Terumo Interventional Systems launches dual-layer micromesh carotid stent after FDA approval
Terumo Interventional Systems, a division of Terumo Corporation, has announced that its Roadsaver Carotid Stent System is now commercially available for the first time. The device just gained U.S. Food and Drug Administration (FDA) approval for the treatment of carotid artery stenosis in patients who face a high risk of complications following carotid endarterectomy.
The Roadsaver device works with the company’s Nanoparasol Embolic Protection System. It is a closed-cell stent, but still flexible like an open-cell stent, and available in multiple sizes. It was built to target de novo atherosclerotic or post-endarterectomy restenotic lesions in the internal carotid arteries or at the carotid bifurcation
According to Terumo, Roadsaver is the first dual-layer micromesh carotid stent on the U.S. market. In addition, the company said it is the only device of its kind that prevents plaque protrusion by keeping plaque to the vessel wall.
Chris Pearson, executive vice president of U.S. commercial operations for Terumo Interventional Systems, described the newly available device as “yet another example of our unrelenting pursuit of achieving better outcomes for patients. 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,” he added in a prepared statement.
This is a limited market release of the Roadsaver technology; a full release is expected to occur in the second half of 2025.