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Terumo Interventional Systems has announced the early commercial availability of its FDA-approved Roadsaver Carotid Stent System.

The Roadsaver Stent is a dual-layer micromesh device designed to minimize embolic risk during carotid artery stenting (CAS) procedures. It is intended for patients with carotid artery stenosis who face higher risks from carotid endarterectomy, and is to be used alongside the company’s Nanoparasol Embolic Protection System.

The company states that Roadsaver is the only carotid stent in the U.S. market featuring a dual-layer micromesh construction. Although designed as a closed-cell stent, it retains the flexibility commonly found in open-cell designs.

“Roadsaver Stent System is yet another example of our unrelenting pursuit of achieving better outcomes for patients,” said Chris Pearson, executive VP of U.S. commercial operations at 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.”

The device is available in diameters ranging from 5 to 10 mm and lengths from 22 to 47 mm. It also includes a 143 cm rapid-exchange shaft and a 5 Fr profile for enhanced crossability. The stent allows for full re-sheathing and repositioning even after 50% of its length has been deployed.

Michael Martinelli, chief medical officer of Terumo Medical Corporation, highlighted that the stent’s micromesh layer has a pore size that is four times smaller than that of conventional carotid stents, which helps maintain consistent embolic protection.

“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,” said Martinelli. 

Terumo has announced plans for a limited market release of the Roadsaver stent in summer 2025, with a full release expected in the fall.

Source: Terumo