Abbott’s Navitor TAVI Expansion Drives $590M Surge as European Approval Broadens Market Reach

Abbott (ABT) edged up 0.98% on August 29, with a trading volume of $0.59 billion. The stock’s performance coincided with regulatory and clinical developments for its Navitor transcatheter aortic valve implantation (TAVI) system. Abbott announced the expansion of the Navitor TAVI system’s CE Mark in Europe, now allowing treatment for patients with symptomatic, severe aortic stenosis across all surgical risk categories—low, intermediate, high, or extreme. This marks a significant expansion from its 2021 approval, which was limited to high-risk patients.

The approval was supported by the VANTAGE trial data presented at the European Society of Cardiology (ESC) Congress 2025. Key findings highlighted a 2.3% rate of all-cause mortality or disabling stroke at 12 months, no moderate or severe paravalvular leak at 30 days, and a 97% technical success rate. These outcomes underscore the device’s safety and efficacy, particularly for lower-risk patients. Abbott’s structural heart business emphasized that Navitor’s design preserves future options for coronary interventions, addressing long-term disease management concerns.

Complementing this, updated ESC guidelines elevated the recommendation status for Abbott’s MitraClip and TriClip therapies for mitral and tricuspid regurgitation. Mitral valve transcatheter edge-to-edge repair (TEER) was upgraded to Class Ia, while tricuspid TEER moved to Class IIa. These changes reinforce the clinical value of Abbott’s structural heart portfolio, aligning with growing demand for minimally invasive treatments.

The VANTAGE trial results demonstrated sustained hemodynamic performance at 12 months, with no procedural deaths and low rates of adverse events. These findings, coupled with the expanded CE Mark, position Abbott to broaden its European market reach. The U.S. approval for Navitor remains restricted to high-risk patients, but the European expansion could inform future regulatory submissions in other regions.