Terumo Neuro Receives FDA Approval for Carotid Stent System

Terumo Neuro has achieved a significant milestone with FDA Premarket Approval (PMA) for its Carotid Stent System, marking the first dual-layer micromesh carotid stent approved in the United States.

Rhea-AI Summary

Terumo Neuro has achieved a significant milestone with FDA Premarket Approval (PMA) for its Carotid Stent System, marking the first dual-layer micromesh carotid stent approved in the United States. The innovative device is designed for treating carotid artery stenosis in patients who face increased risks from traditional carotid endarterectomy procedures.

The stent system is specifically indicated for treating patients with de novo atherosclerotic or post-endarterectomy restenotic lesions in internal carotid arteries or at the carotid bifurcation. It can be used in symptomatic patients with ≥50% stenosis or asymptomatic patients with ≥80% stenosis, as confirmed by angiography. The device is compatible with vessel reference diameters ranging from 3.5 mm to 9.0 mm at the target lesion.

Positive

• First dual-layer micromesh carotid stent to receive FDA approval in the U.S.
• Expands treatment options for high-risk carotid artery disease patients
• Wide range of vessel compatibility (3.5mm to 9.0mm)

Negative

• None.

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First Dual-Layer Micromesh Carotid Stent Approved for Use in the U.S.

ALISO VIEJO, Calif., April 15, 2025 /PRNewswire/ -- 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.

About Terumo Neuro (Formerly MicroVention, Inc.)

We are in business to create and deliver Game-changing Impact™—innovations that redefine what is possible in neuroendovascular treatment to meaningfully advance both physician practice and patient outcomes. Founded in 1997 as MicroVention and acquired by Terumo Corporation in 2006, Terumo Neuro offers more than thirty products for the treatment of cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations. Headquartered in California, Terumo Neuro products are sold in more than seventy countries through a direct sales organization as well as strategic distribution partnerships. Manufacturing facilities are in Aliso Viejo, California, and San José, Costa Rica. For more information on Terumo Neuro, please visit www.terumoneuro.com.

About Terumo Corporation

Terumo (TSE: 4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for one hundred years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice. Terumo will further strive to be of value to patients, medical professionals, and society at large.

Media Contact:
Christine McCullough
Global Corporate Communications
Terumo Neuro
+ 1 714 206 9800
christine.mccullough@microvention.com

FAQ

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What is unique about Terumo Neuro's newly FDA-approved Carotid Stent System (TRUMY)?

It's the first dual-layer micromesh carotid stent approved in the United States, offering a new treatment option for carotid artery disease.

What patient conditions is the Terumo Neuro Carotid Stent System (TRUMY) approved to treat?

It treats carotid artery stenosis in patients with ≥50% stenosis (symptomatic) or ≥80% stenosis (asymptomatic) who are at high risk for carotid endarterectomy.

What vessel sizes can Terumo's new Carotid Stent System (TRUMY) accommodate?

The system is compatible with vessel reference diameters between 3.5 mm and 9.0 mm at the target lesion.

What types of lesions can be treated with the Terumo Neuro Carotid Stent System (TRUMY)?

It treats de novo atherosclerotic lesions and post-endarterectomy restenotic lesions in internal carotid arteries or at the carotid bifurcation.