Perfuze secures FDA clearance for stroke treatment catheters and €22M funding
Irish medical device company Perfuze has achieved two significant milestones in advancing acute ischemic stroke treatment technology. The firm has received FDA 510(k) clearance for its Zipline™ Access Catheters alongside securing €22 million in follow-on funding to support commercial rollout and ongoing research initiatives.
Enhanced catheter technology addresses critical time factors
The newly cleared Zipline™ Access Catheters represent an important advancement in neurovascular intervention technology. These devices are specifically engineered to enhance the trackability and delivery of large-bore aspiration catheters, addressing the critical time-sensitive nature of stroke treatment.
Each minute during a stroke event results in permanent loss of brain tissue, making rapid intervention essential for patient outcomes. The Zipline system aims to simplify neurointerventional procedures by optimising the delivery of large (070) and superbore (088) aspiration catheters through improved navigational capabilities and enhanced support.
“The Zipline catheters represent an innovative technology that I believe will simplify stroke intervention, reduce costs and accelerate reperfusion. In my initial experience, they have enabled rapid clot access and aspiration, even in complex anatomy,” stated Dr Jay Dolia, Assistant Professor of Neurology at Emory University School of Medicine.
Investment supports limited market release
The €22 million funding round, led by existing investors including Earlybird, EQT Life Sciences, Seroba and SV Health, will facilitate the Limited Market Release of both the Zipline™ and Millipede™ catheters in prestigious US Comprehensive Stroke Centres.
“The FDA clearance of our Zipline Access Catheter is a testament to Perfuze’s commitment to developing best-in-class stroke solutions,” said Wayne Allen, CEO of Perfuze. “This regulatory approval strengthens our growing presence in the U.S. market and supports our vision of delivering novel, effective, and easy-to-use technologies that can make a real difference in stroke care.”
Technical design focuses on procedural efficiency
The technical design philosophy behind the Zipline system centres on maximising clot removal efficiency whilst simultaneously enhancing procedural simplicity. By providing increased support and improved navigation capabilities, the catheters are engineered to optimise the mechanical thrombectomy process.
Perfuze Chairperson Hooman Hakami noted: “The continued support from our investors underscores the confidence in Perfuze’s technology and vision. With this funding, we are well-positioned to initiate our U.S. Limited Market Release and drive adoption in select centers of our transformative stroke treatment solutions.”
The company’s growing portfolio of neurovascular devices aims to empower physicians with technologies that can improve both procedural success rates and patient outcomes in acute ischemic stroke cases.
- For more information, visit: perfuze.com
