Perfuze announced that it received FDA 510(k) clearance for its Millipede88 aspiration catheter.
Galway, Ireland-based Perfuze designed the catheter for rapid and complete clot removal in patients suffering from large vessel occlusion (LVO) strokes. The company aims to improve stroke treatment outcomes and reduce procedural complexity.
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Millipede88 features a patented corrugated catheter architecture designed to simplify navigation through the neurovascular anatomy. Its design helps to preserve inner lumen integrity to maintain maximum aspiration force at the face of the clot. Perfuze said it achieves high first-pass reperfusion rates and short procedure times in mechanical thrombectomy.
The company said its clearance follows the successful completion of the MARRS clinical study, which met all primary objectives. Clearance covers standalone direct aspiration, so physicians can achieve reperfusion with Millipede88 alone. The company said this potentially reduces procedural complexity, lowering per-case device costs and saving critical minutes for patients.
Perfuze believes clearance positions it as a leader in the super-bore aspiration segment in the mechanical thrombectomy market. Other stroke occlusion market players include catheter makers Johnson & Johnson MedTech (Cerenovus), Imperative Care, Terumo Neuro and Route 92 Medical. Boston Scientific (through its acquisition of Penumbra) and Medtronic (through its acquisition of Scientia) are also joining the neurovascular space soon.
The clearance also marks the first standalone 088 catheter indicated for direct aspiration, the company said. It builds on the company’s growing portfolio of technologies in the U.S, including the Zipline access catheter family.
“FDA clearance of the Millipede88 aspiration catheter is a defining moment for Perfuze and for the field of stroke intervention,” said Wayne Allen, CEO of Perfuze. “The MARRS study confirms what our team believed throughout development — that the corrugated design enables excellent first-pass reperfusion rates. With no other 0.088 catheter incorporating this technology, we believe Millipede88 will deliver meaningful clinical outcomes in everyday stroke procedures.”
