Navitor TAVI system receives CE Mark for expanded indication to treat more people with aortic stenosis – Abbott

Abbott announced it has received CE Mark in Europe for an expanded indication for the company’s Navitor transcatheter aortic valve implantation (TAVI) system to treat people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery. Abbott previously received CE Mark in 2021 for Navitor to treat people with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. With this new approval, Navitor is available in Europe for patients across all surgical risk categories, significantly expanding the number of people that can be treated with the device.

The expanded indication was supported by favorable safety and effectiveness outcomes from the VANTAGE study, which was presented as a late breaker at the European Society of Cardiology (ESC) Congress 2025, held in Madrid (Aug. 29-Sept. 1, 2025). These data were simultaneously published in JACC: Cardiovascular Interventions.

Key findings from the VANTAGE trial
The late-breaking data presented at ESC from Abbott’s VANTAGE study showed Navitor met all safety and effectiveness primary endpoints, supporting its expansion to treat people with symptomatic, severe aortic stenosis who are at low or intermediate surgical risk. Key findings include:

• Excellent safety. In the first 262 patients with 12-month follow-up completed, there was a low rate (2.3%) of all-cause mortality or fatal stroke/stroke with disability.
• Proven effectiveness. No patients at 30 days had moderate or greater PVL (paravalvular leak or backflow of blood around the valve) and only 13.6% had mild PVL, a rate that is considered low.
• High technical success: There was a high rate of technical success (97%) with no procedural deaths.
• Sustained hemodynamic performance. Excellent hemodynamic performance was seen at 12 months.

“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.”

“The VANTAGE study provides the scientific backbone for expanding Navitor’s indication to low- and intermediate-risk patients. The data are exceptional across both populations, confirming that the Navitor valve performs precisely as designed,” said Dr. Nicolas van Mieghem, medical director of the department of interventional cardiology at the Thoraxcenter, Erasmus University Medical Centre, in the Netherlands, who serves as principal investigator of the VANTAGE trial. “Up to 50% of younger patients with aortic stenosis will also get coronary artery disease in later years, and Navitor’s design preserves options and ability for lifetime disease management if future cardiac interventions are required.”

See citation- Worthley S, Giordano A, Corcione N. et al. Thirty-Day And One-Year Outcomes Of Navitor Transcatheter Aortic Valve In Low- or Intermediate-Risk Patients. J Am Coll Cardiol Intv. null2025, 0 (0) . https://doi.org/10.1016/j.jcin.2025.08.021