Perfuze Zipline Access Catheters Cleared by FDA

March 13, 2025—Perfuze, an Ireland-based developer of catheter-based aspiration technology for the treatment of acute ischemic stroke, announced that it has received FDA 510(k) clearance for its Zipline access catheters. In addition, Perfuze has secured €22 million in funding.

The company advised it has initiated a limited market release of Zipline at Comprehensive Stroke Centers in the United States. According to Perfuze, the Zipline access catheters are engineered to enhance the trackability and delivery of large (070) and superbore (088) aspiration catheters.

“The Zipline catheters represent an innovative technology that I believe will simplify stroke intervention, reduce costs, and accelerate reperfusion,” commented Jay Dolia, MD, in the company’s press release. Dr. Dolia, who is Assistant Professor, Neurology, Emory University School of Medicine in Atlanta, Georgia, continued, “In my initial experience, they have enabled rapid clot access and aspiration, even in complex anatomy.”

The company stated that the new investment will be used to support the limited market release of the Zipline and the Millipede catheters as well as to advance its ongoing clinical and research and development initiatives in stroke treatment. The round of €22 million in follow-on funding was led by existing investors including Earlybird, EQT Life Sciences, Seroba, and SV Health, noted the press release.