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June 23, 2021
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Reperfusion catheter for large vessel occlusion stroke nets FDA clearance

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Penumbra announced it received FDA 510(k) clearance for its reperfusion catheter system designed to help clinicians navigate complex distal vessel anatomy in large vessel occlusion acute ischemic stroke.

The new catheter (Red 62), designed for mechanical thrombectomy, incorporates aspiration for the removal of stroke-causing blood clots from the brain.

Approved FDA_Shutterstock
Source: Adobe Stock

Now available in the U.S., the reperfusion catheter is designed for improved trackability to aid clinicians navigating the complex distal vessel anatomy of the brain during the removal of blood clots.

“With the continued success of aspiration thrombectomy, physicians asked us to address navigation in more challenging distal vessels. Red 62 builds on our previous design generations, continuing our efforts to maximize both trackability and aspiration power,” Adam Elsesser, president and CEO of Penumbra, said in the release. “This is the first catheter in the Red series, which will provide physicians with the broadest portfolio of aspiration thrombectomy solutions for stroke management while also focusing on reducing overall health care costs.”