Perfuze has today announced the receipt of US Food and Drug Administration (FDA) 510(k) clearance for the Millipede88 aspiration catheter.
This clearance follows the successful completion of the MARRS clinical study—which met all of its primary objectives—and, according to the company, positions Perfuze as a leader in the super-bore aspiration segment of the mechanical thrombectomy market.
“The MARRS study results speak for themselves. A 96% deliverability rate for a super-bore catheter is among the best reported in its class, and a 77% first-pass effect in M1 occlusions is something the stroke community has not previously seen in an independently adjudicated thrombectomy trial,” said MARRS principal investigator Raul Nogueira (University of Pittsburgh Medical Center [UPMC], Pittsburgh, USA). “Millipede88’s corrugated design helps preserve lumen integrity in tortuous anatomy, where conventional catheters can ovalise, enabling more consistent clot removal. In stroke—where every minute of delay costs brain tissue—technology that improves the likelihood of achieving reperfusion on the first pass represents a meaningful advance.”
A standalone direct aspiration indication means physicians can achieve reperfusion with the Millipede88 device alone, potentially reducing procedural complexity, lowering per-case device costs, and saving critical minutes for patients, Perfuze further claims in today’s press release.
With this clearance, Millipede88 marks Perfuze’s entry into the super-bore aspiration category as the first standalone 0.088-inch catheter indicated for direct aspiration, bringing its distinctive, patented corrugated technology to “a segment where no comparable solution currently exists”, the release adds.
“US FDA clearance of the Millipede88 aspiration catheter is a defining moment for Perfuze and for the field of stroke intervention,” said Perfuze chief executive officer (CEO) Wayne Allen. “The MARRS study confirms what our team believed throughout development—that the corrugated design enables excellent first-pass reperfusion rates. With no other 0.088 catheter incorporating this technology, we believe Millipede88 will deliver meaningful clinical outcomes in everyday stroke procedures.”
Perfuze says that this Millipede88 clearance builds on the company’s growing regulatory and commercial momentum in the USA, complementing the recently cleared Zipline access catheter family. Together, these products form “an integrated neurovascular portfolio designed to support physicians at every step of the mechanical thrombectomy procedure, from access to reperfusion”.
Perfuze will initiate a limited market release of the Millipede88 aspiration catheter in select US comprehensive stroke centres, with broader commercialisation to follow.
