Medical device company Perfuze reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) Breakthrough Device Designation for its Millipede CIS technology.
According to the company, Millipede CIS is an innovative catheter technology that is designed to remove clots from the brain following an acute ischemic stroke. The technology aims to provide superior clinical outcomes in shorter procedural times, resulting in safe, cost-effective therapy.
The FDA's Breakthrough Device Designation recognises the novelty of the company's Millipede technology and its potential to offer significant advantages over existing alternatives for treatment of acute ischemic stroke. The goal is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval, 510(k) clearance and de novo marketing authorisation.
An ischemic stroke occurs when a blood vessel in the brain is blocked by a clot, preventing blood flow. Stroke is the second leading global cause of death and a leading cause of disability, according to the World Health Organization (WHO).
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