ALAMEDA, Calif., Oct. 27, 2025 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN) announced the results of the landmark STORM-PE randomized controlled trial (RCT), which found that the use of mechanical thrombectomy, specifically computer assisted vacuum thrombectomy (CAVT™), with anticoagulation achieved superior reduction in right heart strain compared to anticoagulation therapy alone in patients with acute intermediate-high risk pulmonary embolism (PE). The data was presented at a late-breaking session during Transcatheter Cardiovascular Therapeutics^® (TCT^®), the annual scientific symposium of the Cardiovascular Research Foundation^® (CRF^®).

"These findings mark a pivotal step in advancing care for PE, providing the strongest evidence to date that advanced therapy with CAVT can rapidly and safely improve recovery of the right heart compared to conventional anticoagulation therapy," said Robert Lookstein, MD, MSc; co-global principal investigator of the STORM-PE RCT and professor of radiology and surgery at Icahn School of Medicine at Mount Sinai. "STORM-PE supports the role of CAVT as a more effective therapeutic option for intermediate-high risk patients and will evolve the paradigm of care by delivering rapid relief with a comparable safety profile to anticoagulation alone."

The trial enrolled 100 patients across 22 international sites. Patients treated with CAVT demonstrated a greater reduction in right-to-left ventricular (RV/LV) diameter ratio within 48 hours (mean reduction 0.52 vs. 0.24; P<0.001) and nearly 80% of patients had positive treatment effect with CAVT which was significantly greater than the patients who received anticoagulation alone (78.3% vs. 51.9%; P =0.011), reflecting rapid hemodynamic recovery.

"What's particularly compelling is that a significantly greater portion of patients treated with CAVT achieved normalization of RV/LV ratio within 48 hours — a critical indicator of right heart recovery — without an increase in complications," said Rachel Rosovsky, MD, MPH, co-global principal investigator of STORM-PE RCT, hematologist at the Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School. "These findings represent a meaningful advancement in optimizing early interventions in patients with intermediate-high risk PE, and we look forward to exploring how changes in RV/LV ratio correlate with other clinical and functional outcomes." 

The rate of major adverse events (MAE) within 7 days — including a composite of PE-related mortality, recurrent PE, clinical deterioration requiring rescue therapy, and major bleeding — was comparable between groups (4.3% [2/47] with CAVT vs. 7.5% [4/53] with anticoagulation alone).

"For the first time, we have prospective, level 1 evidence demonstrating that CAVT with anticoagulation is superior to anticoagulation alone," said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. "Combined with Penumbra's strong prospective data from STRIKE-PE, this randomized evidence from the STORM-PE trial will play a critical role in advancing PE care and supporting the inclusion of CAVT in future treatment guidelines."

In the U.S., an estimated 900,000 cases of venous thromboembolism, which includes PE, occur annuallyⁱ. PE can be life-threatening, representing the third leading cause of cardiovascular death after heart attack and stroke. ^i,ii. Penumbra's Lightning Flash portfolio is the most advanced mechanical thrombectomy system on the market to address venous and pulmonary thrombus. It features Penumbra's Lightning CAVT technology with the latest dual clot detection algorithms, using both pressure and flow-based processes to detect blood clot and blood flow. The portfolio is designed to help remove blood clots with speed, safety and simplicity, allowing physicians to better navigate the body's complex anatomy and deliver high power aspiration for clot removal.

Additional results from the STORM-PE trial will be presented at the upcoming VEINS (Venous Endovascular Interventional Strategies) and VIVA (Vascular InterVentional Advances) Conference, taking place November 1-4 in Las Vegas, NV.

About STORM-PE

STORM-PE is a pivotal, prospective, multi-center randomized controlled trial that enrolled 100 patients across 22 international sites to evaluate computer assisted vacuum thrombectomy (CAVT) using Penumbra's Lightning Flash™ plus anticoagulation, versus anticoagulation alone, for the treatment of acute intermediate-high risk pulmonary embolism (PE). Conducted in partnership with The PERT Consortium®, the trial's primary efficacy endpoint — reduction in RV/LV ratio at 48 hours — was assessed by a blinded independent core laboratory. All safety events were independently adjudicated by an external clinical events committee.

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: 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 ("SEC"), including our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on February 18, 2025. 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.

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

ⁱⁱ "Pulmonary Embolism: A Clinical Approach," American College of Cardiology. Accessed on Oct. 9, 2025. https://www.acc.org/Latest-in-Cardiology/Articles/2025/02/01/42/Cover-Story-Pulmonary-Embolism#:~:text=Pulmonary%20embolism%20(PE)%20continues%20to,venous%20thromboembolism%20in%20the%20country.