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Penumbra earns CE mark for Thunderbolt thrombectomy system

June 15, 2026 By Sean Whooley

Penumbra Thunderbolt computer-assisted vacuum thrombectomy technology
The Thunderbolt computer-assisted vacuum thrombectomy system [Image courtesy of Penumbra]
Penumbra (NYSE:PEN) announced today that it received CE mark approval for its Thunderbolt thrombectomy system for stroke.

European approval for the computer-assisted vacuum thrombectomy (CAVT) technology comes just days after FDA clearance.

Thunderbolt expands the company’s computer-assisted vacuum thrombectomy (CAVT) portfolio. It aims to address acute ischemic stroke through the use of modulated aspiration. The system offers advanced CAVT technology designed to detect, fatigue and completely ingest clot at the site of the occlusion.

Alameda, California-based Penumbra powers Thunderbolt, a first-of-its-kind advancement in acute ischemic stroke, with its Engine platform. It marks the first and only CAVT device available in the U.S. and now Europe for stroke treatment.

Thunderbolt will come pre-packaged with one of Penumbra’s catheters, including Red 62, Red 68, Red 72, Silver Label or Red 72 Silver Label with SENDit technology.

(Penumbra is also subject to a planned $14.5 billion acquisition by Boston Scientific. Read more about that here.)

Commentary from Penumbra officials

Shruthi Narayan, president of Penumbra, said:

“Thunderbolt is a culmination of two decades of research and innovation at Penumbra. By introducing CAVT to the neurovascular field in Europe, we are ushering in a new era of stroke management that will have a significant impact on patient care. We are the only company to offer CAVT technology across both vascular and neurovascular care as we are committed to transforming how life-threatening clots are treated from head-to-toe worldwide.”

Joan Kristensen, head of EMEA for Penumbra, said:

“Thunderbolt has the potential to shorten procedure times — improving patient safety, delivering better outcomes and streamlining care for the physicians who treat them. Bringing this technology to Europe is a significant milestone — and a reflection of Penumbra’s ongoing commitment to putting the most advanced stroke care tools in the hands of physicians across the region.”

Filed Under: Applications, Catheters, CE Mark, Neurology, Regulatory, Technologies & Devices Tagged With: penumbra

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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