FDA cleared Perfuze's Millipede System on March 16. The traditional 510(k), K253590, covers the Millipede88 aspiration catheter for acute ischemic stroke from internal carotid or M1 occlusions within eight hours of onset. It also covers the Millipede70 catheter and an aspiration tube set. Millipede88 becomes the first 0.088-inch catheter cleared for standalone direct aspiration, with no separate large-bore intermediary. FDA received the file on November 17, 2025; the decision took 119 days.
The predicate was Route 92 Medical's HiPoint Reperfusion System (K243601). The clinical evidence is MARRS, a prospective study at 22 sites in the U.S., France and Spain that enrolled 180 patients. 88.9% achieved mTICI 2b or better reperfusion within three passes without rescue therapy, against a 63.7% performance goal. First-pass effect (mTICI 2c or better) in M1 occlusions was 77%. Symptomatic intracranial hemorrhage at 24 hours was 2.3%, and 52.5% of patients reached mRS 0 to 2 at 90 days.
Perfuze, based in Galway and led by CEO Wayne Allen, raised a €22M follow-on round in March 2025. Earlybird, EQT Life Sciences, Seroba and SV Health took part, bringing total funding to €44.5M. Launch begins with a limited release at select U.S. comprehensive stroke centers. MARRS principal investigator Raul Nogueira of UPMC said the 77% first-pass rate and 96% delivery success were unprecedented in an independently adjudicated thrombectomy trial.
A 119-day traditional 510(k) carrying a 180-patient multinational study is the neurovascular norm now. The predicate got Perfuze the pathway, and the trial got it the indication.