Terumo Interventional Systems Announces Commercial Availability of Its ROADSAVER™ Carotid Stent System
Terumo Interventional Systems (TRUMY) has announced the commercial launch of its FDA-approved ROADSAVER™ Carotid Stent System. This innovative device features a unique dual-layer micromesh design, making it the first of its kind approved in the United States. The stent combines the benefits of a closed-cell structure with open-cell flexibility, designed to prevent plaque protrusion and protect against distal embolization.
The system is available in sizes from 5-10mm width and 22-47mm length, with a 143cm rapid-exchange shaft. Key features include full re-sheathability even after 50% deployment, low-profile 5Fr design, and enhanced crossability. The product will begin limited market release in summer 2025, followed by full market release in fall 2025.
Terumo Interventional Systems (TRUMY) ha annunciato il lancio commerciale del suo ROADSAVER™ Carotid Stent System, approvato dalla FDA. Questo dispositivo innovativo presenta un design unico a doppio strato micromesh, diventando il primo del suo genere approvato negli Stati Uniti. Lo stent unisce i vantaggi di una struttura a cellule chiuse con la flessibilità delle cellule aperte, progettato per prevenire la protrusione della placca e proteggere dall'embolia distale.
Il sistema è disponibile in dimensioni da 5 a 10 mm di larghezza e da 22 a 47 mm di lunghezza, con un'asta a scambio rapido di 143 cm. Le caratteristiche principali includono la completa riavvolgibilità anche dopo il 50% del dispiegamento, un design a basso profilo da 5Fr e una migliore capacità di attraversamento. Il prodotto inizierà un rilascio limitato sul mercato nell'estate 2025, seguito da un rilascio completo in autunno 2025.
Terumo Interventional Systems (TRUMY) ha anunciado el lanzamiento comercial de su ROADSAVER™ Carotid Stent System, aprobado por la FDA. Este dispositivo innovador cuenta con un diseño único de micromalla de doble capa, siendo el primero de su tipo aprobado en Estados Unidos. El stent combina los beneficios de una estructura de células cerradas con la flexibilidad de células abiertas, diseñado para prevenir la protrusión de placa y proteger contra la embolización distal.
El sistema está disponible en tamaños de 5 a 10 mm de ancho y de 22 a 47 mm de largo, con un eje de intercambio rápido de 143 cm. Las características clave incluyen la capacidad de reembolsar completamente incluso después del 50% del despliegue, un diseño de bajo perfil de 5Fr y una mayor capacidad de cruce. El producto comenzará un lanzamiento limitado en el mercado en el verano de 2025, seguido de un lanzamiento completo en otoño de 2025.
Terumo Interventional Systems (TRUMY)는 FDA 승인을 받은 ROADSAVER™ 경동맥 스텐트 시스템의 상업적 출시를 발표했습니다. 이 혁신적인 장치는 독특한 이중층 마이크로메쉬 디자인을 특징으로 하며, 미국에서 처음으로 승인된 제품입니다. 이 스텐트는 폐쇄형 셀 구조의 장점과 개방형 셀의 유연성을 결합하여 플라크 돌출을 방지하고 원위 색전증으로부터 보호하도록 설계되었습니다.
시스템은 폭 5-10mm, 길이 22-47mm 크기로 제공되며, 143cm의 빠른 교환 샤프트를 갖추고 있습니다. 주요 특징으로는 50% 배치 후에도 완전 재수납 가능, 저프로파일 5Fr 디자인, 향상된 관통성이 포함됩니다. 제품은 2025년 여름 제한된 시장 출시를 시작하며, 2025년 가을에 전체 시장 출시가 예정되어 있습니다.
Terumo Interventional Systems (TRUMY) a annoncé le lancement commercial de son ROADSAVER™ Carotid Stent System, approuvé par la FDA. Ce dispositif innovant présente un design unique à double couche micromaille, devenant le premier de ce type approuvé aux États-Unis. Le stent combine les avantages d'une structure à cellules fermées avec la flexibilité des cellules ouvertes, conçu pour prévenir la protrusion de la plaque et protéger contre l'embolie distale.
Le système est disponible en tailles allant de 5 à 10 mm de largeur et de 22 à 47 mm de longueur, avec une tige à échange rapide de 143 cm. Les caractéristiques clés incluent une ré-enroulabilité complète même après 50 % de déploiement, un design à faible profil 5Fr et une meilleure capacité de franchissement. Le produit débutera une commercialisation limitée à l'été 2025, suivie d'une mise sur le marché complète à l'automne 2025.
Terumo Interventional Systems (TRUMY) hat die Markteinführung seines von der FDA zugelassenen ROADSAVER™ Carotid Stent Systems angekündigt. Dieses innovative Gerät verfügt über ein einzigartiges duales Mikromesh-Design und ist das erste seiner Art, das in den USA zugelassen wurde. Der Stent kombiniert die Vorteile einer geschlossenen Zellstruktur mit der Flexibilität offener Zellen und ist darauf ausgelegt, Plaquevorwölbungen zu verhindern und vor distaler Embolisierung zu schützen.
Das System ist in Größen von 5 bis 10 mm Breite und 22 bis 47 mm Länge erhältlich und verfügt über eine 143 cm lange Rapid-Exchange-Achse. Zu den Hauptmerkmalen gehören vollständige Rückziehbarkeit auch nach 50 % Entfaltung, ein niedrigprofiliges 5Fr-Design und verbesserte Durchgängigkeit. Die Produkteinführung auf dem Markt beginnt im Sommer 2025 mit einer limitierten Freigabe, gefolgt von einer vollständigen Markteinführung im Herbst 2025.
- First dual-layer micromesh carotid stent approved in the US market
- Innovative design combining closed-cell structure with open-cell flexibility
- Fully re-sheathable and repositionable even after 50% deployment
- Clinical trials demonstrated safety and effectiveness with low complication rates
- Limited market release initially, restricting immediate widespread availability
- Requires specific patient criteria and has multiple contraindications
– Innovative, dual-layer micromesh, closed-cell stent with the flexibility of an open-cell stent for maximizing clinical outcomes in carotid artery stenting procedures –
ROADSAVER Stent System is the only carotid artery stenting (CAS) device with an innovative, dual-layer micromesh. It is designed as a closed-cell stent with the flexibility of an open-cell stent, providing increased flexibility and wall apposition in complex anatomies. It is also the first dual-layer micromesh carotid stent approved in
Available in sizes from 5 to 10 mm in width and 22 to 47 mm in length, ROADSAVER Stent System has a rapid-exchange shaft length of 143 cm. It is also fully re-sheathable and repositionable – even after
"ROADSAVER Stent System is yet another example of our unrelenting pursuit of achieving better outcomes for patients," said Chris Pearson, Executive Vice President – US Commercial Operations, Terumo Interventional Systems. "Its rapid delivery and accurate placement drive procedure predictability and efficiency, differentiating it from other carotid artery stents on the market and providing a level of confidence unmatched in the industry."
"An inner micromesh layer with a pore size four-times smaller than any carotid stent which provides sustained embolic protection makes the ROADSAVER Stent System a leading technology in the evolution of CAS," said Michael J. Martinelli, MD, FACC, FSCAI and Chief Medical Officer, Terumo Medical Corporation. "This is supported by the results of clinical trials, which demonstrated that using ROADSAVER for symptomatic patients with high-risk lesions is safe and effective, with a low complication rate."
Limited market release of the ROADSAVER Carotid Stent System is planned for summer 2025, with full market release anticipated in fall 2025.
About Terumo Interventional Systems
Terumo Interventional Systems (TIS), a division of Terumo Corporation, is a market leader in minimally invasive entry site management, lesion access, and therapeutic intervention. TIS offers a complete, solution-based product portfolio used in advanced coronary, peripheral and endovascular treatments with strategic initiatives in Transradial Access, Complex Coronary Intervention, Peripheral Artery Disease and Embolotherapy. TIS combines innovative research and development with a deep market understanding to create a pipeline of industry-leading devices that deliver clinical value, economic benefit, and enhanced patient outcomes.
About Terumo
Terumo (TSE:4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for over 100 years. Based in
ROADSAVER
INDICATIONS FOR USE
The Roadsaver Carotid Stent System, when used in conjunction with the Nanoparasol Embolic Protection System (EPS), is indicated for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy and meet the criteria outlined below:
- Patients who have either de novo atherosclerotic or post endarterectomy restenotic lesion(s) in the internal carotid arteries or at the carotid bifurcation with ≥
50% stenosis if symptomatic or ≥80% stenosis if asymptomatic (both defined by angiography),
AND - Patients having a vessel with reference diameters between 3.5 mm and 9.0 mm at the target lesion.
CONTRAINDICATIONS
The Roadsaver Carotid Stent System is contraindicated for use in:
- Patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs are contraindicated
- Patients with known hypersensitivity to nickel-titanium
- Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system, or stent system
- Patients with uncorrected bleeding disorders
- Lesions in the ostium of the common carotid artery
- Carotid vessel with <25mm gap between the target location of the distal end of the stent and the proximal end of the distal protection device.
NANOPARASOL EPS
INDICATIONS FOR USE
The Nanoparasol EPS is indicated for use as a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the filter placement should be between 3.0 and 6.5 mm.
CONTRAINDICATIONS
The Nanoparasol EPS is contraindicated for use in:
- Patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs is contraindicated
- Patients with known hypersensitivity to nickel-titanium
- Patients with severe vascular tortuosity or anatomy that would preclude the landing zone requirement or the
safe introduction of a guide wire, guide catheter, introducer sheath, an embolic protection device, delivery
catheter, or retrieval catheter - Patients with uncorrected bleeding disorders
- Lesions in the ostium of the common carotid artery
RX ONLY. Refer to the product labels and package insert for complete contraindications, warnings, precautions, potential complications, and instructions for use.
Manufacturer: Terumo Neuro, 35 Enterprise,
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All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties.
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SOURCE Terumo Interventional Systems
FAQ
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