Penumbra Expands CAVT for Stroke to Europe with CE Mark for THUNDERBOLT
Rhea-AI Summary
Penumbra (NYSE:PEN) received CE Mark in Europe for its THUNDERBOLT computer assisted vacuum thrombectomy (CAVT) system for acute ischemic stroke, following recent FDA clearance in the U.S.
THUNDERBOLT, powered by the Penumbra ENGINE, introduces modulated aspiration and is described as the only CAVT device available for stroke treatment in Europe and the U.S.
Positive
- CE Mark in Europe for THUNDERBOLT CAVT stroke system
- Recent U.S. FDA clearance supports global THUNDERBOLT rollout
- Only CAVT device available for stroke treatment in Europe and U.S.
- Expansion of Penumbra's neuro thrombectomy portfolio with modulated aspiration
- Pre-packaged THUNDERBOLT kits with multiple RED catheter options
Negative
- None.
News Market Reaction – PEN
In the Jun 15 session, PEN declined 0.16%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 11 | FDA device clearance | Positive | +0.1% | U.S. FDA clearance for THUNDERBOLT CAVT stroke system with modulated aspiration. |
| May 06 | Q1 2026 earnings | Positive | +0.1% | Reported Q1 2026 revenue growth across thrombectomy and embolization & access lines. |
| Apr 13 | Clinical trial data | Positive | +0.5% | STORM-PE trial showed better 90-day outcomes with CAVT plus anticoagulation. |
| Feb 25 | FY 2025 earnings | Positive | -0.3% | Strong Q4 and FY2025 revenue and income metrics with improved gross margin. |
| Feb 04 | Acquirer earnings | Positive | -4.5% | Boston Scientific reported strong Q4 and FY2025 results with raised 2026 guidance. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent company-specific news (FDA clearance, trial data, earnings) has generally seen modest, aligned price reactions, with occasional divergences on earnings-related or acquirer news.
Over the past six months, Penumbra reported strong financial performance, with Q4 2025 revenue of $385.4M and full-year 2025 revenue of $1,403.7M, followed by Q1 2026 revenue of $374.8M. Clinical updates like the STORM-PE trial showed significantly better functional outcomes with CAVT. Regulatory progress included recent U.S. FDA clearance for THUNDERBOLT on Jun 11, 2026. The current CE Mark news extends this CAVT stroke platform geographically, building directly on the U.S. clearance and prior CAVT clinical data.
Key Terms
computer assisted vacuum thrombectomy medical
acute ischemic stroke medical
ce mark regulatory
thrombectomy medical
catheters medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
The THUNDERBOLT TM Computer Assisted Vacuum Thrombectomy (CAVTTM) technology introduces modulated aspiration for acute ischemic stroke for the first time, enabling more rapid, complete clot removal
"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,". said Prof. Vincent Costalat, Head of Neuroradiology at Centre Hospitalier Universitaire, Montpellier,
Powered by the Penumbra ENGINE™, THUNDERBOLT introduces modulated aspiration to Penumbra's neuro thrombectomy portfolio, offering advanced CAVT technology designed to detect, fatigue, and completely ingest clot at the site of the occlusion.
"THUNDERBOLT is a culmination of two decades of research and innovation at Penumbra," said Shruthi Narayan, president of Penumbra. "By introducing CAVT to the neurovascular field in
A recent analysis estimates that stroke mortality worldwide is projected to increase by
"THUNDERBOLT has the potential to shorten procedure times — improving patient safety, delivering better outcomes and streamlining care for the physicians who treat them," said Joan Kristensen, head of the
THUNDERBOLT will be pre-packaged with one of Penumbra's market-leading catheters - RED™ 62, RED 68, RED 72 SILVER LABEL or RED 72 SILVER LABEL with SENDit™ technology.
About Penumbra
Penumbra, Inc., the world's leading thrombectomy company, is focused on developing the most innovative technologies for challenging medical conditions such as ischemic stroke, venous thromboembolism such as pulmonary embolism, and acute limb ischemia. Our broad portfolio, which includes computer assisted vacuum thrombectomy (CAVT), centers on removing blood clots from head-to-toe with speed, safety and simplicity. By pioneering these innovations, we support healthcare providers, hospitals and clinics in more than 100 countries, working to improve patient outcomes and quality of life. For more information, visit www.penumbrainc.com and connect on Instagram, LinkedIn and X.
Important Safety Information
Additional information about Penumbra's products can be located on Penumbra's website at https://www.penumbrainc.com/providers. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use (IFU) for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Please visit www.peninc.info/risk for the complete IFU Summary Statements. The clinical results presented herein are for informational purposes only and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.
Forward-Looking Statements
Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: the risk that the pending acquisition by Boston Scientific Corporation will not be completed in the expected timeframe or at all, including the risk that required regulatory approvals will not be obtained; potential adverse effects to our business during the pendency of the acquisition, such as employee departures or diversion of management's attention from our business; failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory or other assets; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; potential adverse regulatory actions; and the potential impact of any acquisitions, mergers, dispositions, joint ventures or investments we may make. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2025, which we filed on February 25, 2026. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.
Contact
Jennifer Heth
Penumbra, Inc.
jheth@penumbrainc.com
510-995-9791
Parinaz Farzin
Merryman Communications
parinaz@merrymancommunications.com
310.600.6746
i "Pragmatic solutions to reduce the global burden of stroke: a World Stroke Organization–Lancet Neurology Commission". The Lancet. Accessed on November 13, 2025. https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(23)00277-6/fulltext
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SOURCE Penumbra, Inc.