Terumo Neuro announced today that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for its Carotid Stent System, introducing the first dual-layer micromesh carotid stent to the U.S. market. This regulatory milestone provides physicians with a novel, clinically proven option for treating patients with carotid artery disease who face increased risk from traditional surgical approaches.
The newly approved device addresses a significant clinical need in the management of carotid artery stenosis, a condition that remains a leading cause of stroke worldwide. The dual-layer micromesh design represents a technological advancement over conventional single-layer carotid stents currently available in the U.S. market.
Clinical Indications and Patient Selection
The Terumo Neuro Carotid Stent System is specifically indicated for patients at elevated risk for adverse events following carotid endarterectomy, the surgical procedure traditionally used to remove plaque from narrowed carotid arteries. The device targets patients with either de novo atherosclerotic lesions or post-endarterectomy restenotic lesions located in the internal carotid arteries or at the carotid bifurcation.
According to the approval, the stent can be used in symptomatic patients with stenosis of 50% or greater and asymptomatic patients with stenosis of 80% or greater, as determined by angiography. The system is designed to accommodate vessel reference diameters ranging from 3.5 mm to 9.0 mm at the target lesion, providing flexibility for various anatomical presentations.
Technical Innovation in Carotid Stenting
The dual-layer micromesh design represents a significant engineering advancement in carotid stent technology. While specific clinical data from the pivotal trials were not detailed in the announcement, the FDA's premarket approval process requires substantial evidence of safety and effectiveness, suggesting the device demonstrated meaningful clinical benefits in the studies submitted for regulatory review.
Traditional carotid stents have faced challenges related to post-procedural embolic events, where plaque particles can escape through the stent struts during or after placement. The dual-layer micromesh architecture likely addresses this limitation by providing enhanced plaque coverage while maintaining vessel patency.
Market Impact and Clinical Significance
This approval positions Terumo Neuro as the first company to offer a dual-layer micromesh carotid stent in the United States, potentially establishing a new standard of care for endovascular treatment of carotid artery disease.
Carotid artery disease affects millions of Americans and is responsible for approximately 15-20% of ischemic strokes. While carotid endarterectomy has been the gold standard treatment for decades, minimally invasive stenting procedures have gained traction, particularly for patients with anatomical or clinical factors that increase surgical risk.
Company Background and Global Presence
Terumo Neuro, formerly known as MicroVention, Inc., has established itself as a significant player in the neurovascular intervention space. Founded in 1997 and acquired by Terumo Corporation in 2006, the company now offers more than thirty products for treating various neurovascular conditions, including cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations.
Headquartered in Aliso Viejo, California, with additional manufacturing facilities in San José, Costa Rica, Terumo Neuro distributes its products in over seventy countries through direct sales and strategic partnerships. The parent company, Terumo Corporation (TSE: 4543), is a Tokyo-based global medical technology leader with more than 30,000 employees worldwide and a century-long commitment to healthcare innovation.
Future Implications for Carotid Disease Management
The introduction of this novel stent system may influence treatment algorithms for carotid artery disease, potentially expanding the population of patients who can benefit from minimally invasive interventions rather than open surgery. As real-world data accumulates following this approval, clinicians will gain better understanding of the device's performance across diverse patient populations and anatomical variations.
For patients with carotid artery disease who are poor candidates for endarterectomy, this new option provides access to advanced technology designed to reduce procedural risks while effectively treating the underlying stenosis. The approval also highlights the continued innovation in endovascular approaches to neurovascular diseases, an area that has seen remarkable technological advancement in recent years.
