Perfuze has secured its first product clearance from the US Food and Drug Administration (FDA) for the company’s Millipede 088 access catheter. The first US clinical procedures with Millipede 088 were successfully performed by physicians at Stony Brook University Hospital in New York, USA and the University of Pittsburgh Medical Center (UPMC) Stroke Institute in Pittsburgh, USA.
“We are excited to be one of the first hospitals in the country to use the Millipede 088 access catheter,” said David Fiorella (Stony Brook University Hospital, New York, USA). “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 Millipede 088 access catheter is designed to facilitate the safe insertion and guidance of microcatheters for neurointerventional or diagnostic procedures.
With a physician-led approach to device innovation, Perfuze is working to advance all aspects of stroke treatment from vessel access through to thrombectomy, as per a company press release. This 510(k) clearance is “a major milestone for the company and a testament to its commitment to advancing the field of neurovascular care”, the release states.
“We are thrilled to have the company’s first FDA clearance in hand and for the initial US 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 US pivotal study of the Millipede system for revascularisation of patients with acute ischaemic stroke.”