Sam Brusco, Associate Editor12.20.23
Perfuze has obtained U.S. Food and Drug Administration (FDA) clearance for its Millipede 070 aspiration catheter and the second generation of its Millipede 088 access catheter.
Millipede 070 treats ischemic stroke by safely and quickly removing clots, the company explained, and represents a more refined approach to restore blood flow to the brain during procedures for endovascular thrombectomy.
The aspiration catheter’s design features a rib-and-recess surface architecture to improve navigability and reduce tip stiffness, while maintaining durability.
“In our initial experience with Millipede 070, the system easily delivered to the target occlusion allowing rapid, effective and safe reperfusion,” said David Fiorella, director of the Stony Brook Cerebrovascular Center.
“Perfuze aims to provide neurovascular interventionists with innovative thrombectomy solutions, to maximize their opportunity to completely restore blood flow to the brain on their first attempt,” added Wayne Allen, CEO 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 second-gen Millipede 088 access catheter is used to insert and guide microcatheters for neurointerventional and diagnostic procedures. The first generation device received FDA 510(k) clearance in 2022, three years after achieving FDA breakthrough status.
The company said it’s currently enrolling patients for its MARRS pivotal study, which will support further regulatory submissions for the Millipede line.
Millipede 070 treats ischemic stroke by safely and quickly removing clots, the company explained, and represents a more refined approach to restore blood flow to the brain during procedures for endovascular thrombectomy.
The aspiration catheter’s design features a rib-and-recess surface architecture to improve navigability and reduce tip stiffness, while maintaining durability.
“In our initial experience with Millipede 070, the system easily delivered to the target occlusion allowing rapid, effective and safe reperfusion,” said David Fiorella, director of the Stony Brook Cerebrovascular Center.
“Perfuze aims to provide neurovascular interventionists with innovative thrombectomy solutions, to maximize their opportunity to completely restore blood flow to the brain on their first attempt,” added Wayne Allen, CEO 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 second-gen Millipede 088 access catheter is used to insert and guide microcatheters for neurointerventional and diagnostic procedures. The first generation device received FDA 510(k) clearance in 2022, three years after achieving FDA breakthrough status.
The company said it’s currently enrolling patients for its MARRS pivotal study, which will support further regulatory submissions for the Millipede line.