#USA #FDA Approval #Aliso Viejo #Terumo Neuro #Carotid Stent

Terumo Neuro Receives FDA Approval for Carotid Stent System

In a significant stride for neurovascular treatment, Terumo Neuro, a subsidiary of Terumo Corporation, has announced the FDA's Premarket Approval (PMA) for its innovative Carotid Stent System. This pioneering device is notable for being the first dual-layer micromesh carotid stent to earn approval in the United States.

What Sets the Carotid Stent System Apart?

The Carotid Stent System has been specifically designed to improve outcomes for patients suffering from carotid artery disease. It is suitable for individuals who are at an elevated risk of complications following carotid endarterectomy, a surgical procedure used to reduce the risk of stroke by correcting stenosis in the common carotid artery. The stent addresses both de novo atherosclerotic lesions and post-endarterectomy restenotic lesions, effectively accommodating internal carotid arteries with at least 50% stenosis in symptomatic patients or at least 80% stenosis in asymptomatic patients as identified through angiography. The device can be utilized for vessels with diameters ranging from 3.5 mm to 9.0 mm, making it versatile in its application.

A Step Forward in Patient Care

The introduction of this dual-layer micromesh stent is a critical advancement for both physicians and patients. With rigorous clinical trials proving its efficacy, the Carotid Stent System is anticipated to significantly enhance treatment outcomes.

The innovation does not only benefit the patients but also empowers healthcare professionals with a reliable tool to manage complex carotid artery issues. The dual-layer micromesh design aims to provide better support and reduce risks of complications associated with traditional stents.

About Terumo Neuro

Founded in 1997 as MicroVention, Terumo Neuro was acquired by the Terumo Corporation in 2006, becoming a leader in neurovascular innovation. The company is dedicated to creating impactful medical solutions with more than thirty products aimed at treating conditions such as cerebral aneurysms, ischemic strokes, carotid artery diseases, and neurovascular malformations. With headquarters in California and manufacturing capabilities in both California and Costa Rica, Terumo Neuro products are distributed across over seventy countries through direct sales and strategic partnerships.

Terumo Corporation’s Legacy

Established over a century ago, Terumo Corporation has grown from a Japanese thermometer manufacturer to a global leader in medical technology. Their commitment to healthcare has expanded into various fields, including vascular intervention and cardiology. With more than 30,000 employees worldwide, Terumo is devoted to providing innovative solutions and improving the quality of life for patients globally.

In summary, Terumo Neuro's FDA approval for their Carotid Stent System is a monumental step in neurovascular treatment, bringing hope to countless patients at risk of stroke due to carotid artery disease. For more information about their innovative products and services, visit Terumo Neuro's website.