New STORM-PE Data Show Computer Assisted Vacuum Thrombectomy with Anticoagulation Resulted in Significantly Better Functional Outcomes at 90 Days Compared to Anticoagulation Alone for Pulmonary Embolism Patients

ALAMEDA, Calif., April 13, 2026 /PRNewswire/ -- Penumbra, Inc. (NYSE:PEN) announced 90-day results of the landmark STORM-PE randomized controlled trial (RCT), which found that patients with acute intermediate-high risk pulmonary embolism (PE) who were treated with computer assisted vacuum thrombectomy (CAVT™) plus anticoagulation achieved greater functional improvement, including walking significantly further and a higher proportion of patients achieving NYHA Class I (no physical limitations), compared to anticoagulation alone. The first-of-its kind data were presented at this week's Society of Interventional Radiology (SIR) Annual Scientific Meeting.

"Together with the initial STORM‑PE results, which demonstrated faster reperfusion and improved right ventricular recovery, this 90 day data highlights significant patient‑centered benefits of CAVT in intermediate‑high risk PE," said Robert Lookstein, MD, MSc, co‑global principal investigator of the STORM‑PE randomized controlled trial and professor of radiology and surgery at the Icahn School of Medicine at Mount Sinai. "This pivotal trial continues to build important clinical evidence supporting the role of endovascular therapy beyond anticoagulation alone and helps inform how treatment strategies including CAVT for PE may continue to evolve in future clinical guidelines."

At 90 days, patients treated with CAVT plus anticoagulation:

• Walked significantly longer distances during the six-minute walk test (479m vs 368m; P=0.003).
• Near normalized, walking 94% of their predicted walk distance vs 75.2% in the anticoagulation only arm (P=0.022).
• Experienced no physical limitation based on New York Heart Association (NYHA) Functional Class Scale compared to the anticoagulation only arm (97% vs 76%, P = 0.022).
• Returned to pre-PE functional status distribution while the anticoagulation only arm did not.
• Improved quality of life and reduced shortness of breath, which were comparable in both arms.

Additionally, safety rates through 90 days were comparable in both arms, with no device-related mortality, no additional PE-related mortality past 7 days, and no difference in symptomatic PE-recurrence, confirming the safety profile of CAVT^[i].

"STORM-PE continues to highlight emerging benefits of treatment beyond anticoagulation alone for patients with intermediate‑high risk PE," said Rachel Rosovsky, MD, MPH, co‑global principal investigator of the STORM‑PE randomized controlled trial, hematologist at Massachusetts General Hospital, and associate professor of medicine at Harvard Medical School. "These functional endpoints are important because they reflect outcomes that matter to patients and directly affect their daily lives. Collectively, the STORM‑PE data suggest that PE care is evolving, and that the thoughtful adoption of endovascular treatment options has the potential to greatly improve patient outcomes and recovery."

Additionally, new interim analysis from STRIKE-PE, highlighting long-term quality-of-life data and functional outcomes in male and female PE patients who received CAVT, will be presented at SIR on April 15. STRIKE-PE is a prospective, international, multicenter study evaluating real-world safety, performance and long-term quality-of-life outcomes of CAVT in up to 1,500 patients.

"Historically, there has been limited randomized evidence describing how different treatment strategies for PE influence longer‑term recovery," said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. "In STORM‑PE, those treated with CAVT achieved significantly greater gains in objective functional measures, including 6‑minute walk distance, compared to anticoagulation alone. Data from STRIKE-PE support a similar recovery trajectory in a broader patient population. Together, these findings provide robust evidence supporting a greater role for CAVT in the treatment of acute intermediate‑high risk PE and reinforce its impact on physiological and functional outcomes."

In the U.S., an estimated 900,000 cases of venous thromboembolism, which includes PE, occur annually.^[ii] PE can be life-threatening, representing the third leading cause of cardiovascular death after heart attack and stroke.^[iii]. Penumbra's Lightning Flash™ portfolio is the most advanced mechanical thrombectomy system on the market, and the only CAVT system designed 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.

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: 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.

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^[i] STORM-PE was not powered to detect differences in safety

^[ii] "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

^[iii] "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.

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SOURCE Penumbra, Inc.