Abbott’s Navitor TAVR System Approved in Europe for Low- and Intermediate-Risk Patients

August 29, 2025—Abbott announced it has received European CE Mark approval for an expanded indication for the company’s Navitor transcatheter aortic valve replacement (TAVR) system to treat patients with symptomatic, severe aortic stenosis who are at low or intermediate risk for open heart surgery.

The company stated that Navitor is now available in Europe for patients across all surgical risk categories. In 2021, Abbott announced that Navitor received CE Mark approval to treat patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk.

According to the company, the expanded indication was supported by favorable safety and effectiveness outcomes from the VANTAGE study. The VANTAGE findings were presented at the 2025 European Society of Cardiology Congress. The VANTAGE data were simultaneously published by Stephen G. Worthley, MBBS, et al in JACC: Cardiovascular Interventions.

As outlined in the company’s press release, key findings from VANTAGE include the following:

• 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.
• Effectiveness: No patients at 30 days had moderate or greater paravalvular leak (PVL). Only 13.6% had mild PVL.
• 97% rate of technical success with no procedural deaths.
• Excellent hemodynamic performance at 12 months.

The Principal Investigator of the VANTAGE trial is Nicolas van Mieghem, MD, Medical Director of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus University Medical Center, in Rotterdam, the Netherlands.

“The VANTAGE study provides the scientific backbone for expanding Navitor’s indication to low- and intermediate-risk patients,” commented Dr. van Mieghem in Abbott’s press release. “The data are exceptional across both populations, confirming that the Navitor valve performs precisely as designed.

“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.”

In the United States, the Navitor TAVR system is currently approved to treat patients with symptomatic, severe aortic stenosis who are at high or extreme risk for open heart surgery, advised the company. Abbott announced FDA approval in January 2023.