Terumo Neuro has announced that its carotid stent system has received premarket approval (PMA) from the US Food and Drug Administration (FDA).
This milestone marks the first dual-layer micromesh carotid stent approved in the USA, offering physicians a clinically proven option to improve patient outcomes in carotid artery disease treatment, as per a Terumo Neuro press release.
The company’s carotid stent system is indicated for the treatment of carotid artery stenosis in patients at increased risk for adverse events following a carotid endarterectomy procedure.
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.
According to Terumo Neuro’s recent release, the device also accommodates vessel reference diameters between 3.5mm and 9mm at the target lesion.
