Terumo Interventional Systems Announces Commercial Availability of Its ROADSAVER™ Carotid Stent System

– Innovative, dual-layer micromesh, closed-cell stent with the flexibility of an open-cell stent for maximizing clinical outcomes in carotid artery stenting procedures  –

SOMERSET, N.J., May 28, 2025 /PRNewswire/ -- Terumo Interventional Systems (TIS), a division of Terumo Corporation, is pleased to announce the early commercial availability of its FDA-approved ROADSAVER™ Carotid Stent System. Indicated for use with the Nanoparasol® Embolic Protection System, ROADSAVER Stent System addresses carotid artery stenosis in patients with increased risk of adverse events following carotid endarterectomy.

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 the United States, and the only carotid stent system designed to contain plaque to the vessel wall and prevent plaque protrusion, protecting against distal embolization.

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 50% of the stent's length is deployed. Another important feature is the product's low-profile 5Fr design, which enhances its crossability.

"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 Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large. More information can be found at www.terumo.com.

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:

1. 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
2. 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, Aliso Viejo, CA 92656, USA

Distributed by Terumo Medical Corporation, 265 Davidson Ave, Somerset, NJ 08873, USA

©2025 Terumo Medical Corporation.

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