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Abbott Laboratories Receives CE Mark for Expanded Indication for Navitor Aortic Valve Implant
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Abbott Laboratories Receives CE Mark for Expanded Indication for Navitor Aortic Valve Implant
Aug 29, 2025 5:44 AM

08:28 AM EDT, 08/29/2025 (MT Newswires) -- Abbott Laboratories ( ABT ) said Friday that it has received CE Mark in Europe for its Navitor transcatheter aortic valve implantation system to treat patients with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery.

With this expanded indication, Navitor is now available in Europe as a minimally invasive alternative to surgery for patients in all surgical risk categories, the company said.

The device previously received CE Mark in 2021 for treatment of people with severe aortic stenosis who are at high or extreme surgical risk.

The expanded indication was backed by positive safety and effectiveness outcomes from a study, the company said.

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