Abbott (NYSE:ABT) announced that it has obtained the CE Mark in Europe for a broader use of its Navitor transcatheter aortic valve implantation system.
This new approval allows the treatment of patients suffering from symptomatic, severe aortic stenosis who are considered to be at low or intermediate risk for open-heart surgery.
Previously, in 2021, Abbott received the CE Mark for Navitor to treat individuals with symptomatic, severe aortic stenosis who faced high or extreme surgical risks.
The decision for this expanded indication was based on positive safety and effectiveness results from the VANTAGE study.
