Perfuze Announces Final MARRS Results: Strong Reperfusion and First-Pass Performance in Pivotal Stroke Trial

“Independently adjudicated MARRS data show standalone Perfuze super-bore aspiration delivers a 75% first-pass effect in MCA M1 occlusions”

GALWAY, Ireland--(BUSINESS WIRE)--Perfuze, a medical device company advancing stroke treatment through next-generation catheter technology, today announced publication of the final results of the MARRS pivotal study in the Journal of Neurointerventional Surgery. The trial met its primary endpoint, with successful reperfusion mTICI 2b-3 achieved in 89% of patients without rescue therapy - exceeding the prespecified performance goal. The study also demonstrated a 75% first-pass effect mTICI 2c-3 in middle cerebral artery M1 occlusions¹ and 96% delivery success using Millipede88.

MARRS was a prospective, multicenter, single-arm pivotal study of the Millipede® Aspiration System in 180 patients across 22 hospitals in the United States and Europe, conducted under a U.S. FDA Investigational Device Exemption with all imaging and safety endpoints independently adjudicated (NCT05714501). The data supported the FDA 510(k) clearance of the Millipede88 Aspiration Catheter.

The results support standalone direct aspiration with a super-bore 0.088″ catheter powered by patented Corrugated™ technology. Direct aspiration with Millipede88 succeeded without the need for adjunctive devices such as stent retrievers in the large majority of cases, with rescue therapy required in under 8% of Millipede88 cases. The study demonstrated a favorable safety profile, with a 2.3% symptomatic intracranial hemorrhage rate, no vessel perforations, and no device-related serious adverse events.

“In large vessel occlusion stroke, the first pass is where outcomes are decided,” said Raul G. Nogueira, MD, a Principal Investigator of MARRS, University of Pittsburgh Medical Center. “The first-pass effect and successful reperfusion rates in MARRS, which are based on independent core lab adjudication, are the highest rates reported to date in a prospective thrombectomy study.”

The Millipede’s Corrugated™ catheter architecture differs from the coiled or braided construction of conventional aspiration catheters, preserving inner lumen integrity to maintain aspiration force at the face of the clot.

“The final MARRS results support the design philosophy behind the Millipede system — that a super-bore catheter engineered from first principles may simplify stroke intervention while raising the bar on reperfusion,” said Wayne Allen, CEO of Perfuze. “A 75% first-pass effect in M1 occlusions, achieved with standalone direct aspiration, is a clinically meaningful result for first-line aspiration. These data position Perfuze as a leader in the super-bore aspiration segment as we expand access to Corrugated™ technology.”

As leading stroke centers increasingly adopt aspiration-first as their default approach, super-bore aspiration has become the fastest-growing segment of the mechanical thrombectomy market. The Millipede88 Catheter enters this segment with patented technology and a large, independently adjudicated prospective dataset behind it. Together with the recently cleared Zipline® Access Catheter, it forms an integrated system designed for high first-pass effect with efficiency. Perfuze continues its Limited Market Release of the Millipede88 Aspiration System in select U.S. Comprehensive Stroke Centers, with broader commercialization to follow.

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. Its growing neurovascular portfolio, including the Millipede88 Aspiration Catheter, Millipede70® Aspiration Catheter, and Zipline® Access Catheter family reflects a commitment to meaningful innovation at the frontier of stroke intervention. For more information, visit www.perfuze.com.

Media Contact: Dr. Freskida Goni · freskida.goni@perfuze.com · +44 7473 678178