Perfuze, an Ireland-based medical device company focused on stroke treatment, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Zipline Access Catheters, allowing it to expand its neurovascular technology portfolio.
The regulatory approval supports the company’s goal of providing advanced catheter solutions to enhance the efficiency of acute ischemic stroke procedures.
In conjunction with the clearance, Perfuze has raised €22m in additional funding, with continued backing from Earlybird, EQT Life Sciences, SV Health, and Seroba.
The investment will be used to introduce the Zipline and Millipede catheters to the US market through a limited market release. The proceeds will also support ongoing research and development efforts aimed at further improving stroke intervention technologies.
The Zipline Access Catheters are designed to improve the navigation and support of aspiration catheters, helping clinicians conduct neurointerventional procedures with greater precision.
According to Perfuze, the technology enables enhanced movement and stability, allowing for more efficient clot removal.
Following regulatory clearance, Perfuze has commenced a limited market release in selected comprehensive stroke centres across the US, where its technology will be used in clinical settings.
Perfuze CEO Wayne Allen said: “The FDA clearance of our Zipline Access Catheter is a testament to Perfuze’s commitment to developing best-in-class stroke solutions.
“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.”
Perfuze develops aspiration catheter technologies intended to streamline stroke procedures and improve patient outcomes. With its latest funding secured, the company plans to advance research and accelerate product innovation as it strengthens its presence in the neurovascular treatment sector.
