Promising Preliminary Results Released in Perfuze’s Millipede88 Catheter Study

Perfuze is sharing positive preliminary results from its pivotal IDE clinical trial, MARRS (Millipede Aspiration for Revascularization in Stroke Study), which is evaluating the safety and effectiveness of the Millipede System for revascularization in acute ischemic stroke.

Conducted at U.S. and European stroke centers, the study included patients with occlusions in the ICA, M1, M2 and basilar, or vertebral arteries. The Millipede System includes the Millipede⁸⁸ aspiration catheter, Perfuze’s flagship Superbore aspiration catheter.

The MARRS trial enrolled 180 evaluable subjects, with first pass direct aspiration being performed with the Millipede⁸⁸ in 101 patients. The preliminary analysis shows a high rate of First Pass Effect (FPE), defined as complete or near-complete revascularization (mTICI 2c) following a single device pass. For patients treated with Millipede⁸⁸, a 61% FPE rate occurred across all target vessels in the Per Protocol (PP) population. Specifically, for M1 artery occlusions treated with Millipede⁸⁸ in the PP population, a 77% FPE rate was achieved.

“The MARRS data are truly exceptional. Achieving 77% First Pass Effect for M1 occlusions in a pivotal study is a major advance for stroke care. The ability to reliably achieve rapid, complete reperfusion with a single aspiration pass is exactly what we need to improve efficacy. This technology is a powerful tool that simplifies thrombectomy and delivers outstanding performance,” said Dr. Raul G. Nogueira, principal investigator of the MARRS Study and professor of Neurology and Neurosurgery at the University of Pittsburgh School of Medicine.

Across the 180 patients enrolled, delivery success of the Millipede System was 99%, and the median number of passes was one. Preliminary safety analysis showed a 1.7% symptomatic intracranial hemorrhage (sICH) rate. Perforation was reported at 0% and the rate of intracranial dissection was 1.1%, indicating a promising safety profile.

“The MARRS study represents several years of work by the Perfuze team and our clinical partners,” Perfuze Co-Founder/CEO Wayne Allen stated. “We designed the Millipede⁸⁸ to navigate seamlessly to the clot face, enabling a superbore catheter that improves the likelihood of achieving First Pass Effect. This early data reflects that intent, and we’re encouraged by the physician feedback we’ve received to date.”

The MARRS trial completed enrollment earlier this year, executed ahead of schedule, reflecting strong engagement from stroke centers and interest in next-generation aspiration technology. These clinical results follow several successful milestones for Perfuze, including U.S. Food and Drug Administration (FDA) 510(k) clearance for its Zipline Access Catheters and a €22 million funding round to support commercial expansion and operational scale-up.

With these preliminary MARRS data, Perfuze is preparing for FDA submission. “This is a significant inflection point for the company,” Perfuze Chairperson Hooman Hakami commented. “Preliminary MARRS results support the Millipede⁸⁸ catheter’s safety and effectiveness and underpin our vision to advance stroke intervention.”

Millipede⁸⁸ is a superbore aspiration catheter developed to support effective clot retrieval while maintaining navigability through challenging cerebrovascular anatomy. The device is limited by U.S. law to investigational use and is only utilized in Europe for clinical investigation purposes.

Perfuze is a privately held medical device company based in Galway, Ireland. The company is developing advanced catheter technologies that simplify stroke procedures and aim to improve outcomes for patients suffering from acute ischemic stroke.