Abbott's Navitor™ TAVI System Receives CE Mark for Expanded Indication to Treat More People With Aortic Stenosis

Rhea-AI Summary

Abbott (NYSE:ABT) has received CE Mark approval for an expanded indication of its Navitor™ TAVI system to treat patients with symptomatic, severe aortic stenosis who are at low or intermediate surgical risk. This expansion, supported by the VANTAGE trial data, makes Navitor available across all surgical risk categories in Europe.

The VANTAGE study demonstrated excellent outcomes, including a low 2.3% rate of all-cause mortality or fatal stroke/stroke with disability, no moderate or greater PVL at 30 days, and a 97% technical success rate. Additionally, the European Society of Cardiology announced updated guidelines upgrading recommendations for Abbott's MitraClip™ and TriClip™ therapies for treating heart valve diseases.

Positive

• Expanded CE Mark approval significantly increases addressable patient population in Europe
• Strong VANTAGE trial results with 97% technical success rate and no moderate/severe PVL at 30 days
• Low 2.3% rate of all-cause mortality or fatal stroke/stroke with disability
• Upgraded treatment recommendations for MitraClip and TriClip in European guidelines

Negative

• None.

Insights

Medical Device Market Analyst

Abbott's Navitor TAVI system receives expanded CE Mark, significantly increasing its addressable market across all surgical risk categories in Europe.

Abbott has secured a major regulatory win with the CE Mark expansion for its Navitor transcatheter aortic valve implantation (TAVI) system in Europe. This approval extends Navitor's use to patients with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery—a significant expansion from its previous 2021 approval for only high or extreme risk patients.

The expanded indication is supported by the VANTAGE trial data, which demonstrated exceptional safety outcomes with just 2.3% rate of all-cause mortality or disabling stroke at 12 months. Equally impressive was the absence of moderate or greater paravalvular leak (PVL) at 30 days, with only 13.6% of patients showing mild PVL—considerably lower than rates typically seen with TAVI devices.

This approval substantially increases Abbott's addressable market in Europe, as the company can now offer Navitor across all surgical risk categories. The competitive landscape for TAVI devices in Europe has primarily been dominated by Edwards Lifesciences and Medtronic, but Abbott's expanded indication puts them in a stronger position to gain market share.

Notably, the approval comes alongside updated European guidelines that elevate transcatheter edge-to-edge repair (TEER) treatments, including Abbott's MitraClip and TriClip, to higher recommendation levels for treating mitral and tricuspid regurgitation. This represents a double regulatory victory for Abbott's structural heart portfolio and strengthens their position in the rapidly growing transcatheter valve therapy market.

While the U.S. indication for Navitor remains limited to high or extreme risk patients, this European expansion provides Abbott with valuable real-world evidence that could support future FDA applications for similar indication expansions in the American market.

Cardiovascular Specialist

Abbott's Navitor TAVI shows exceptional clinical performance in low/intermediate risk patients, representing a significant advancement in aortic stenosis treatment.

The expanded CE Mark for Abbott's Navitor TAVI system represents a significant clinical advancement in the treatment of aortic stenosis. The VANTAGE trial results demonstrate remarkably strong performance metrics that address key concerns traditionally associated with transcatheter valves.

Most notably, Navitor achieved zero moderate-to-severe paravalvular leak (PVL) at 30 days—an exceptional outcome compared to historical TAVI data. PVL has been consistently associated with worse long-term outcomes, including increased mortality. The 13.6% mild PVL rate is also impressively low, suggesting superior valve design and deployment accuracy.

The 2.3% rate of all-cause mortality or disabling stroke at 12 months is compelling evidence of Navitor's safety profile. This compares favorably to surgical outcomes in similar risk populations and addresses one of the historical concerns about expanding TAVI to younger, lower-risk patients.

Dr. van Mieghem's comment about preserving future options for coronary intervention highlights a crucial but often overlooked clinical consideration. As TAVI expands to younger patients, the valve design must accommodate potential future coronary artery disease treatment. Navitor's design apparently preserves coronary access, which is vital for lifetime disease management.

The sustained hemodynamic performance at 12 months suggests durable valve function—another critical factor when considering TAVI for lower-risk, typically younger patients with longer life expectancy. The 97% technical success rate with zero procedural deaths further underscores the system's reliability and safety.

These results position Navitor as a strong contender in the expanding TAVI market and provide compelling clinical evidence supporting the use of transcatheter approaches across all risk categories for aortic stenosis patients.

• Navitor is now approved as a minimally invasive alternative to surgery for patients in Europe with symptomatic, severe aortic stenosis (a common and life-threatening heart valve disease) who are at low or intermediate surgical risk
• CE Mark is based on safety and effectiveness data from the VANTAGE trial presented at the European Society of Cardiology (ESC) Congress 2025 and simultaneously published in JACC: Cardiovascular Interventions
• Updated guidelines announced for the management of valvular heart disease provide further support for mitral and tricuspid therapies like MitraClip™ and TriClip™ for leaky heart valves

ABBOTT PARK, Ill., Aug. 29, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it has received CE Mark in Europe for an expanded indication for the company's Navitor™ transcatheter aortic valve implantation (TAVI) system to treat people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery. Abbott previously received CE Mark in 2021 for Navitor to treat people with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. With this new approval, Navitor is available in Europe for patients across all surgical risk categories, significantly expanding the number of people that can be treated with the device.

The expanded indication was supported by favorable safety and effectiveness outcomes from the VANTAGE study, which was presented as a late breaker at the European Society of Cardiology (ESC) Congress 2025, held in Madrid (Aug. 29-Sept. 1, 2025). These data were simultaneously published in JACC: Cardiovascular Interventions. 

"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," said Nicolas van Mieghem, M.D., medical director of the department of interventional cardiology at the Thoraxcenter, Erasmus University Medical Centre, in the Netherlands, who serves as principal investigator of the VANTAGE trial. "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 occurs when the aortic valve's opening narrows, restricting blood flow to the body. Left untreated, it can lead to heart failure and death. The Navitor TAVI device replaces the aortic valve through a minimally invasive procedure and is delivered to the heart through a small incision in the leg. The performance of such devices is measured by blood flow through the valve, referred to as hemodynamics.

Key findings from the VANTAGE trial
The late-breaking data presented at ESC from Abbott's VANTAGE study showed Navitor met all safety and effectiveness primary endpoints, supporting its expansion to treat people with symptomatic, severe aortic stenosis who are at low or intermediate surgical risk. Key findings include:

• Excellent safety. In the first 262 patients with 12-month follow-up completed, there was a low rate (2.3%) of all-cause mortality or fatal stroke/stroke with disability.
• Proven effectiveness. No patients at 30 days had moderate or greater PVL (paravalvular leak or backflow of blood around the valve) and only 13.6% had mild PVL, a rate that is considered low.^1,2,3,4
• High technical success: There was a high rate of technical success (97%) with no procedural deaths.
• Sustained hemodynamic performance. Excellent hemodynamic performance was seen at 12 months.

"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," said Sandra Lesenfants, senior vice president of Abbott's structural heart business. "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."

The Navitor TAVI system is currently approved in the U.S. to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.

Updated transcatheter edge-to-edge repair (TEER) guidelines
During ESC Congress 2025, ESC and the European Association for Cardio-Thoracic Surgery (EACTS) announced new guidelines for the management of valvular heart disease. Mitral valve TEER was upgraded from a treatment that should be considered (IIa) to a recommended treatment (Class Ia) for selected patients with severe functional (or secondary) mitral regurgitation (MR). Tricuspid valve TEER was also upgraded from a treatment that may be considered (IIb) to a treatment that should be considered (Class IIa) for selected patients with severe functional tricuspid regurgitation (TR). 

With these updated guidelines, there's additional support for the use of MitraClip™ and TriClip™ for MR and TR patients that is backed by evidence from multiple clinical studies, including COAPT, TRILUMINATE, TRILUMINATE Pivotal, bRIGHT, RESHAPE-HF2 and TRI.fr, that demonstrate the therapies' effectiveness.

For U.S. important safety information about MitraClip and TriClip, visit https://abbo.tt/TEERG5ISI.

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.  

¹ Thourani VH, Kodali S, Makkar RR, Herrmann HC, Williams M, Babaliaros V, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet 2016;387(10034):2218–2225; doi: 10.1016/S0140-6736(16)30073-3.
² Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med 2019;380(18):1706–1715; doi: 10.1056/NEJMoa1816885.
³ Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med 2019;380(18):1695–1705; doi: 10.1056/NEJMoa1814052.
⁴ Makkar RR, Ramana RK, Gnall E, et al. ACURATE neo2 valve versus commercially available transcatheter heart valves in patients with severe aortic stenosis (ACURATE IDE): a multicentre, randomised, controlled, non-inferiority trial. The Lancet. 2025;405:2061–2074.

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SOURCE Abbott

FAQ

What is the new CE Mark approval for Abbott's Navitor TAVI system in 2025?

Abbott's Navitor TAVI system received CE Mark approval for treating patients with symptomatic, severe aortic stenosis who are at low or intermediate surgical risk, expanding its previous indication that only covered high or extreme risk patients.

What were the key results from Abbott's VANTAGE trial for Navitor?

The VANTAGE trial showed 97% technical success, a low 2.3% rate of all-cause mortality or fatal stroke/stroke with disability, and no moderate or greater PVL at 30 days, with only 13.6% mild PVL.

How does Abbott's Navitor TAVI system treat aortic stenosis?

Navitor TAVI is a minimally invasive procedure that replaces the aortic valve through a small incision in the leg, treating aortic stenosis without requiring open-heart surgery.

What is the current approval status of Abbott's Navitor TAVI system in the United States?

In the United States, Navitor TAVI is currently approved only for treating people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.

How did the ESC guidelines change for Abbott's MitraClip and TriClip in 2025?

MitraClip was upgraded to a recommended treatment (Class Ia) for selected patients with severe functional mitral regurgitation, while TriClip was upgraded to a treatment that should be considered (Class IIa) for selected patients with severe functional tricuspid regurgitation.