The US Food and Drug Administration (FDA) has granted 510(k) clearance for Perfuze’s Millipede 088 Access Catheter.
The Millipede 088 Access Catheter has been designed to facilitate the safe insertion and guidance of microcatheters during neuro-interventional or diagnostic procedures.
Physicians at Stony Brook University Hospital, New York, and the University of Pittsburgh Medical Center (UPMC) Stroke Institute, Pennsylvania, performed the first US clinical procedures using the catheter.
The regulatory approval is said to mark a major milestone for Perfuze.
The company is currently working to advance all aspects of stroke treatment, from vessel access to thrombectomy, with a physician-led approach to device innovation.
Perfuze CEO Wayne Allen said: “We are thrilled to have the company’s first FDA clearance in hand and for the initial US procedures to have gone smoothly.
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“Our mission is to improve patient outcomes and provide physicians with better, easier-to-use tools. This regulatory clearance brings us a step closer to achieving that goal.
“Looking ahead, 2023 will be an important year for Perfuze as we move towards initiating our US pivotal study of the Millipede System for revascularisation of patients with acute ischemic stroke.”
The company has also developed super-bore diameter aspiration technology, which is designed to navigate complex neurovascular anatomy.
Its product pipeline is designed to support quick and complete clot removal during acute ischemic stroke.
Last February, Perfuze raised $24.05m (€22.5m) in a Series A financing round to drive the next stage of US clinical studies and regulatory clearance for its Millipede System.