BY SEAN WHOOLEY

The Millipede catheter.
[Image courtesy of Perfuze]

Perfuze announced today that the FDA cleared its Millipede 070 aspiration catheter and second-generation Millipede 088 access catheter.

Galway, Ireland-based Perfuze developed Millipede 070 to address critical unmet needs in ischemic stroke treatment. It aims to remove clots rapidly and safely through a novel, unique catheter.

Millipede 070 has a unique design with a rib-and-recess surface architecture to improve navigability and reduce tip stiffness while maintaining durability. The design features superior deliverability and high procedural efficiency, enabling a more refined approach for restoring blood flow to the brain during endovascular thrombectomy procedures.

The company currently has enrollment underway for its MARRS pivotal clinical study to support future regulatory submissions.

“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,” said Wayne Allen, CEO. “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.”

Perfuze also received FDA clearance for its second-generation Millipede 088 access catheter. The company designed it to facilitate the safe insertion and guidance of microcatheters for neurointerventional or diagnostic procedures. This catheter initially received FDA clearance in 2022.

The company called the clearances a “major milestone” underscoring its commitment to advancing neurovascular care.