Abbott's Navitor TAVI System Receives CE Mark for Expanded Aortic Stenosis Indication

Analysis reveals significant industry trends and economic implications

Release Date

2025-09-01

Category

Drug Approval Event

Reference

Source

Breakthrough Clinical Results

Abbott announced that its Navitor transcatheter aortic valve implantation (TAVI) system received CE Mark approval in Europe for an expanded indication. The approval now allows Navitor to treat patients with symptomatic, severe aortic stenosis across all surgical risk categories (low, intermediate, high, and extreme), significantly increasing the number of treatable patients. This expansion is based on positive safety and effectiveness data from the VANTAGE trial, presented at the European Society of Cardiology (ESC) Congress 2025 and published in JACC: Cardiovascular Interventions. The trial demonstrated excellent safety and effectiveness, including a low rate of mortality and stroke, minimal paravalvular leak, and high technical success. Abbott also highlighted updated ESC and EACTS guidelines supporting the use of MitraClip™ and TriClip™ for mitral and tricuspid valve regurgitation.

Key Highlights

  • CE Mark approval for Navitor TAVI system expanded to include low and intermediate surgical risk patients with symptomatic, severe aortic stenosis.
  • Positive safety and effectiveness data from the VANTAGE trial supported the expanded indication.
  • Navitor is now available in Europe for patients across all surgical risk categories.
  • Updated guidelines support the use of MitraClip™ and TriClip™ for mitral and tricuspid valve regurgitation.

Incidence and Prevalence

Global Incidence and Prevalence of Aortic Stenosis

The incidence of aortic stenosis (AS) is predicted to rise with the aging population, emerging as a growing public health challenge in developed countries, leading to an increased demand for intervention.

Research analyzing data from 2001-2021 demonstrates significant demographic shifts that contribute to this trend. There was an increase in the overall population, particularly among the elderly with a 1.4% growth rate in the population ≥ 65 years old. The aging index increased substantially from 128.4 (110.5-180.6) in 2001 to 189.1 (155.9-222.5) in 2021 (p-value < 0.001). Similarly, the longevity index significantly increased between 2001 [42.6 (40.8-44.80)] and 2021 [49.30 (47.7-51.8)] (p-value < 0.001).

In a study of 47,436 patients admitted with acute myocardial infarction (AMI), pre-existing valvular heart disease (VHD) was diagnosed in 1,445 patients (3.0%). Among those with pre-existing VHD, moderate-to-severe aortic stenosis was found in 869 patients (60.1%).

Patients with VHD demonstrated worse baseline characteristics, pre-existing coronary artery disease, more complicated in-hospital course with higher Killip class, lower left ventricular ejection fraction, and more comorbidities. These patients had significantly higher mortality rates at multiple time points compared to patients without VHD: 7-day (10.1% vs. 4.5%, p < 0.001), 30-day (16.0% vs. 7.0%, p < 0.001) and 1-year mortality (28.7 vs. 12.7%, p < 0.001).

Additionally, aortic valve calcification (AVC) was identified as an independent predictor of poor prognosis in elderly patients with severe COVID-19 [odds ratio (OR) =4.915, 95% confidence interval (CI): 1.266-19.085, P=0.02].

These findings highlight the significant impact of aortic stenosis on patient outcomes and underscore the importance of addressing this condition as populations continue to age worldwide.

Recent Studies

Recent Studies for Aortic Stenosis

Optimize PRO Study

Optimize PRO is a multicenter, postmarket, prospective study conducted across 50 centers in the United States, Canada, Europe, the Middle East, and Australia. This study evaluated transcatheter aortic valve replacement (TAVR) using Evolut PRO/PRO+ valves with an optimized care pathway and the cusp overlap technique (COT).

Key Outcomes:

  • Safety: The primary 30-day endpoint of all-cause mortality or all stroke was 5.1%, with all-cause mortality at 0.8% and disabling stroke at 1.7%
  • Pacemaker Implantation: New 30-day permanent pacemaker implantation rate was 6.4% with 4-step COT compliance and 11.1% overall
  • Valve Performance: At discharge, no instances of moderate or severe aortic regurgitation were observed, with 76.2% of patients having none/trace aortic regurgitation
  • Hospital Stay: Median length of stay was 2 days

Balloon-Expandable vs Self-Expanding Valves Study

A single-center study compared outcomes between balloon-expandable (BE) valves (S3, Ultra) and self-expanding (SE) valves (Evolut R, PRO, PRO+) in patients undergoing transfemoral TAVR.

Key Outcomes:

  • Safety: Similar in-hospital mortality (0.9% vs 0.6%), stroke (1.3% vs 1.8%), major vascular complications (2.8% vs 2.2%) and composite bleeding (4.7% vs 3.4%)
  • Pacemaker Need: BE cohort required fewer permanent pacemakers (8.3% vs 13.3%, p=0.003)
  • Long-term Outcomes: At 1-year, similar all-cause mortality (10.8% vs 11.2%), hospital readmission (22.5% vs 19.6%), and KCCQ12 scores (83.7±25.5 vs 83.0±24.6)
  • Extended Follow-up: At median follow-up of 77.0 months, no significant difference in all-cause mortality (33.2% vs 40.4%)
  • Complications: BE patients more commonly required treatment for subclinical leaflet thrombosis, while SE patients had a higher incidence of transient ischemic attack

TAVI vs SAVR Meta-Analysis

A meta-analysis compared transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for prosthetic valve endocarditis (PVE).

Key Outcomes:

  • 30-day Mortality: No significant difference in 30-day mortality of PVE between TAVI and SAVR (OR 1.29, CI 0.98-1.69)
  • PVE Incidence: Significant difference in PVE incidence (HR 0.76, CI 0.61-0.96), with TAVI demonstrating a protective effect
  • Benefit Mechanism: TAVI's protective effect attributed to its lesser invasiveness and shorter procedural times

Drug used in other indications

Navitor Clinical Trials Beyond Aortic Stenosis

Based on a comprehensive review of available information, there is insufficient data to determine if the Navitor transcatheter heart valve is currently being trialed for indications other than aortic stenosis.

The only relevant information found indicates that "Portico/Navitor-family devices" have been mentioned in the context of TAVR (Transcatheter Aortic Valve Replacement) for bicuspid aortic valve stenosis, which is still within the broader category of aortic stenosis treatment.

There is no specific information available regarding:

  • Clinical trials investigating Navitor for non-aortic stenosis indications
  • Phase II or Phase III trials exploring alternative uses
  • Intervention models for such trials
  • Primary or secondary endpoints for novel applications
  • Specific procedural techniques for non-aortic stenosis applications

The Navitor device appears to be primarily focused on its approved indication for treating severe calcific aortic stenosis through transcatheter aortic valve replacement procedures.

Without additional clinical trial registry data or published research protocols, it is not possible to definitively state whether Navitor is being investigated for expanded indications beyond various forms of aortic stenosis.

Healthcare professionals interested in the latest applications of the Navitor system should consult the manufacturer's clinical development pipeline or search clinical trial registries for the most current information on ongoing or planned studies.