Perfuze, a leading medical device company dedicated to advancing stroke treatment, has received FDA 510(k) clearance for its Zipline Access Catheters. This milestone strengthens Perfuze’s growing portfolio of innovative neurovascular devices, enabling physicians to treat acute ischemic strokes rapidly, easily, and precisely. Plus, 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.
Every minute counts for stroke care. And as a stroke progresses, human brain tissue is quickly and permanently lost, making urgent therapeutic intervention critical.
The Zipline Access Catheters are engineered to enhance the trackability and delivery of large (070) and superbore (088) aspiration catheters, simplifying neurointerventional procedures and enabling faster and more efficient stroke treatment.
And by providing increased support and navigational ease, Zipline aims to optimize clot removal efficiency, improving procedural success rates and patient outcomes. And the FDA clearance marks a major step forward in Perfuze’s mission to simplify and improve stroke treatment and outcomes through technological innovation.
This investment will also support the Limited Market Release of the Zipline and Millipede catheters while advancing ongoing clinical and R&D initiatives to enhance stroke treatment capabilities further.
Perfuze has also initiated a Limited Market Release in the U.S. in prestigious US Comprehensive Stroke Centres. And the company’s growing portfolio is designed to provide physicians with highly effective tools to simplify stroke treatment and improve patient outcomes.
KEY QUOTES:
“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 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.”
- Wayne Allen, CEO of Perfuze
“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.”
- Dr. Jay Dolia, Assistant Professor, Neurology, Emory University School of Medicine
“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.”
- Perfuze Chairperson Hooman Hakami
