Abbott Gets CE Mark For Expanded Indication For Navitor TAVI System

(RTTNews) - Abbott (ABT) has received CE Mark in Europe for an expanded indication for the Navitor transcatheter aortic valve implantation system to treat people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery. The expanded indication was supported by favorable safety and effectiveness outcomes from the VANTAGE study.

Abbott received 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 Navitor TAVI system is currently approved in the U.S. to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.

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