Perfuze publishes final MARRS results showing strong stroke reperfusion

Perfuze, a Galway, Ireland-based medical device company, has published final results from its MARRS pivotal trial in the Journal of Neurointerventional Surgery. The study evaluated the company's Millipede Aspiration System in 180 patients with acute ischemic stroke across 22 US and European hospitals, under a US FDA Investigational Device Exemption, with all imaging and safety endpoints independently adjudicated.

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The trial met its primary endpoint, achieving successful reperfusion (mTICI 2b-3) in 89% of patients without rescue therapy, exceeding its prespecified performance goal. Standalone direct aspiration with the super-bore Millipede88 catheter delivered a 75% first-pass effect in middle cerebral artery M1 occlusions, with rescue therapy required in under 8% of Millipede88 cases and 96% delivery success. Safety data showed a 2.3% symptomatic intracranial hemorrhage rate, no vessel perforations, and no device-related serious adverse events. The data previously supported FDA 510(k) clearance of the Millipede88 Aspiration Catheter.

For Perfuze, the results validate the design of its Corrugated catheter architecture, which the company says preserves inner lumen integrity to maintain aspiration force at the clot face, differentiating it from conventional coiled or braided aspiration catheters. MARRS Principal Investigator Dr. Raul Nogueira said the independently adjudicated first-pass and reperfusion rates are "the highest rates reported to date in a prospective thrombectomy study."

For the broader MedTech space, the results land as super-bore aspiration continues to grow as the fastest-expanding segment of the mechanical thrombectomy market, with leading stroke centers increasingly favoring aspiration-first approaches. Perfuze continues a Limited Market Release of the Millipede88 system at select US Comprehensive Stroke Centers, with broader commercialization to follow.