Abbott (NYSE: ABT) announced today that it received CE mark for an expanded indication for its Navitor TAVI system.
The expanded indication enables treatment for symptomatic severe aortic stenosis in those at low or intermediate risk for open-heart surgery. Abbott previously received CE mark for the Navitor transcatheter aortic valve implantation (TAVI) system in 2021. That indication covered symptomatic severe aortic stenosis in those at high or extreme surgical risk.
With the new approval, Abbott said it can offer Navitor in Europe for patients across all surgical risk categories. This significantly expands the treatable population for the device. Navitor currently has U.S. approval to treat symptomatic severe aortic stenosis in those at high or extreme risk for open-heart surgery. Abbott launched the latest generation of the valve last year.
At DeviceTalks West Oct. 15-16, 2025, in Santa Clara, California, Abbott Neuromodulation’s Yagna Pathak, PhD, will sit on a panel exploring the clinical applications of connected health. Additionally, Abbott Vascular’s Chief Medical Officer, Dr. Ethan Korngold, will share how AI is shaping Abbott’s cardiovascular portfolio. Learn more and register at West.DeviceTalks.com.
Abbott used outcomes from its VANTAGE study to support the expanded indication. Investigators presented findings at the European Society of Cardiology (ESC) Congress 2025 in Madrid. They also published findings simultaneously in JACC: Cardiovascular Interventions.
The data showed that Navitor met all safety and effectiveness endpoints. In the first 262 patients with 12-month follow-up completed, investigators reported a low (2.3%) rate of all-cause mortality or fatal stroke/stroke with disability. No patients at 30 days had moderate or greater paravalvular leak (PVL) and only 13.6% had mild PVL, registering as a low rate.
Navitor also achieved a high rate of technical success (97%) with no procedural deaths. Investigators reported excellent hemodynamic performance at 12 months as well.
“Navitor is a strong example of how Abbott continues to evolve its structural heart portfolio to meet the growing demand for minimally invasive alternatives to open-heart surgery,” said Sandra Lesenfants, senior vice president of Abbott’s structural heart business. “Aortic stenosis is a life-threatening condition that can progress rapidly, and this expanded indication for Navitor means that patients have more options that can help reduce their symptoms and improve their lives.”
Abbott also reports updated transcatheter edge-to-edge repair (TEER) guidelines
During ESC 2025, ESC and the European Association for Cardio-Thoracic Surgery (EACTS) announced new guidelines for the management of valvular heart disease.
According to Abbott, they upgraded mitral valve TEER from a treatment that should be considered (Class IIa) to a recommended (Class Ia) for selected patients with severe functional (or secondary) mitral regurgitation (MR). They also upgraded tricuspid valve TEER from “may be considered” (IIb) to should be considered (IIa). This applies to patients with severe functional tricuspid regurgitation.
Abbott said the new guidelines provide additional support for the use of its MitraClip and TriClip offerings. It recently launched the latest-generation MitraClip and TriClip G5 versions of the systems.
