The US Food and Drug Administration (FDA) has cleared Perfuze’s Zipline single-use access catheter for acute ischemic stroke (AIS) procedures.
The Irish company’s medical device is used in delivering large-bore catheters using standard endovascular techniques.
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During AIS procedures, Zipline is advanced over a guidewire to the desired location in the neurovasculature. An outer catheter is subsequently advanced over the Zipline access catheter to the desired location.
According to Perfuze, the increased support and navigational ease in using Zipline for catheter delivery helps to optimise the efficiency of clot removals, leading to improved procedural success rates and patient outcomes.
Commenting on his experience using Perfuze’s access catheter, Emory University School of Medicine’s assistant neurology professor Dr Jay Dolia stated that Zipline had “enabled rapid clot access and aspiration, even in complex anatomy”.
Perfuze CEO Wayne Allen commented: “This regulatory approval strengthens our growing presence in the US market and supports our vision of delivering novel, effective, and easy-to-use technologies that can make a real difference in stroke care.”
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By GlobalDataCoinciding with the FDA clearance, Perfuze has also closed a €22m ($23.9m) follow-on funding round, bringing its funding to date to around €50m.
Led by existing investors, including EQT Life Sciences; Seroba; and SV Health, Perfuze chairperson Hooman Hakam said the latest funding round would help support the company’s recently initiated limited market release of the Zipline and Millipede catheters to selected stroke centres across the US. The financing will also be used to advance R&D initiatives to further develop the company’s stroke treatment portfolio.
Considered a medical emergency, AIS occurs when blood flow to the brain is blocked – a situation commonly caused by blood clots or plaque buildup in the arteries (atherosclerosis) – leading to potential brain damage and loss of function.
According to experts, while AIS accounts for 85% of all strokes, fewer than 30% of patients receive treatment within the optimal timeframe, highlighting a need for more education around improving AIS symptom recognition.
