Terumo Neuro, a global leader in neurovascular innovation and a wholly owned subsidiary of Terumo Corporation, today announced that their Carotid Stent System has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA).

This milestone marks the first dual-layer micromesh carotid stent approved in the United States, offering physicians a clinically proven option to improve patient outcomes in carotid artery disease treatment. Terumo Neuro’s Carotid Stent System is indicated for the treatment of carotid artery stenosis in patients at increased risk for adverse events following carotid endarterectomy. The device is intended to treat patients with de novo atherosclerotic or post-endarterectomy restenotic lesions in the internal carotid arteries or at the carotid bifurcation, with ≥50% stenosis in symptomatic patients or ≥80% stenosis in asymptomatic patients, as determined by angiography. The device accommodates vessel reference diameters between 3.5 mm and 9.0 mm at the target lesion.