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ABBOTT PARK, Ill., Aug. 29, 2025 /PRNewswire/ — Abbott (NYSE: ABT) today 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.

“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.”

Aortic stenosis occurs when the aortic valve’s opening narrows, restricting blood flow to the body. Left untreated, it can lead to heart failure and death. The Navitor TAVI device replaces the aortic valve through a minimally invasive procedure and is delivered to the heart through a small incision in the leg. The performance of such devices is measured by blood flow through the valve, referred to as hemodynamics.

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