Perfuze has today announced the receipt of US Food and Drug Administration (FDA) 510(k) clearance for its Zipline access catheters—a regulatory milestone that the company claims will strengthen its growing portfolio of innovative neurovascular devices, empowering physicians to treat acute ischaemic stroke with greater speed, ease, and precision.
In addition, Perfuze has secured €22 million in follow-on funding in a round led by existing investors including Earlybird, EQT Life Sciences, Seroba and SV Health. This investment will support the limited market release of the Zipline and Millipede catheters while advancing ongoing clinical and research and development (R&D) initiatives to further enhance stroke treatment capabilities.
The Zipline access catheters are engineered to enhance the trackability and delivery of large (070) and super-bore (088) aspiration catheters, simplifying neurointerventional procedures and enabling faster, more efficient stroke treatment, Perfuze notes in a press release. By providing increased support and navigational ease, Zipline aims to optimise clot removal efficiency, ultimately improving procedural success rates and patient outcomes.
“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, chief executive officer (CEO) of Perfuze. “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.”
“The Zipline catheters represent an innovative technology that I believe will simplify stroke intervention, reduce costs and accelerate reperfusion,” added Jay Dolia (Emory University School of Medicine, Atlanta, USA). “In my initial experience, they have enabled rapid clot access and aspiration, even in complex anatomy.”
“The continued support from our investors underscores the confidence in Perfuze’s technology and vision,” stated Hooman Hakami, Perfuze chairperson, discussing the company’s recently secured financial round. “With this funding, we are well-positioned to initiate our US limited market release and drive adoption in select centres of our transformative stroke treatment solutions.”
