FDA clears Perfuze’s Zipline access catheter for stroke treatment

Nowhere do they mention getting to 100% recovery, so I'd have to say this is a failure at that! Aren't you glad your stroke medical world pushes failure rather that delivering recovery? The only goal in stroke is 100% recovery, anyone working on less than that needs to be fired!

 FDA clears Perfuze’s Zipline access catheter for stroke treatment

According to the World Stroke Organization · Medical Device Network

Ross Law

Thu, March 13, 2025 at 11:58 AM CDT 2 min read

The US Food and Drug Administration (FDA) has cleared Perfuze’s Zipline single-use access catheter for acute ischemic stroke (AIS) procedures.

The Irish company’s medical device is used in delivering large-bore catheters using standard endovascular techniques.

During AIS procedures, Zipline is advanced over a guidewire to the desired location in the neurovasculature. An outer catheter is subsequently advanced over the Zipline access catheter to the desired location.

According to Perfuze, the increased support and navigational ease in using Zipline for catheter delivery helps to optimise the efficiency of clot removals, leading to improved procedural success rates and patient outcomes.

Commenting on his experience using Perfuze’s access catheter, Emory University School of Medicine's assistant neurology professor Dr Jay Dolia stated that Zipline had “enabled rapid clot access and aspiration, even in complex anatomy”.

Perfuze CEO Wayne Allen commented: “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.”

Coinciding with the FDA clearance, Perfuze has also closed a €22m ($23.9m) follow-on funding round, bringing its funding to date to around €50m.

Led by existing investors, including EQT Life Sciences; Seroba; and SV Health, Perfuze chairperson Hooman Hakam said the latest funding round would help support the company’s recently initiated limited market release of the Zipline and Millipede catheters to selected stroke centres across the US. The financing will also be used to advance R&D initiatives to further develop the company’s stroke treatment portfolio.

Considered a medical emergency, AIS occurs when blood flow to the brain is blocked – a situation commonly caused by blood clots or plaque buildup in the arteries (atherosclerosis) – leading to potential brain damage and loss of function.

According to experts, while AIS accounts for 85% of all strokes, fewer than 30% of patients receive treatment within the optimal timeframe, highlighting a need for more education around improving AIS symptom recognition. What it signifies is a need for protocols right after the clot buster of bleed stopper that deliver 100% recovery! And you don't understand that simple idea? How much of blithering idiots do stroke survivors have to put up with?

Oops, I'm not playing by the polite rules of Dale Carnegie,  'How to Win Friends and Influence People'. 

Telling your supposedly smart doctor they know nothing about stroke is a no-no even if it is true. 

Politeness will never solve anything in stroke. Yes, I'm a bomb thrower and proud of it. Someday a stroke 'leader' will try to ream me out for making them look bad by being truthful, I look forward to that day.

"FDA clears Perfuze’s Zipline access catheter for stroke treatment" was originally created and published by Medical Device Network, a GlobalData owned brand.