Perfuze, a medical device company developing next-generation catheter-based technology to treat acute ischemic stroke, has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its Millipede Clot Ingestion System (CIS) technology.
Millipede CIS comprises a catheter technology that is designed to remove clots from the brain following an acute ischemic stroke. The designation recognises 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. According to a press release, 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 authorisation.