Penumbra's CAVT Technology Receives FDA Clearance for the Treatment of Deep Vein Thrombosis (DVT)
BOLT-DVT reported complete or near-complete clot removal in 98% of patients, alongside improvements in pain and quality of life.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Penumbra (PEN) received FDA clearance for its Lightning computer assisted vacuum thrombectomy technology to treat deep vein thrombosis, or DVT. The clearance is supported by BOLT-DVT, a prospective, multicenter trial enrolling patients with iliofemoral DVT. The technology removes blood clots using suction.
Complete or near-complete clot removal occurred in 98% of patients, with a median device time of 18 minutes. The 48-hour major adverse event rate was 3.1%; no device-related deaths or serious device-related adverse events were observed. Re-thrombosis occurred in 3.9% within 30 days. At 30 days, treated-vessel patency, meaning vessels remaining open, ranged from 88.8% to 96.3%, and 84.3% of patients had no post-thrombotic syndrome symptoms. Median leg pain fell from 5 at baseline to 0 immediately after treatment and at 30 days. Median VEINES-QOL quality-of-life scores improved from 49.3 to 84.2 at 30 days.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Major pointLightning technology received FDA clearance to treat deep vein thrombosis.
- Minor pointBOLT-DVT achieved 98% complete or near-complete clot removal, with median device time of 18 minutes.
- Minor pointBOLT-DVT observed no device-related deaths or serious device-related adverse events.
- Minor pointTreated vessels had 88.8%-96.3% patency rates at 30 days.
- Minor pointPatients with no post-thrombotic syndrome symptoms represented 84.3% at 30 days, using Villalta scores of 0-4.
2 minor points
- Minor pointMedian leg pain decreased from 5 at baseline to 0 immediately post-procedure and at 30 days.
- Minor pointMedian VEINES-QOL quality-of-life scores improved from 49.3 to 84.2 at 30 days.
Negative
- Minor pointBOLT-DVT recorded a 3.1% major adverse event rate within 48 hours.
- Minor pointRe-thrombosis occurred in 3.9% of patients within 30 days.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
"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
In the
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
jheth@penumbrainc.com
510-995-9791
Parinaz Farzin
M+
parinaz@mplushealth.com
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
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SOURCE Penumbra, Inc.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did the FDA clear Penumbra's Lightning technology to treat?
The FDA cleared Penumbra's Lightning computer assisted vacuum thrombectomy technology for the treatment of deep vein thrombosis, or DVT. The clearance is supported by BOLT-DVT, a prospective, multicenter trial enrolling patients with iliofemoral DVT.
What were the clot-removal and safety results in Penumbra's BOLT-DVT trial?
BOLT-DVT reported 98% complete or near-complete clot removal and a 3.1% major adverse event rate within 48 hours. Median device time was 18 minutes. No device-related deaths or serious device-related adverse events were observed, and re-thrombosis occurred in 3.9% within 30 days.