The Galway, Ireland-based company designed Millipede 088 to facilitate the safe insertion and guidance of microcatheters for neurointerventional or diagnostic procedures. The company hopes the device will advance all aspects of stroke treatment from vessel access through to thrombectomy.
“We are thrilled to have the company’s first FDA clearance in hand and for the initial U.S. procedures to have gone smoothly,” CEO Wayne Allen said in a news release. “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 U.S. pivotal study of the Millipede System for revascularization of patients with acute ischemic stroke.”
The first U.S. clinical procedures with the Millipede 088 access catheter were performed on news of the FDA clearance. The procedure was completed by physicians at Stony Brook University Hospital in Stony Brook, New York and the University of Pittsburgh Medical Center Stroke Institute in Pittsburgh, Pennsylvania.
“We are excited to be one of the first hospitals in the country to use the Millipede 088 access catheter,” said Dr. David Fiorella, 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.”