BOLT-DVT, a recent prospective, multicenter Investigational Device Exemption (IDE) trial, demonstrated first-line use of computer assisted vacuum thrombectomy (CAVT) for DVT is safe and effective

ALAMEDA, Calif., Oct. 20, 2026 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), the world's leading thrombectomy company, announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the treatment of deep vein thrombosis (DVT) to the company's Lightning™ computer assisted vacuum thrombectomy (CAVT™) technology. This indication is supported by positive results from the BOLT-DVT Investigational Device Exemption (IDE) trial, which demonstrated the safety and efficacy of CAVT in treating DVT.

"The standard treatment for DVT has been anticoagulation and there has not been a meaningful change in standard of care for decades," said Patrick Muck, M.D., RVT, FACS, co-principal investigator of BOLT-DVT and vascular surgeon at TriHealth in Cincinnati, Ohio. "Anticoagulation primarily prevents clot progression and does little to remove the existing clot. The BOLT-DVT trial showed that CAVT delivered rapid clot removal, durable patient-reported pain relief and a low rate of re-thrombosis. The data resulted in the first cleared indication for the treatment of DVT amongst mechanical thrombectomy devices, underscoring the potential of CAVT to advance the treatment algorithm of DVT and improve patient outcomes."

In the U.S., an estimated 900,000 cases of venous thromboembolism, which includes DVT and pulmonary embolism (PE), occur annually.^[i] DVT can be a serious health condition because blood clots in the veins can break loose and travel through the bloodstream, potentially causing a PE, which can be a life-threatening medical emergency. BOLT-DVT enrolled patients with iliofemoral DVT, building on the historical precedent set by the ATTRACT randomized controlled trial but with modern technology. In BOLT-DVT, 98% of patients experienced complete or near-complete thrombus removal with a median device time of just 18 minutes and a low 48-hour major adverse event rate of 3.1%. These strong procedural outcomes were accompanied by a low re-thrombosis rate and improvements in patient-reported and clinician-assessed outcomes, including reduced pain and symptoms, and improved quality of life.

In the BOLT-DVT trial, treatment with CAVT successfully restored lower extremity deep venous flow in a single session," said Kush R. Desai, M.D., FSIR, co-principal investigator of BOLT-DVT and interventional radiologist at Northwestern Medicine. "Perhaps more significant, patients felt immediate pain relief and by 30 days, there was significant improvement in venous stasis symptoms that included lower extremity pain and swelling. These findings provide clinicians with important evidence supporting the benefits of advanced intervention, such as CAVT, as a first-line treatment for acute iliofemoral DVT."

Additional findings from the trial included:

• No device-related deaths or serious device-related adverse events were observed
• Low re-thrombosis rate of 3.9% within 30 days
• High 30-day patency rates of 88.8%-96.3% across treated vessels
• 84.3% of patients with no PTS symptoms (Villalta 0-4, no PTS) at 30 days
• Median leg pain severity decreased from 5 (moderate to severe) at baseline to 0 (no pain) immediately post-procedure and 0 (no pain) at 30 days
• Significant improvements in patient-reported overall quality of life at 30 days, with median VEINES-QOL scores improving from 49.3 to 84.2

"DVT remains an underestimated health issue that can lead to serious, potentially life-threatening complications," said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. "This cleared treatment indication and the BOLT-DVT findings support advanced intervention for DVT and highlight the potential impact of CAVT on patient symptoms, quality of life and long-term clinical outcomes."

Penumbra's CAVT portfolio incorporates Lightning Flash™ technology, which utilizes pressure- and flow-based aspiration control algorithms during thrombectomy procedures to detect blood clot and blood flow. The portfolio is designed to facilitate clot removal with speed, safety and simplicity, allowing physicians to better navigate the body's complex anatomy and deliver high power aspiration for clot removal.

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, deep vein thrombosis 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 Risk 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
[email protected]
510-995-9791

Parinaz Farzin
M+
[email protected]
310.600.6746

^[i] "Learn about Pulmonary Embolism," American Lung Association. Accessed on Oct. 7, 2025. https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism

View original content to download multimedia:https://www.prnewswire.com/news-releases/penumbras-cavt-technology-receives-fda-clearance-for-the-treatment-of-deep-vein-thrombosis-dvt-302913869.html

SOURCE Penumbra, Inc.