Terumo Interventional Systems has announced the early commercial availability of its FDA-approved Roadsaver Carotid Stent System.
Roadsaver is a dual-layer micromesh carotid stent designed to reduce embolic risk during carotid artery stenting (CAS) procedures. It is indicated for use in patients with carotid artery stenosis who are at increased risk of complications from carotid endarterectomy, and is intended to be used in conjunction with the company’s Nanoparasol Embolic Protection System.
According to the company, Roadsaver is the only carotid stent on the U.S. market with a dual-layer micromesh structure. The device is built as a closed-cell stent but maintains the flexibility typically associated with 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 made with braided nitinol and comes in sizes ranging from 5 to 10 mm in diameter and 22 to 47 mm in length. It features a 143 cm rapid-exchange shaft and a 5 Fr profile for improved crossability. The stent can be fully re-sheathed and repositioned even after 50% of its length has been deployed.
Michael Martinelli, chief medical officer of Terumo Medical Corporation, said the stent’s micromesh layer offers a pore size four times smaller than conventional carotid stents, supporting sustained embolic protection.
Said Martinelli: “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.”
Terumo said a limited market release of the Roadsaver stent is planned for summer 2025, with full market release expected in the fall.
