Millipede⁸⁸ Demonstrates High Revascularization and First Pass Effect Rates in 180 patient multicenter study

Perfuze, a medical device company developing catheter technology for interventional stroke care, today announced positive preliminary results from its pivotal IDE clinical trial, MARRS (Millipede Aspiration for Revascularization in Stroke Study). These preliminary results were presented at the Society for NeuroInterventional Surgery (SNIS) Annual Meeting in Nashville, Tennessee, USA.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250716465479/en/

Millipede88 Aspiration Catheter, Perfuze’s Flagship Superbore Aspiration Catheter

The trial is evaluating the safety and effectiveness of the Millipede System for revascularization in acute ischemic stroke. Conducted across a network of leading stroke centers in the U.S. and Europe, 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 of these 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, an FPE rate of 61% was observed across all target vessels in the Per Protocol (PP) population. Specifically, for M1 artery occlusions treated with Millipede⁸⁸ in the PP population, an FPE rate of 77% 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 1. Preliminary safety analysis showed a symptomatic intracranial hemorrhage (sICH) rate of 1.7%. 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,” said Wayne Allen, CEO and Co-Founder of Perfuze. “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 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,” said Perfuze Chairperson, Hooman Hakami. “Preliminary MARRS results support the Millipede⁸⁸ catheter's safety and effectiveness and underpin our vision to advance stroke intervention.”

About the Millipede System and MARRS Trial

Millipede⁸⁸ is a superbore aspiration catheter developed to support effective clot retrieval while maintaining navigability through challenging cerebrovascular anatomy. The MARRS trial is a prospective, multicenter, single-arm pivotal IDE study designed to evaluate the safety and effectiveness of the Millipede System in patients with large vessel occlusion stroke. Revascularization outcomes were adjudicated by an independent core laboratory.

About Perfuze

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

For more information, visit https://www.perfuze.com. Follow us on LinkedIn and X (formerly Twitter).

Disclaimer:

• United States: CAUTION – Investigational device. Limited by Federal law to investigational use.
• Europe: Exclusively for use in a clinical investigation.
• These are preliminary results from an ongoing clinical investigation. The Clinical Study Report has not yet been approved or reviewed by regulatory authorities. Data may be subject to change and may not fully reflect the contents of the Clinical Study Report.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250716465479/en/

“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," said Dr. Raul G. Nogueira, Principal Investigator of the MARRS Study.