Terumo Neuro (formerly MicroVention) announced today that it received FDA premarket approval (PMA) for its Carotid Stent System.
Aliso Viejo, California-based Terumo Neuro says this marks the first dual-layer micromesh carotid stent approved in the U.S. It offers physicians a clinically proven option to improve patient outcomes in carotid artery disease treatment.
The stent system is indicated for the treatment of carotid artery stenosis in patients at increased risk for adverse events following carotid endarterectomy. Terumo Neuro designed the device to treat patients with de novo atherosclerotic or post-endarterectomy restenotic lesions in the internal carotid arteries or at the carotid bifurcation. The device accommodates vessel reference diameters between 3.5 mm and 9 mm at the target lesion.
This marks another development for Terumo Neuro, which was established through MicroVention’s rebrand last fall.
Microvention — founded in 1997 and acquired by Terumo in 2006 — develops a number of technologies for supporting neurovascular surgeons in preserving and restoring brain health. As Terumo Neuro, the company expects to continue its legacy of innovation and continue to focus on driving impactful growth.
Other previous developments at the company include new product launches and positive study data within the last year. In June 2024, the company began the U.S. launch for its LVIS EVO intraluminal support stent. Then, in July, it reported positive one-year study results supporting the use of its WEB 17 occlusion device.
