US-based medical device and healthcare company Abbott (NYSE:ABT) announced on Friday that it has received CE Mark in Europe for an expanded indication for its 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.

The company says that the expanded indication was supported by favourable safety and effectiveness outcomes from the VANTAGE study, which was presented as a late breaker at the European Society of Cardiology (ESC) Congress 2025, held in Madrid (29 August-1 September 2025). These data were simultaneously published in JACC: Cardiovascular Interventions.

Abbott's Navitor TAVI device replaces the aortic valve through a minimally invasive procedure and is delivered to the heart through a small incision in the leg. The performance of such devices is measured by blood flow through the valve, referred to as haemodynamics.

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