Perfuze Receives FDA Clearance for Millipede88® — the First Super-Bore Aspiration Catheter Cleared for Standalone Direct Aspiration

The Millipede88^® is the first 088 aspiration catheter with patented corrugated technology cleared for standalone direct aspiration — no large-bore intermediary required — backed by independently adjudicated MARRS study data showing a 77% first-pass effect¹ in M1 occlusions and 96% delivery success.

GALWAY, Ireland--(BUSINESS WIRE)--Perfuze, a medical device company dedicated to advancing stroke treatment through next-generation catheter technology, today 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, and positions Perfuze as a leader in the super-bore aspiration segment, the fastest-growing category within the expanding mechanical thrombectomy market. 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.

A New Benchmark in Super-Bore Aspiration Technology

The Millipede88^® Aspiration Catheter introduces a patented corrugated catheter architecture that 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 maintain maximum aspiration force at the face of the clot. 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.

Physician Perspective

"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."

Executive Commentary

"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."

Expanding Perfuze's U.S. Commercial Footprint

The Millipede88^® clearance builds on Perfuze's growing regulatory and commercial momentum in the United States, 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 U.S. Comprehensive Stroke Centers, with broader commercialization to follow.

The super-bore aspiration segment represents the fastest-growing area of the mechanical neurovascular thrombectomy market, as leading stroke centers increasingly adopt aspiration first strategies as their default approach. With the Millipede88^® Aspiration Catheter, Perfuze is positioned to meet this demand with the most technologically advanced offering in the category.

About Perfuze

Perfuze is a medical device company headquartered in Galway, Ireland, dedicated to developing next-generation catheter-based aspiration technology for acute ischemic stroke. The company's proprietary platform is designed to maximize clot removal efficiency, enhance procedural simplicity, and improve clinical outcomes. Perfuze's growing portfolio of neurovascular devices, including the Millipede88^® Aspiration Catheter, Millipede70^® Aspiration Catheter, and Zipline^® Access Catheter family, reflects its commitment to meaningful innovation at the frontier of stroke intervention. For more information, visit www.perfuze.com.

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¹ Rate of First Pass Effect mTICI ≥2c in M1 occlusions when the Millipede88® Aspiration Catheter was used for the first pass.