Abbott has received a CE mark for an expanded indication of its 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.

The company previously received a CE mark in 2021 for Navitor to treat people with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. With the new approval, Navitor is available in Europe for patients across all surgical risk categories.

The expanded indication was supported by positive safety and effectiveness outcomes from the VANTAGE study. It was presented as a late breaked at the European Society of Cardiology (ESC) Congress 2025 and publishing in JACC: Cardiovascular Interventions.

In the first 262 patients with 12-month follow- up completed, there was a 2.3% of all-cause mortality or fatal stroke/stroke with disability. No patients at 30 days had moderate or greater paravalvular leak (PVL) and 13.6% had mild PL, a rate that’s considered low.

“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 Nicolas van Mieghem, M.D., 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.”

There was a 97% rate of technical success with no procedural deaths. “Excellent” hemodynamic performance was also observed 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 Navitor TAVI is approved in the U.S. for patients with symptomatic, severe aortic stenosis at high or extreme risk for open-heart surgery.

Updated transcatheter edge-to-edge repair (TEER) guidelines

During ESC Congress 2025, ESC and the European Association for Cardio-Thoracic Surgery (EACTS) revealed new guidelines to manage valvular heart disease.

Mitral valve TEER was upgraded from a treatment that “should be considered” (IIa) to a “recommended treatment” (Class Ia) for select patients with severe functional (or secondary) mitral regurgitation (MR). Tricuspid valve TER was also upgraded from a treatment that “may be considered” (IIb) to one that “should be considered” (Class IIa) for select patients with severe functional tricuspid regurgitation (TR).

There’s now additional support for use of MitraClip and TriClip for MR and TR patients backed by evidence from multiple clinical studies, including COAPT, TRILUMINATE, TRILUMINATE Pivotal, bRIGHT, RESHAPE-HF2 and TRI.fr, that demonstrate the therapies’ effectiveness.