FDA OKs Terumo Neuro’s Carotid Stent System

Terumo Neuro, a company focused on neurovascular innovation, has received premarket approval from the U.S. Food and Drug Administration for its Carotid Stent System.

This achievement, according to the Terumo subsidiary, marks the first dual-layer micromesh carotid stent approved in the U.S. It can offer a clinically proven option to improve outcomes in carotid artery disease treatment.

The Carotid Stent System is indicated to treat carotid artery stenosis in patients with increased risk of adverse events after carotid endarterectomy. It’s meant 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 mm at the target lesion.

Terumo Neuro was founded in 1997 as MicroVention and was acquired by Terumo in 2006. The company touts more than 30 products to treat cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations.

Headquartered in California, Terumo Neuro products are sold in over seventy countries through a direct sales organization as well as strategic distribution partnerships. Manufacturing facilities are in Aliso Viejo, Calif., and San José, Costa Rica.