Abbott's Navitor鈩� TAVI System Receives CE Mark for Expanded Indication to Treat More People With Aortic Stenosis
Abbott (NYSE:ABT) has received CE Mark approval for an expanded indication of its Navitor鈩� 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 惭颈迟谤补颁濒颈辫鈩� and 罢谤颈颁濒颈辫鈩� therapies for treating heart valve diseases.
Abbott (NYSE:ABT) ha ottenuto l'approvazione CE per un'indicazione ampliata del suo sistema TAVI Navitor鈩� per il trattamento di pazienti con stenosi aortica severa sintomatica a basso o medio rischio chirurgico. Questa estensione, supportata dai dati dello studio VANTAGE, rende Navitor disponibile in Europa per tutte le categorie di rischio chirurgico.
Lo studio VANTAGE ha mostrato risultati eccellenti, tra cui un ridotto tasso del 2,3% di mortalit脿 per tutte le cause o ictus fatale/ictus con disabilit脿, assenza di rigurgito paravalvolare moderato o maggiore a 30 giorni e un tasso di successo tecnico del 97%. Inoltre, la Societ脿 Europea di Cardiologia ha aggiornato le linee guida migliorando le raccomandazioni per le terapie 惭颈迟谤补颁濒颈辫鈩� e 罢谤颈颁濒颈辫鈩� di Abbott nel trattamento delle patologie valvolari cardiache.
Abbott (NYSE:ABT) ha obtenido la aprobaci贸n CE para una indicaci贸n ampliada de su sistema TAVI Navitor鈩� para tratar a pacientes con estenosis a贸rtica grave sintom谩tica que presentan bajo o intermedio riesgo quir煤rgico. Esta ampliaci贸n, respaldada por los datos del ensayo VANTAGE, hace que Navitor est茅 disponible en Europa para todas las categor铆as de riesgo quir煤rgico.
El estudio VANTAGE demostr贸 resultados excelentes, incluyendo una baja tasa del 2,3% de mortalidad por todas las causas o ictus fatal/ictus con discapacidad, ausencia de regurgitaci贸n paravalvular moderada o mayor a los 30 d铆as y una tasa de 茅xito t茅cnico del 97%. Adem谩s, la Sociedad Europea de Cardiolog铆a anunci贸 la actualizaci贸n de sus gu铆as elevando las recomendaciones para las terapias 惭颈迟谤补颁濒颈辫鈩� y 罢谤颈颁濒颈辫鈩� de Abbott en el tratamiento de las enfermedades valvulares cardiacas.
Abbott (NYSE:ABT)電� 歃濎儊鞚� 鞛堧姅 欷戩 雽�霃欕Д韺愲 順戩癌歃� 頇橃瀽 欷� 鞝�鞙勴棙 霕愲姅 欷戧皠鞙勴棙 靾橃垹甑办棎 雽�頃� Navitor鈩� TAVI 鞁滌姢韰�鞚� 鞝侅潙歃� 頇曤寑鞐� 雽�頃� CE 毵堩伂 鞀轨澑鞚� 氚涭晿鞀惦媹雼�. 鞚� 頇曤寑電� VANTAGE 鞁滍棙 雿办澊韯办棎 鞚橅暣 霋冯皼旃悩氅�, Navitor毳� 鞙犽熃 鞝勳棴鞚� 氇摖 靾橃垹 鞙勴棙甑办棎靹� 靷毄頃� 靾� 鞛堧弰搿� 頃╇媹雼�.
VANTAGE 鞐瓣惮電� 鞖办垬頃� 瓴瓣臣毳� 氤挫棳欤检棃電旊嵃, 30鞚� 旮办鞙茧 鞝勳泊 靷 霕愲姅 旃橂獏鞝� 雵岇「欷�/鞛レ暊毳� 霃欕皹頃� 雵岇「欷� 牍勳湪鞚� 2.3%搿� 雮晿瓿�, 欷戨摫霃� 鞚挫儊 PVL(欤茧硛 雸勳稖)鞚� 鞐嗢棃鞙茧┌ 旮办垹鞝� 靹标车毳犾潃 97%鞓�鞀惦媹雼�. 霕愴暅 鞙犽熃鞁灔頃欗殞電� Abbott鞚� 惭颈迟谤补颁濒颈辫鈩� 氚� 罢谤颈颁濒颈辫鈩� 旃橂氩曥棎 雽�頃� 甓岅碃毳� 靸來枼 臁办爼頃� 鞐呺嵃鞚错姼霅� 歆�旃潉 氚滍憸頄堨姷雼堧嫟.
Abbott (NYSE:ABT) a obtenu l'approbation CE pour une indication 茅largie de son syst猫me TAVI Navitor鈩� afin de traiter les patients souffrant de st茅nose aortique s茅v猫re symptomatique pr茅sentant un risque chirurgical faible ou interm茅diaire. Cette extension, appuy茅e par les donn茅es de l'essai VANTAGE, rend Navitor disponible en Europe pour toutes les cat茅gories de risque chirurgical.
L'茅tude VANTAGE a montr茅 d'excellents r茅sultats, notamment un faible taux de 2,3% de mortalit茅 toutes causes ou d'accident vasculaire c茅r茅bral fatal/AVC avec incapacit茅, aucune fuite paravalvulaire mod茅r茅e ou sup茅rieure 脿 30 jours et un taux de succ猫s technique de 97%. Par ailleurs, la Soci茅t茅 europ茅enne de cardiologie a annonc茅 une mise 脿 jour des recommandations, rehaussant les indications pour les th茅rapies 惭颈迟谤补颁濒颈辫鈩� et 罢谤颈颁濒颈辫鈩� d'Abbott dans le traitement des maladies valvulaires cardiaques.
Abbott (NYSE:ABT) hat die CE-Kennzeichnung f眉r eine erweiterte Indikation seines Navitor鈩� TAVI-Systems zur Behandlung symptomatischer, schwerer Aortenstenose bei Patienten mit niedrigem oder intermedi盲rem OP-Risiko erhalten. Diese Erweiterung, gest眉tzt auf die Daten der VANTAGE-Studie, macht Navitor in Europa f眉r alle chirurgischen Risikogruppen verf眉gbar.
Die VANTAGE-Studie zeigte exzellente Ergebnisse, darunter eine
- 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
- None.
Insights
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鈥攁 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
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.
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鈥攁n exceptional outcome compared to historical TAVI data. PVL has been consistently associated with worse long-term outcomes, including increased mortality. The
The
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鈥攁nother critical factor when considering TAVI for lower-risk, typically younger patients with longer life expectancy. The
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 惭颈迟谤补颁濒颈辫鈩� and 罢谤颈颁濒颈辫鈩� for leaky heart valves
ABBOTT PARK, Ill., Aug. 29, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it has received CE Mark in
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
"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
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,听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听Sandra Lesenfants, senior vice president of Abbott's structural heart business. "Aortic stenosis is a听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
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).听
With these updated guidelines, there's additional support for the use of 惭颈迟谤补颁濒颈辫鈩� and 罢谤颈颁濒颈辫鈩� 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
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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鈥�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鈥�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鈥�1705; doi: 10.1056/NEJMoa1814052.
4听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鈥�2074.
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