Sam Brusco, Associate Editor02.16.23
Perfuze has secured its first clearance from the U.S. Food and Drug Administration (FDA) for its Millipede 088 access catheter. The first U.S. clinical procedures were also performed at Stony Brook University Hospital and the University of Pittsburgh Medical Center (UPMC) Stroke Institute.
"We are excited to be one of the first hospitals in the country to use the Millipede 088 Access Catheter," Dr. David Fiorella, Director of the Stony Brook Cerebrovascular Center told the press. "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."
The Millipeded o88 access catheter facilitates safe insertion and guidance for microcatheters for neurointerventional or diagnostic procedures. Perfuze aims to advance all aspects of stroke treatment from vessel access through to thrombectomy—the 510(k) clearance is a huge milestone for the company.
"We are thrilled to have the company’s first FDA clearance in hand and for the initial U.S. procedures to have gone smoothly," said Wayne Allen, Perfuze CEO. "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."
"We are excited to be one of the first hospitals in the country to use the Millipede 088 Access Catheter," Dr. David Fiorella, Director of the Stony Brook Cerebrovascular Center told the press. "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."
The Millipeded o88 access catheter facilitates safe insertion and guidance for microcatheters for neurointerventional or diagnostic procedures. Perfuze aims to advance all aspects of stroke treatment from vessel access through to thrombectomy—the 510(k) clearance is a huge milestone for the company.
"We are thrilled to have the company’s first FDA clearance in hand and for the initial U.S. procedures to have gone smoothly," said Wayne Allen, Perfuze CEO. "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."