Terumo Neuro Receives FDA Approval for Carotid Stent System
Terumo Neuro has achieved a significant milestone with FDA Premarket Approval (PMA) for its Carotid Stent System, marking the first dual-layer micromesh carotid stent approved in the United States. The innovative device is designed for treating carotid artery stenosis in patients who face increased risks from traditional carotid endarterectomy procedures.
The stent system is specifically indicated for treating patients with de novo atherosclerotic or post-endarterectomy restenotic lesions in internal carotid arteries or at the carotid bifurcation. It can be used in symptomatic patients with ≥50% stenosis or asymptomatic patients with ≥80% stenosis, as confirmed by angiography. The device is compatible with vessel reference diameters ranging from 3.5 mm to 9.0 mm at the target lesion.
Terumo Neuro ha raggiunto un traguardo importante ottenendo l'approvazione FDA Premarket Approval (PMA) per il suo Carotid Stent System, diventando il primo stent carotideo a doppio strato micromesh approvato negli Stati Uniti. Questo dispositivo innovativo è progettato per trattare la stenosi dell'arteria carotide in pazienti che presentano rischi elevati con le procedure tradizionali di endoarterectomia carotidea.
Il sistema di stent è indicato specificamente per il trattamento di pazienti con lesioni aterosclerotiche de novo o restenotiche post-endoarterectomia nelle arterie carotidi interne o alla biforcazione carotidea. Può essere utilizzato in pazienti sintomatici con stenosi ≥50% o in pazienti asintomatici con stenosi ≥80%, confermate tramite angiografia. Il dispositivo è compatibile con diametri di riferimento del vaso che variano da 3,5 mm a 9,0 mm nella lesione target.
Terumo Neuro ha alcanzado un hito importante con la aprobación Premarket Approval (PMA) de la FDA para su Sistema de Stent Carotídeo, marcando el primer stent carotídeo de micromalla de doble capa aprobado en Estados Unidos. Este innovador dispositivo está diseñado para tratar la estenosis de la arteria carótida en pacientes que presentan riesgos elevados con los procedimientos tradicionales de endarterectomía carotídea.
El sistema de stent está indicado específicamente para tratar a pacientes con lesiones ateroscleróticas de novo o restenóticas post-endarterectomía en las arterias carótidas internas o en la bifurcación carotídea. Puede usarse en pacientes sintomáticos con estenosis ≥50% o en pacientes asintomáticos con estenosis ≥80%, confirmadas mediante angiografía. El dispositivo es compatible con diámetros de referencia del vaso que van de 3,5 mm a 9,0 mm en la lesión objetivo.
Terumo Neuro는 FDA 사전시장 승인(PMA)을 획득하며 미국에서 최초로 이중층 마이크로메쉬 경동맥 스텐트가 승인되는 중요한 이정표를 달성했습니다. 이 혁신적인 장치는 전통적인 경동맥 내막 절제술에서 위험이 높은 환자의 경동맥 협착증 치료를 위해 설계되었습니다.
이 스텐트 시스템은 신생 동맥경화성(de novo atherosclerotic) 병변 또는 내막 절제술 후 재협착 병변이 있는 내경동맥 또는 경동맥 분기부의 환자 치료에 특화되어 있습니다. 혈관조영술로 확인된 증상이 있는 환자의 경우 협착이 50% 이상, 무증상 환자의 경우 80% 이상일 때 사용할 수 있습니다. 이 장치는 목표 병변 부위 혈관 직경이 3.5mm에서 9.0mm 사이인 경우에 적합합니다.
Terumo Neuro a franchi une étape importante en obtenant l'approbation Premarket Approval (PMA) de la FDA pour son Système de Stent Carotidien, devenant ainsi le premier stent carotidien à double couche micromaille approuvé aux États-Unis. Ce dispositif innovant est conçu pour traiter la sténose de l'artère carotide chez les patients présentant des risques accrus liés aux procédures traditionnelles d'endartectomie carotidienne.
Le système de stent est spécifiquement indiqué pour le traitement des patients présentant des lésions athérosclérotiques de novo ou des lésions restenotiques post-endartectomie au niveau des artères carotides internes ou de la bifurcation carotidienne. Il peut être utilisé chez les patients symptomatiques avec une sténose ≥50 % ou chez les patients asymptomatiques avec une sténose ≥80 %, confirmée par angiographie. Le dispositif est compatible avec des diamètres de référence des vaisseaux allant de 3,5 mm à 9,0 mm au niveau de la lésion ciblée.
Terumo Neuro hat einen bedeutenden Meilenstein erreicht, indem es die FDA-Premarket-Zulassung (PMA) für sein Carotid Stent System erhalten hat – das erste duale Mikromesh-Carotis-Stent, das in den Vereinigten Staaten zugelassen wurde. Das innovative Gerät ist für die Behandlung der Carotisstenose bei Patienten konzipiert, die ein erhöhtes Risiko bei herkömmlichen Carotis-Endarterektomie-Verfahren haben.
Das Stentsystem ist speziell zur Behandlung von Patienten mit de novo atherosklerotischen oder post-Endarterektomie-restenotischen Läsionen in den inneren Carotisarterien oder an der Carotisgabelung indiziert. Es kann bei symptomatischen Patienten mit ≥50% Stenose oder asymptomatischen Patienten mit ≥80% Stenose eingesetzt werden, bestätigt durch Angiographie. Das Gerät ist kompatibel mit Gefäßreferenzdurchmessern von 3,5 mm bis 9,0 mm an der Zielstelle.
- First dual-layer micromesh carotid stent to receive FDA approval in the U.S.
- Expands treatment options for high-risk carotid artery disease patients
- Wide range of vessel compatibility (3.5mm to 9.0mm)
- None.
First Dual-Layer Micromesh Carotid Stent Approved for Use in the
Terumo Neuro's Carotid Stent System is indicated for the treatment of carotid artery stenosis in patients at increased risk for adverse events following carotid endarterectomy. The device is intended to treat patients with de novo atherosclerotic or post-endarterectomy restenotic lesions in the internal carotid arteries or at the carotid bifurcation, with ≥
About Terumo Neuro (Formerly MicroVention, Inc.)
We are in business to create and deliver Game-changing Impact™—innovations that redefine what is possible in neuroendovascular treatment to meaningfully advance both physician practice and patient outcomes. Founded in 1997 as MicroVention and acquired by Terumo Corporation in 2006, Terumo Neuro offers more than thirty products for the treatment of cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations. Headquartered in
About Terumo Corporation
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for one hundred years. Based in
Media Contact:
Christine McCullough
Global Corporate Communications
Terumo Neuro
+ 1 714 206 9800
christine.mccullough@microvention.com
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SOURCE Terumo Neuro
FAQ
What is unique about Terumo Neuro's newly FDA-approved Carotid Stent System (TRUMY)?
What patient conditions is the Terumo Neuro Carotid Stent System (TRUMY) approved to treat?
What vessel sizes can Terumo's new Carotid Stent System (TRUMY) accommodate?
What types of lesions can be treated with the Terumo Neuro Carotid Stent System (TRUMY)?
