Abbott Expands Navitor TAVI Approval in Europe to Broader Patient Population
Abbott has received CE Mark in Europe for an expanded indication of its Navitor™ transcatheter aortic valve implantation (TAVI) system. The approval now covers patients with symptomatic, severe aortic stenosis at low or intermediate surgical risk, widening access to a minimally invasive alternative to open-heart surgery. Navitor had previously been cleared in Europe only for those at high or extreme surgical risk.
The decision follows results from the VANTAGE trial, presented as late-breaking data at the European Society of Cardiology (ESC) Congress 2025 and published in JACC: Cardiovascular Interventions. The study showed that Navitor met all safety and effectiveness endpoints, with 12-month results demonstrating low mortality and stroke rates, minimal paravalvular leak, and strong hemodynamic performance. Technical success was reported in 97% of procedures.
Clinicians noted the device’s design may also help preserve treatment options for patients who could require additional cardiac interventions in later years. Aortic stenosis, characterized by narrowing of the aortic valve opening, can lead to heart failure if untreated, and TAVI devices like Navitor are delivered via catheter through a small leg incision.
Alongside the Navitor update, new European guidelines for valvular heart disease management were also presented at ESC. The recommendations strengthened support for transcatheter edge-to-edge repair therapies such as Abbott’s MitraClip™ for severe functional mitral regurgitation and TriClip™ for tricuspid regurgitation, reflecting growing evidence of their clinical benefit.
With this expansion, Navitor becomes available across all surgical risk categories in Europe, while in the U.S. it remains indicated only for patients at high or extreme surgical risk.
