivery system. The Navitor system is investigated for its clinical utility in VANTAGE.
Lars Søndergaard, MD. Dr. Søndergaard, Professor of Cardiology at Rigshospitalet, Copenhagen University Hospital in Denmark, and the Co-Principal Investigator for VANTAGE, said that valve implant treatment of patients with complex anatomies with current TAVI systems presents challenges that can be overcome by Navitor.
Only investigational use of Navitor TAVI and FlexNav has been approved. Therefore, they are not yet available for commercial use.
FlexNav delivery system
In 2020, Abbott received a CE mark for its FlexNav delivery system, which, even in complex anatomies, provides improved navigation, flexibility, and delivery of Portico transcatheter aortic valve replacement (TAVR).
It is an interventional trial to assess Navitor TVAI and FlexNav Delivery Systems for the treatment of symptomatic severe aortic stenosis. It is a single group assignment model with an open label. The estimated study start date is June 30, 2021, and the estimated primary completion date is March 31, 2023.