Perfuze has announced US Food and Drug Administration (FDA) clearances for the Millipede 070 aspiration catheter and the second-generation of its Millipede 088 access catheter.
The first of these devices, the Millipede 070 aspiration catheter, is intended to remove blood clots rapidly and safely in the treatment of acute ischaemic stroke, as per a Perfuze press release. This “novel, unique” catheter is designed for “superior deliverability and high procedural efficiency” during endovascular thrombectomy procedures, the release adds.
“In our initial experience with Millipede 070, the system easily delivered to the target occlusion, allowing rapid, effective and safe reperfusion,” said David Fiorella (Stony Brook Cerebrovascular Center, Stony Brook, USA).
The release also states that the Millipede 070 device features a rib-and-recess surface architecture designed to improve navigability and reduce tip stiffness while maintaining durability.
“Perfuze aims to provide neurovascular interventionists with innovative thrombectomy solutions, to maximise their opportunity to completely restore blood flow to the brain on their first attempt,” said Wayne Allen, chief executive officer of Perfuze. “The 510(k) clearance for the Millipede 070 aspiration catheter is a key addition to our portfolio of products and is designed to simplify removal of the clot and improve clinical outcomes.”
The company is currently enrolling patients for the MARRS pivotal clinical study, which will support regulatory submissions for the Millipede system.
Additionally, Perfuze recently received 510(k) clearance for its second-generation Millipede 088 access catheter, which is designed to facilitate the safe insertion and guidance of microcatheters for neurointerventional or diagnostic procedures. The Millipede 088 access catheter initially received US FDA 510(k) clearance in 2022.
The release describes these 510(k) clearances as a “major milestone” for the company, underscoring its commitment to “continually advancing the field of neurovascular care”.
