Perfuze has announced the publication of the final results of the MARRS pivotal study in the Journal of NeuroInterventional Surgery (JNIS). The trial met its primary endpoint, with successful reperfusion (modified thrombolysis in cerebral infarction [mTICI] 2b–3) achieved in 89% of patients without rescue therapy—exceeding the prespecified performance goal. The study also demonstrated a 75% rate of first-pass effect mTICI 2c–3 reperfusion in middle cerebral artery (MCA) M1 occlusions and 96% delivery success using the company’s Millipede88 aspiration system.
MARRS was a prospective, multicentre, single-arm pivotal study evaluating the Millipede aspiration system in 180 patients across 22 hospitals in the USA and Europe. It was conducted under a US Food and Drug Administration (FDA) investigational device exemption (IDE) with all imaging and safety endpoints independently adjudicated. The data supported the US FDA 510(k) clearance of the Millipede88 aspiration catheter, which was announced earlier this year.
The results—as stated in a Perfuze press release—support standalone direct aspiration with a super-bore 0.088-inch catheter powered by patented Corrugated technology. Direct aspiration with Millipede88 succeeded without the need for adjunctive devices like stent retrievers in the large majority of cases, with rescue therapy required in fewer than 8% of Millipede88 cases. The study also demonstrated a favourable safety profile, with a 2.3% symptomatic intracranial haemorrhage rate, no vessel perforations, and no device-related serious adverse events.
“In large vessel occlusion [LVO] stroke, the first pass is where outcomes are decided,” said Raul Nogueira (University of Pittsburgh Medical Center, Pittsburgh, USA), a principal investigator of MARRS. “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, Perfuze claims.
“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,” commented Perfuze chief executive officer (CEO) Wayne Allen. “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.”
Perfuze notes that it is continuing its limited market release of the Millipede88 aspiration system in select US comprehensive stroke centres, with broader commercialisation to follow.
