Terumo launches ROADSAVER™ carotid stent system for commercial use

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.

More information can be found at www.terumo.com.