FDA OKs Perfuze’s Millipede88 Aspiration Catheter

Perfuze has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for the Millipede88 aspiration catheter.

The catheter introduces a patented corrugated catheter architecture that the company said represents a fundamental advance in aspiration catheter design. Unlike conventional super-bore catheters, the Millipede88’s corrugated structure is designed to simplify navigation through tortuous neurovascular anatomy and preserve inner lumen integrity to keep maximum aspiration force at the face of the clot.

The result is a catheter that can achieve high first-pass reperfusion rates and short procedure times, as shown in the MARRS clinical trial. The MARRS (Millipede AspiRation for Revascularization in Stroke) study met all primary objectives and granted the standalone direct aspiration indication.

“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 Raul Nogueira, MARRS principal investigator and division chief of Cerebrovascular Medicine at UPMC. “Millipede88’s corrugated design helps preserve lumen integrity in tortuous anatomy, where conventional catheters can ovalize, 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.”

Perfuze will begin a limited market release of the Millipede88 in select U.S. comprehensive stroke centers, with broader commercialization to follow.

“FDA clearance of the Millipede88 Aspiration Catheter is a defining moment for Perfuze and for the field of stroke intervention,” said Wayne Allen, CEO of Perfuze. “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.”