Perfuze Millipede Catheter Gains FDA Clearance for Treating Ischemic Stroke

Perfuze announced that its Millipede 088 Access Catheter — which gained Breakthrough Device status from the FDA in 2019 — has now been cleared by the agency to treat acute ischemic stroke and has been used successfully in surgeries at two U.S. hospitals.

The catheter is designed to allow the surgeon to navigate the complex neurovascular anatomy and allow safe insertion and guidance of microcatheters for neurointerventional or diagnostic procedures.

The catheter offers “a precise and efficient means of delivering devices to the brain,” said David Fiorella, Director of the Stony Brook Cerebrovascular Center, NY, one of the two hospitals to use the device.

The company says it will be initiating an additional study in the U.S. this year.