GALWAY, Ireland--(BUSINESS WIRE)--Perfuze, a medical device company developing next-generation catheter-based technology to treat acute ischemic stroke, has been granted Breakthrough Device Designation by the U.S. FDA for its Millipede CIS technology.
Millipede CIS is an innovative catheter technology that is designed to remove clots from the brain following an acute ischemic stroke. The designation recognizes the novelty of the Millipede technology and its potential to offer significant advantages over existing alternatives for treatment of acute ischemic stroke.
Breakthrough Device Designation from the FDA is granted to certain medical devices that provide for a more effective treatment of life-threatening or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program 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 authorization.
According to WHO, stroke is the second leading global cause of death and a leading cause of disability. An ischemic stroke occurs when a blood vessel in the brain is blocked by a clot, preventing blood flow. Perfuze’s technology aims to provide superior clinical outcomes in shorter procedural times, resulting in safe, cost-effective therapy.
Perfuze was founded in 2018 by Wayne Allen and Liam Mullins. The founders have over 30 years combined medtech experience within start-up and large corporations. Perfuze is located in the IDA Business Park in Dangan, Galway, Ireland. www.perfuze.com