Perfuze Millipede88 restores blood flow 89%

Perfuze said on August 31 that final results from its MARRS pivotal stroke trial showed its Millipede88 aspiration catheter achieved successful reperfusion in 89% of patients without rescue therapy. The Galway, Ireland-based company said the data were published in the *Journal of NeuroInterventional Surgery* and supported the device’s use for direct aspiration in mechanical thrombectomy. The study evaluated patients with acute ischemic stroke caused by large vessel occlusion, a medical emergency in which blood flow to the brain is blocked. Perfuze said the trial met its primary endpoint and exceeded a prespecified performance goal. ### What exactly was measured in the 89% result? The 89% figure refers to successful reperfusion rated as mTICI 2b-3, a standard angiographic measure of restored blood flow after clot removal in stroke procedures. In the MARRS trial, that result was achieved without rescue therapy, meaning operators did not need to switch to additional devices or techniques in those cases. Perfuze said all imaging and safety endpoints were independently adjudicated. (biospace.com) The *Journal of NeuroInterventional Surgery* article described MARRS as a prospective, multicenter, single-arm pivotal study of the Millipede catheter system in patients aged 18 to 85 with internal carotid artery, M1, M2 or basilar artery occlusions. ClinicalTrials.gov lists the study as NCT05714501. ### How large was the study and where was it run? MARRS enrolled 180 patients across 22 hospitals in the United States and Europe, according to Perfuze’s announcement of the final results. (biospace.com) The company said the study was conducted under a U.S. Food and Drug Administration investigational device exemption. The trial was prospective and multicenter, but it did not include a randomized comparison arm against another thrombectomy approach. (jnis.bmj.com) ClinicalTrials.gov and the study protocol describe the investigation as open-label and single-arm, with the goal of assessing both performance and safety of the Millipede system in acute ischemic stroke due to large vessel occlusion. ### What other numbers did Perfuze highlight? Perfuze said the study showed a 75% first-pass effect at mTICI 2c-3 in middle cerebral artery M1 occlusions and 96% delivery success using Millipede88. (finance.yahoo.com) The company also said rescue therapy was required in fewer than 8% of Millipede88 cases. (cdn.clinicaltrials.gov) Raul G. Nogueira, a principal investigator for MARRS at the University of Pittsburgh Medical Center, said in the company announcement that the first-pass effect and successful reperfusion rates were “the highest rates reported to date in a prospective thrombectomy study.” That comparison was made by Nogueira in the press release and not independently assessed here. (neuronewsinternational.com) ### What did the study report on safety? Perfuze said the trial showed a 2.3% symptomatic intracranial hemorrhage rate, no vessel perforations and no device-related serious adverse events. The *JNIS* paper reported safety and efficacy outcomes were independently reviewed, which is a key feature for a pivotal device study. (finance.yahoo.com) The company said the catheter uses a 0.088-inch “super-bore” design and a corrugated architecture intended to preserve lumen integrity and aspiration force at the clot face. That design description comes from Perfuze and related trade coverage of the device. ### Where does this leave the device commercially and clinically? (finance.yahoo.com) Perfuze said in March that Millipede88 had received FDA 510(k) clearance for direct aspiration in mechanical neurovascular thrombectomy. Endovascular Today reported at the time that the company planned a limited U.S. market release in select comprehensive stroke centers, with broader commercialization to follow. (neuronewsinternational.com) The next public milestone is likely broader clinical uptake and post-clearance use at U.S. stroke centers. The final MARRS paper is now available through *JNIS*, and the registered study record remains posted under NCT05714501. (jnis.bmj.com) (evtoday.com)