Abbott has secured a CE mark for its Navitor transcatheter aortic valve implantation (TAVI) system, expanding its use to individuals with symptomatic, severe aortic stenosis at low or intermediate risk for open-heart surgery.
Previously, the Navitor system was approved in 2021 for patients at high or extreme surgical risk. The latest approval enables the device’s application across all surgical risk categories in Europe, broadening its reach to a larger patient population.
The expanded indication for Navitor is based on positive safety and effectiveness results from the VANTAGE study, which were presented at the European Society of Cardiology (ESC) Congress 2025 in Madrid and published in JACC: Cardiovascular Interventions.
VANTAGE trial principal investigator Nicolas van Mieghem said: “The VANTAGE study provides the scientific backbone for expanding Navitor’s indication to low- and intermediate-risk patients.
“The data are exceptional across both populations, confirming that the Navitor valve performs precisely as designed.
“Up to 50% of younger patients with aortic stenosis will also get coronary artery disease in later years, and Navitor’s design preserves options and ability for lifetime disease management if future cardiac interventions are required.”
Aortic stenosis, characterised by the narrowing of the aortic valve opening, can lead to heart failure and death if untreated.
The Navitor TAVI device offers a minimally invasive solution by replacing the aortic valve through a small incision in the leg, enhancing blood flow, or hemodynamics, through the valve.
The VANTAGE study’s findings, shared at the ESC Congress, confirmed Navitor’s safety and effectiveness for treating patients at low or intermediate surgical risk.
Among the first 262 patients with a 12-month follow-up, there was a low rate of all-cause mortality or disabling stroke at 2.3%.
At 30 days, no patients exhibited a moderate or greater paravalvular leak, with only 13.6% experiencing mild paravalvular leak, considered a low rate.
Additionally, the trial demonstrated a high technical success rate of 97% with no procedural deaths and sustained hemodynamic performance at 12 months.
In the US, the Navitor TAVI system is approved for individuals with symptomatic, severe aortic stenosis at high or extreme risk for open-heart surgery.
Abbott’s structural heart business senior vice president Sandra Lesenfants said: “Navitor is a strong example of how Abbott continues to evolve its structural heart portfolio to meet the growing demand for minimally invasive alternatives to open-heart surgery.
“Aortic stenosis is a life-threatening condition that can progress rapidly, and this expanded indication for Navitor means that patients have more options that can help reduce their symptoms and improve their lives.”
