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April 15, 2025
Terumo Neuro’s Carotid Stent System Receives FDA Approval
April 15, 2025—Terumo Neuro, a wholly owned subsidiary of Terumo Corporation, announced that the company’s dual-layer micromesh carotid stent system has received premarket approval from the FDA for the treatment of carotid artery disease.
As stated in the press release, Terumo Neuro’s carotid stent system is indicated for the treatment of carotid artery stenosis in patients at increased risk for adverse events after carotid endarterectomy.
The device is intended to treat patients with de novo atherosclerotic or postendarterectomy 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 and 9 mm at the target lesion, advised Terumo Neuro.
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