Abbott Receives CE Mark For Expanded Navitor TAVI Indication; Now Approved In Europe For Severe Aortic Stenosis Across All Surgical Risk Categories

Author: Benzinga Newsdesk | August 29, 2025 08:05am

• Navitor is now approved as a minimally invasive alternative to surgery for patients in Europe with symptomatic, severe aortic stenosis (a common and life-threatening heart valve disease) who are at low or intermediate surgical risk
• CE Mark is based on safety and effectiveness data from the VANTAGE trial presented at the European Society of Cardiology (ESC) Congress 2025 and simultaneously published in JACC: Cardiovascular Interventions
• Updated guidelines announced for the management of valvular heart disease provide further support for mitral and tricuspid therapies like MitraClip™ and TriClip™ for leaky heart valves

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.

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