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June 15, 2026
Penumbra’s Thunderbolt CAVT Platform for Stroke Gains CE Mark Approval
KEY TAKEAWAYS
- Penumbra’s Thunderbolt computer-assisted vacuum thrombectomy platform receives CE Mark approval for the treatment of acute ischemic stroke.
- The platform introduces modulated aspiration technology intended to facilitate clot ingestion and removal during neuro thrombectomy procedures.
- The approval follows FDA clearance announced June 11, expanding regulatory authorization for the device in major global markets.
June 15, 2026—Penumbra, Inc. announced CE Mark approval for the company’s Thunderbolt computer-assisted vacuum thrombectomy (CAVT) platform to treat acute ischemic stroke globally.
On June 11, the company announced FDA clearance of the Thunderbolt to treat stroke.
According to the company, the Thunderbolt is powered by the Penumbra Engine and introduces modulated aspiration to Penumbra’s neuro thrombectomy portfolio to enable more rapid, complete clot removal. Its advanced CAVT technology is designed to detect, fatigue, and completely ingest clot at the site of the occlusion, noted the company.
Penumbra advised that Thunderbolt will be prepackaged with one of the company’s catheters: Red 62, Red 68, Red 72 Silver Label, or Red 72 Silver Label with SendIt technology.
“Stroke is the second leading cause of death worldwide, and if a blood clot is not fully removed, there is an increased risk of serious complications, disability or death,” commented Professor Vincent Costalat, MD, in the Penumbra’s press release.
Prof. Costalat, who is Head of Neuroradiology at Centre Hospitalier Universitaire Montpellier in Montpellier, France, continued, “I am really enthusiastic and eager to see what Thunderbolt will bring for patients. What I love in the system is that it brings intelligence to the vacuum.”
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