Penumbra's THUNDERBOLT Receives FDA Clearance - Bringing Computer Assisted Vacuum Thrombectomy Technology to Stroke

Penumbra’s FDA nod for clot removal tech a win for Boston Scientific

The stroke treatment could contribute about $100 million in incremental revenue over time to Boston Scientific, the buyer of Penumbra, one analyst said.

Penumbra's THUNDERBOLT Receives FDA Clearance - Bringing Computer Assisted Vacuum Thrombectomy Technology to Stroke

THUNDERBOLT is the first CAVT platform to deliver modulated aspiration for acute ischemic stroke — enabling faster, more complete clot removal

Boston Scientific’s Penumbra Deal Gains Weight With Thunderbolt Stroke Clearance

Penumbra, which Boston Scientific (NYSE:BSX) agreed to acquire in early 2026, has received FDA clearance for its Thunderbolt computer assisted vacuum thrombectomy device. Thunderbolt is designed for stroke treatment, broadening Penumbra's neurovascular offering as the acquisition process moves toward completion. This clearance adds another stroke intervention device that could be part of Boston Scientific's portfolio once the transaction closes.…

FDA clears new computer-assisted device for removing clots in stroke patients

The Thunderbolt device from California-based Penumbra uses modulated aspiration to detect and remove blood clots. Back in January, Boston Scientific agreed to acquire Penumbra for approximately $14.5 billion.

Penumbra’s THUNDERBOLT Receives FDA Clearance – Bringing Computer Assisted Vacuum Thrombectomy Technology to Stroke – Ortho Spine News

THUNDERBOLT is the first CAVT platform to deliver modulated aspiration for acute ischemic stroke — enabling faster, more complete clot removal ALAMEDA, Calif., June 11, 2026 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN), the world’s leading thrombectomy company, announced it has received U.S. Food and Drug Administration (FDA) clearance for THUNDERBOLT, expanding its computer assisted vacuum thrombectomy (CAVT) technology to address acute ischemic stroke. “Stroke is the second leading cause of death worldwide and with stroke, timing is critical. If the blood clot isn’t removed and the artery reopened quickly, patients can face severe disability or even death,” said Donald Frei, M.D., neurointerventional radiologist at Swedish Medical Center, Denver, CO. “What sets THUNDERBOLT apart is the innovative design which minimizes catheter manipulation and promotes safe, complete clot capture – quickly restoring blood flow to the brain and giving patients the best chance at recovery.” 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. “Modulated aspiration may facilitate more consistent and complete clot removal when used in conjunction with standard aspiration thrombectomy catheters,” said David Fiorella, MD, PhD, director of the Cerebrovascular Center at Stony Brook University Hospital. “Our early experience with THUNDERBOLT within the context of the trial, suggests that this technology will meaningfully change how we approach stroke treatment, and could substantively improve outcomes in patients with emergent large vessel occlusion.” A recent analysis estimates that stroke mortality worldwide is projected to increase by 50% between 2020 to 2050.i In the U.S., someone suffers from a stroke every 40 seconds, and 1 in every 21 people dies from the condition.ii  As the only CAVT device available for stroke treatment in the U.S., THUNDERBOLT represents a first-of-its-kind advancement in acute ischemic stroke care. “Penumbra was founded to redefine stroke care and THUNDERBOLT delivers on that promise,” said Shruthi Narayan, president of Penumbra. “We are uniquely positioned as the only company offering CAVT technology across both vascular and neurovascular conditions — redefining blood clot care from head-to-toe. Penumbra has delivered more than two decades of innovation, and THUNDERBOLT marks the beginning of a new era in stroke management, one that we believe will fundamentally change outcomes for patients.” 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 PenumbraPenumbra, 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 InformationAdditional information about Penumbra’s products can be located on Penumbra’s website at https://www.penumbrainc.com/providers. Caution: Federal (USA) law restrictions these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use 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 StatementsExcept 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. ContactJennifer HethParinaz Farzin Penumbra, IncMerryman Communicationsjheth@penumbrainc.comparinaz@merrymancommunications.com510-995-9791310.600.6746 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/fulltextii “2024 Heart Disease and Stroke Statistics Update Fact Sheet”. American Heart Association. Accessed on November 13, 2025. https://www.heart.org/-/media/PHD-Files-2/Science-News/2/2024-Heart-and-Stroke-Stat-Update/2024-Statistics-At-A-Glance-final_2024.pdf SOURCE Penumbra, Inc.

Penumbra’s Thunderbolt CAVT Platform Cleared by FDA for Stroke Treatment

June 11, 2026—Penumbra, Inc. announced it has received FDA clearance for the Thunderbolt computer-assisted vacuum thrombectomy (CAVT) platform for the treatment of acute ischemic stroke. Powered by the Penumbra Engine, Thunderbolt introduces modulated aspiration to the company’s neuro thrombectomy portfolio, offering CAVT technology to detect, fatigue, and completely ingest clot at the site of the occlusion, stated Penumbra. Thunderbolt will be …