Perfuze’s Millipede 088 Access Catheter for Acute Ischemic Stroke Receives FDA Clearance

February 16, 2023—Perfuze, an Ireland-based medical device company, announced that its Millipede 088 access catheter was granted United States FDA 510(k) clearance for use in treating acute ischemic stroke.

According to the company, the Millipede 088 access catheter is designed to facilitate the safe insertion and guidance of microcatheters for neurointerventional or diagnostic procedures.

Additionally, Perfuze announced that the first United States procedures using the Millipede 088 were successfully performed by physicians at Stony Brook University Hospital in Stony Brook, New York, and the University of Pittsburgh Medical Center Stroke Institute, Pittsburgh, Pennsylvania.

“We are excited to be one of the first hospitals in the country to use the Millipede 088 access catheter,” commented David Fiorella, MD, Director of the Stony Brook Cerebrovascular Center. “The catheter navigated complex neurovascular anatomy with exceptional ease, offering us a precise and efficient means of delivering devices to the brain. I am impressed with my first experience, and I am eager to incorporate this innovative technology in my future cases.”

Last year, Perfuze completed a financing round to support the clinical study of the Millipede device. The Millipede 088 device received CE Mark approval in May 2021.