{"id":60924,"date":"2025-03-13T10:02:37","date_gmt":"2025-03-13T09:02:37","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/perfuze-receives-fda-510k-clearance-for-zipline-access-catheters-and-secures-e22m-in-additional-funding\/"},"modified":"2025-03-13T10:02:37","modified_gmt":"2025-03-13T09:02:37","slug":"perfuze-receives-fda-510k-clearance-for-zipline-access-catheters-and-secures-e22m-in-additional-funding","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/perfuze-receives-fda-510k-clearance-for-zipline-access-catheters-and-secures-e22m-in-additional-funding\/","title":{"rendered":"Perfuze Receives FDA 510(k) Clearance for Zipline\u2122 Access Catheters and Secures \u20ac22M in Additional Funding"},"content":{"rendered":"
\n

GALWAY, Ireland–(BUSINESS WIRE)–#CompleteClotIngestion<\/a>–Perfuze, a leading medical device company dedicated to advancing stroke treatment, today announced that it has received FDA 510(k) clearance for its Zipline\u2122 Access Catheters. This regulatory milestone strengthens Perfuze\u2019s growing portfolio of innovative neurovascular devices, empowering physicians to treat acute ischemic strokes with greater speed, ease, and precision. In addition, Perfuze has secured \u20ac22 million in follow-on funding in a round led by existing investors including Earlybird, EQT Life Sciences, Seroba and SV Health.\n<\/p>\n

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\nTransforming Stroke Care with Zipline<\/b>\u2122\n<\/p>\n

\nEvery minute counts in stroke care. As a stroke progresses, human brain tissue is quickly and permanently lost, making urgent therapeutic intervention critical. The Zipline\u2122 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\u2122 aims to optimize clot removal efficiency, ultimately improving procedural success rates and patient outcomes. The FDA clearance marks a significant step forward in Perfuze\u2019s mission to simplify and improve stroke treatment and outcomes through technological innovation.\n<\/p>\n

\n\u201cThe FDA clearance of our Zipline\u2122 Access Catheter is a testament to Perfuze\u2019s commitment to developing best-in-class stroke solutions,\u201d said Wayne Allen, CEO of Perfuze. \u201cThis 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.\u201d Dr. Jay Dolia, Assistant Professor, Neurology, Emory University School of Medicine stated: \u201cThe 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.”\n<\/p>\n

\nFueling Growth: \u20ac22 Million Investment to Drive Commercial Rollout<\/b>\n<\/p>\n

\nPerfuze has successfully closed a \u20ac22 million funding round, led by existing investors. This investment will support the Limited Market Release of the Zipline\u2122 and Millipede\u2122 catheters while advancing ongoing clinical and R&D initiatives to further enhance stroke treatment capabilities.\n<\/p>\n

\nPerfuze has initiated a Limited Market Release in the U.S. in prestigious US Comprehensive Stroke Centres. The company\u2019s growing portfolio is designed to provide physicians with highly effective tools to simplify stroke treatment and improve patient outcomes. \u201cThe continued support from our investors underscores the confidence in Perfuze\u2019s technology and vision,\u201d stated Perfuze Chairperson, Hooman Hakami. \u201cWith 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.\u201d\n<\/p>\n

\nFor more information about Perfuze and its innovative stroke treatment solutions, visit www.perfuze.com<\/a>.\n<\/p>\n

\nAbout Perfuze<\/b>\n<\/p>\n

\nPerfuze 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\u2019s proprietary platform is designed to maximize clot removal efficiency, enhance procedural simplicity, and improve clinical outcomes.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nMedia Contact:<\/b>
Freskida Goni
\n
Communications Consultant Perfuze
\n
freskida.goni@gmail.com<\/a>
+44 7473678178\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

GALWAY, Ireland–(BUSINESS WIRE)–#CompleteClotIngestion–Perfuze, a leading medical device company dedicated to advancing stroke treatment, today announced that it has received FDA 510(k) clearance for its Zipline\u2122 Access Catheters. This regulatory milestone strengthens Perfuze\u2019s growing portfolio of innovative neurovascular devices, empowering physicians to treat acute ischemic strokes with greater speed, ease, and precision. In addition, Perfuze has … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-60924","6":"format-standard","7":"category-industry"},"yoast_head":"\nPerfuze Receives FDA 510(k) Clearance for Zipline\u2122 Access Catheters and Secures \u20ac22M in Additional Funding - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/perfuze-receives-fda-510k-clearance-for-zipline-access-catheters-and-secures-e22m-in-additional-funding\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Perfuze Receives FDA 510(k) Clearance for Zipline\u2122 Access Catheters and Secures \u20ac22M in Additional Funding - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"GALWAY, Ireland–(BUSINESS WIRE)–#CompleteClotIngestion–Perfuze, a leading medical device company dedicated to advancing stroke treatment, today announced that it has received FDA 510(k) clearance for its Zipline\u2122 Access Catheters. 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