Abbott’s Navitor Gains Expanded CE Mark Approval for Wider Use in Europe

Abbott has received CE Mark approval in Europe for an expanded indication of its Abbott Navitor TAVI system. The device, which treats people with symptomatic, severe aortic stenosis, can now be used in patients at low or intermediate risk for open-heart surgery.

Abbott previously secured CE Mark in 2021 for patients at high or extreme surgical risk. With this new approval, the Navitor TAVI is now available to patients across all surgical risk categories, broadening access to minimally invasive treatment for the condition.

The expanded approval was based on safety and effectiveness data from the VANTAGE trial, presented as a late-breaking study at the European Society of Cardiology (ESC) Congress 2025 in Madrid and published in JACC: Cardiovascular Interventions. Nicolas van Mieghem, M.D., medical director of interventional cardiology at Erasmus University Medical Centre and principal investigator of the VANTAGE trial, highlighted the strength of the data, stating, “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 Abbott Navitor TAVI valve performs precisely as designed.”

Aortic stenosis is a narrowing of the aortic valve opening that restricts blood flow to the body and, if untreated, can lead to heart failure and death. The Navitor device replaces the aortic valve through a minimally invasive procedure delivered via a small incision in the leg.

Results from VANTAGE showed that Abbott Navitor TAVI met all safety and effectiveness endpoints. Among 262 patients with 12-month follow-up, there was a 2.3% rate of all-cause mortality or disabling stroke. No patients experienced moderate or greater paravalvular leak (PVL) at 30 days, and only 13.6% had mild PVL. Technical success was reported at 97%, with no procedural deaths, and sustained hemodynamic performance was maintained at 12 months.

Sandra Lesenfants, senior vice president of Abbott’s structural heart business, noted that the expanded indication allows more patients to benefit from alternatives to open-heart surgery. She emphasized that aortic stenosis is life-threatening and can progress rapidly, with the new approval providing additional treatment options via Abbott Navitor TAVI.

During ESC Congress 2025, new guidelines for managing valvular heart disease were also released. Mitral valve transcatheter edge-to-edge repair (TEER) using MitraClip™ was upgraded to a recommended treatment (Class Ia) for selected patients with severe functional mitral regurgitation. Similarly, tricuspid valve TEER using TriClip™ was elevated to a treatment that should be considered (Class IIa) for selected patients with severe functional tricuspid regurgitation.

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Additional Content Added on Abbott Navitor TAVI

Beyond safety and mortality rates, one of the key advantages of Abbott Navitor TAVI lies in its design features that help reduce complications and preserve future treatment flexibility. Its self-expanding frame and intra-annular leaflets allow large frame cells which may facilitate access to coronary arteries in subsequent interventions. The fabric cuff helps to reduce paravalvular leak, which has been a notable issue in some earlier TAVI designs. Cardiovascular News+1

Patient selection remains critical. The new ESC/EACTS guidelines reaffirm that decisions between TAVI and surgical aortic valve replacement should consider age, valve anatomy (e.g. tricuspid vs bicuspid valves), patient preference, comorbidities, and lifetime management. For older patients (≥70 years) with tricuspid aortic stenosis and favorable anatomy, TAVI (including abbott navitor tavi) is now more strongly considered, even if their surgical risk is low. European Society of Cardiology+2Cardiovascular News+2

Long-term follow-up remains important. While the VANTAGE trial provides up to one year outcomes, durability of the valve, outcomes past one year, incidence of structural valve deterioration, reintervention needs, and quality of life over time will determine how widely Abbott Navitor TAVI becomes adopted in younger populations. Clinical centers will need to ensure robust monitoring and imaging to detect any issues early.