Perfuze’s Millipede88 Aspiration Catheter Cleared by FDA

March 17, 2026—Perfuze, an Ireland-based developer of catheters for interventional stroke care, announced it has received FDA 510(k) clearance for the Millipede88 aspiration catheter in mechanical neurovascular thrombectomy. The standalone superbore catheter is indicated for direct aspiration.

Perfuze advised that it will initiate a limited market release of the Millipede88 in the United States in select comprehensive stroke centers, with broader commercialization to follow. The Millipede88 joins the company’s Zipline access catheter family, which received FDA clearance in March 2025.

According to the company, the clearance follows the completion of the MARRS pivotal trial of the Millipede device for revascularization in stroke, which met all primary objectives. In July 2025, Perfuze announced that the preliminary results from the trial were presented at SNIS 2025, the Society of NeuroInterventional Surgery’s annual meeting.

The Millipede88 aspiration catheter features a corrugated catheter architecture, which is designed to simplify navigation through tortuous neurovascular anatomy and preserve inner lumen integrity to maintain maximum aspiration force at the face of the clot, noted Perfuze.

The Principal Investigator of MARRS is Raul G. Nogueira, MD, Division Chief of Cerebrovascular Medicine at UPMC and Professor of Neurology and Neurosurgery at the University of Pittsburgh School of Medicine in Pittsburgh, Pennsylvania.

“The MARRS study results speak for themselves,” commented Dr. Nogueira in Perfuze’s press release. “A 96% deliverability rate for a superbore 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.”

Dr. Nogueira continued, “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.”