Perfuze Receives FDA 510(k) Clearance for Zipline™ Access Catheters and Secures €22M in Additional Funding

GALWAY, Ireland--(BUSINESS WIRE)--Mar 13, 2025--

Perfuze, a leading medical device company dedicated to advancing stroke treatment, today announced that it has received FDA 510(k) clearance for its Zipline™ Access Catheters. This regulatory milestone strengthens Perfuze’s growing portfolio of innovative neurovascular devices, empowering physicians to treat acute ischemic strokes 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.

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Transforming Stroke Care with Zipline ™

Every minute counts in stroke care. 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, more efficient stroke treatment. By providing increased support and navigational ease, Zipline™ aims to optimize clot removal efficiency, ultimately improving procedural success rates and patient outcomes. The FDA clearance marks a significant step forward in Perfuze’s mission to simplify and improve stroke treatment and outcomes through technological innovation.

“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.” Dr. Jay Dolia, Assistant Professor, Neurology, Emory University School of Medicine stated: “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."

Fueling Growth: €22 Million Investment to Drive Commercial Rollout

Perfuze has successfully closed a €22 million funding round, led by existing investors. This investment will support the Limited Market Release of the Zipline™ and Millipede™ catheters while advancing ongoing clinical and R&D initiatives to further enhance stroke treatment capabilities.

Perfuze has initiated a Limited Market Release in the U.S. in prestigious US Comprehensive Stroke Centres. The company’s growing portfolio is designed to provide physicians with highly effective tools to simplify stroke treatment and improve patient outcomes. “The continued support from our investors underscores the confidence in Perfuze’s technology and vision,” stated Perfuze Chairperson, Hooman Hakami. “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.”

For more information about Perfuze and its innovative stroke treatment solutions, visit www.perfuze.com.

About Perfuze

Perfuze is a medical device company headquartered in Galway, Ireland, dedicated to developing next-generation catheter-based aspiration technology for the treatment of acute ischemic stroke. The company’s proprietary platform is designed to maximize clot removal efficiency, enhance procedural simplicity, and improve clinical outcomes.

Zipline Access Catheter (with coil) delivering the Millipede 088 catheter (Photo: Business Wire)

PARIS (AP) — A Paris court is to rule on Monday in a case involving 10 people accused of cyberbullying French first lady Brigitte Macron by spreading false online claims about her gender and sexuality, allegations her daughter said damaged her health and family life.

The defendants, eight men and two women aged 41 to 60, are accused of posting “numerous malicious comments” falsely claiming that President Emmanuel Macron ’s wife was born a man and linking the 24-year age gap with her husband to pedophilia. Some of the posts were viewed tens of thousands of times.

Brigitte Macron did not attend the two-day trial in October.

Her daughter, Tiphaine Auzière, testified about what she described as the “deterioration” of her mother’s life since the online harassment intensified. “She cannot ignore the horrible things said about her,” Auzière told the court. She said the impact has extended to the entire family, including Macron’s grandchildren.

Defendant Delphine Jegousse, 51, who is known as Amandine Roy and describes herself as a medium and an author, is considered as having played a major role in spreading the rumor after she released a four-hour video on her YouTube channel in 2021.

The X account of Aurélien Poirson-Atlan, 41, known as Zoé Sagan on social media, was suspended in 2024 after his name was cited in several judicial investigations.

Other defendants include an elected official, a teacher and a computer scientist. Several told the court their comments were intended as humor or satire and said they did not understand why they were being prosecuted. They face up to two years in prison if convicted.

The case follows years of conspiracy theories falsely alleging that Brigitte Macron was born under the name Jean-Michel Trogneux, which is actually the name of her brother. The Macrons have also filed a defamation suit in the United States against conservative influencer Candace Owens.

The Macrons, who have been married since 2007, first met at the high school where he was a student and she was a teacher. Brigitte Macron, 24 years her husband’s senior, was then called Brigitte Auzière, a married mother of three.

Emmanuel Macron, 48, has been France’s president since 2017.

FILE - French President's wife Brigitte Macron arrives ahead of the ceremony outside "La Belle Equipe" bar, Thursday Nov. 13, 2025 in Paris as part of ceremonies marking the 10th anniversary of terrorist attacks. (Ludovic Marin, Pool photo via AP, File)