Terumo Interventional Systems has announced the early commercial availability of its US Food and Drug Administration (FDA)-approved Roadsaver carotid stent system. Indicated for use with Terumo’s Nanoparasol embolic protection system, Roadsaver is intended to treat carotid artery stenosis in patients with an increased risk of adverse events following carotid endarterectomy (CEA).
“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 [carotid artery stenting],” said Michael Martinelli, chief medical officer of 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.”
Terumo claims that its Roadsaver stent system is the only CAS device with an innovative, dual-layer micromesh—also noting in a recent press release that 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. According to the company, Roadsaver is the first dual-layer micromesh carotid stent approved in the USA as well.
The device’s intended use is to contain plaque to the vessel wall and prevent plaque protrusion, protecting against distal embolisation in carotid artery stenosis patients.
Available in sizes from 5–10mm in width and 22–47mm in length, the Roadsaver stent system has a rapid-exchange shaft length of 143cm. It is fully re-sheathable and repositionable—even after 50% of the stent’s length is deployed—and has a low-profile 5Fr design, which enhances its ‘crossability’, Terumo claims.
“The Roadsaver stent system is yet another example of our unrelenting pursuit of achieving better outcomes for patients,” commented Chris Pearson, executive vice president of US 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.”
A limited market release of the Roadsaver carotid stent system is planned for the summer of 2025, with a full market release anticipated later in the year.
