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Perfuze wins FDA nod for access catheter, raises $24M

March 13, 2025 By Sean Whooley

Perfuze Zipline Access Catheter
The Zipline access catheter. [Image courtesy of Perfuze]
Perfuze announced today that it received FDA 510(k) clearance for its Zipline access catheter and secured significant funding.

The Galway, Ireland–based medtech company picked up about $24 million (€22 million) in a follow-on funding round. Existing investors, including Earlybird, EQT Life Sciences, Seroba and SV Health, participated in the round. The company earmarked funds to support the commercial rollout of the Zipline and Milipede catheters. Other uses include advancing ongoing clinical and R&D initiatives to further enhance stroke treatment capabilities.

Perfuze’s funding supports its technologies, which include the now-FDA-cleared Zipline access catheters for improving stroke care. Zipline catheters enhance the trackability and delivery of large (070) and superbore (088) aspiration catheters. This simplifies neurointerventional procedures to enable faster, more efficient stroke treatment.

By providing increased support and navigational ease, Zipline aims to optimize clot removal efficiency. Perfuze says this can improve procedural success rates and patient outcomes. The company says FDA clearance marks “a significant step” in its mission to simplify and improve stroke treatment and outcomes.

Perfuze said it initiated a limited market release in the U.S. for its catheters in prestigious U.S. stroke centers.

“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,” said Wayne Allen, CEO of Perfuze.

Perfuze chair Hooman Hakami says the continued support from investors “underscores the confidenze” in the company’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,” Hakami said.

Filed Under: 510(k), Applications, Business, Catheters, Neurology, Regulatory, Technologies & Devices Tagged With: Perfuze

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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