Perfuze’s Millipede Aspiration and Access Catheters Cleared by FDA for Neurovascular Interventions

Perfuze announced that the second generation of its Millipede 088 access catheter (Perfuze, Galway, Ireland) and its Millipede 070 aspiration catheter (Perfuze, Galway, Ireland) have received Food and Drug Administration (FDA) 510(k) clearance. The Galway, Ireland-based medical device company is developing technology to treat acute ischemic stroke.

According to Perfuze, the Millipede 088 device, which initially received FDA clearance in 2022, facilitates the safe insertion and guidance of microcatheters for neurointerventional or diagnostic procedures. It first received European CE Mark approval in 2021.

The Millipede 070 aspiration catheter is intended for the rapid, safe removal of clots. The company designed the device to provide superior deliverability and high procedural efficiency. The device’s rib-and-recess surface architecture is intended to improve navigability and reduce tip stiffness while maintaining durability.

“In our initial experience with Millipede 070, the system easily delivered to the target occlusion allowing rapid, effective, and safe reperfusion,” commented David Fiorella, MD, in the company’s press release. Dr. Fiorella is Director of the Stony Brook Cerebrovascular Center in Stony Brook, New York.

Perfuze is currently enrolling patients for the MARRS pivotal clinical study, which will support regulatory submissions for the Millipede system. The company recently announced commencement of the study.

Neurointerventional news coverage produced in conjunction with Endovascular Today.