Abbott receives expanded approval for Navitor TAVR system
Abbott has received CE mark approval for its Navitor transcatheter aortic valve replacement (TAVR) system to treat low- and intermediate-risk patients with symptomatic, severe aortic stenosis. The valves originally gained CE mark approval in 2021, but their use was limited to high-risk patients.
“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,” Sandra Lesenfants, senior vice president of Abbott's structural heart business, said in a statement. “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 updated approval came after regulators reviewed new data from the VANTAGE trial presented at ESC 2025, the annual meeting of the European Society of Cardiology, and simultaneously published in JACC: Cardiovascular Interventions.[1] VANTAGE included data from more than 400 patients with a variety of risk profiles who underwent TAVR with the Navitor device from July 2021 to November 2024 in Europe. The technical success rate was 97% and procedural mortality rate was 0%. In addition, 12-month follow-up data linked treatment with low rates of all-cause mortality or stroke and a strong, consistent hemodynamic performance.
“The VANTAGE study provides the scientific backbone for expanding Navitor's indication to low- and intermediate-risk patients,” Nicolas van Mieghem, MD, VANTAGE principal investigator and medical director of the department of interventional cardiology at the Thoraxcenter, Erasmus University Medical Center in the Netherlands, said in the same statement. “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 valve has received U.S. Food and Drug Administration approval for the treatment of high-risk patients. It is not yet approved for low- or intermediate-risk patients.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.