Medical device company, Perfuze, announced it has received FDA 510(k) clearance for the Millipede88 Aspiration Catheter. The clearance follows the successful completion of the MARRS (Millipede AspiRation for Revascularization in Stroke) clinical study, which met all primary objectives.
A standalone direct aspiration indication means physicians can achieve reperfusion with the Millipede88 alone, potentially reducing procedural complexity, lowering per-case device costs, and saving critical minutes for patients. “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,” said Raul Nogueira, MARRS Principal Investigator.
According to a company press release, the Millipede88 Aspiration Catheter is a patented corrugated catheter architecture that represents a fundamental advance in aspiration catheter design. The Millipede88’s corrugated structure 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. Perfuze claims, the result is a catheter engineered to achieve high first-pass reperfusion rates and short procedure times as shown in the MARRS clinical trial, two of the most critical clinical parameters in mechanical thrombectomy.
With this clearance, Millipede88 marks Perfuze’s entry into the super-bore aspiration category as the first standalone 088 catheter indicated for direct aspiration, bringing its distinctive, patented corrugated technology to a segment where no comparable solution currently exists, according to the company.
“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.”
According to Wayne Allen, CEO of Perfuze, the FDA clearance is a defining moment for Perfuze and for the field of stroke intervention. He said, “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 will initiate a Limited Market Release of the Millipede88 Aspiration Catheter in select U.S. Comprehensive Stroke Centers, with broader commercialization to follow.
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