Latest Data from Landmark STORM-PE Randomized Controlled Trial Demonstrate that CAVT with Anticoagulation Significantly Improves Functional Outcomes for Patients with Pulmonary Embolism

Rhea-AI Summary

Penumbra (NYSE:PEN) announced STORM-PE randomized controlled trial results (Nov 3, 2025) showing that CAVT plus anticoagulation produced significantly greater improvements versus anticoagulation alone in patients with acute intermediate-high risk pulmonary embolism.

Key numeric findings: refined modified Miller score reduction 42.1% vs 15.6% (2.7x; P<0.001), mean heart rate 80.0 vs 86.4 bpm (P=0.022), 90-day six-minute walk 472m vs 376m (P=0.019) and 94% vs 75% predicted walk distance (P=0.022). Safety through 90 days was comparable with no device-related mortality.

Positive

• Thrombus reduction 42.1% vs 15.6% (2.7× greater)
• Heart rate lower at 48h: 80.0 bpm vs 86.4 bpm
• 90-day walk 472m vs 376m (P=0.019)
• Predicted walk 94% vs 75% of predicted distance
• Comparable safety through 90 days; no device-related mortality

Negative

• None.

Insights

Cardiovascular clinical trial analyst

Randomized STORM-PE data (published Nov 3, 2025) show CAVT plus anticoagulation improves thrombus reduction and functional recovery versus anticoagulation alone.

The trial demonstrates a clinically measurable benefit: a 42.1% versus 15.6% relative reduction in refined modified Miller score at 48 hours (P < 0.001), faster physiological recovery (heart rate 80.0 bpm vs 86.4 bpm, P = 0.022), lower tachycardia rates (2.2% vs 20%, P = 0.008), reduced supplemental oxygen need (0.5 L/min vs 1.4 L/min, P = 0.027), and superior functional outcomes including greater odds of PVFS recovery (P = 0.032) and longer 90‑day six‑minute walk distance (472m vs 376m, P = 0.019). These are objective, clinically relevant endpoints that support efficacy claims and were peer‑reviewed and published in a major journal, strengthening internal validity.

Reported safety through 90 days appears comparable between arms with no device‑related mortality and no increase in symptomatic PE recurrence; that parity in harms is crucial when weighing adoption. Key dependencies include patient selection (acute intermediate‑high risk PE as specified), operator experience with the Lightning Flash/CAVT platform, and generalizability beyond trial sites. Watch for guideline committee reviews, incorporation of these primary outcomes into practice statements, and any subgroup or long‑term safety data published after Nov 3, 2025; these will determine real‑world uptake over the next 6–24 months.

• The STORM-PE RCT data presented at the VIVA 2025 Conference showed PE patients treated with CAVT in combination with anticoagulation demonstrated significantly greater improvements in thrombus burden reduction, heart rate, oxygen requirement, and functional outcomes compared to those who received only anticoagulation
• Results of STORM-PE demonstrating superior efficacy of CAVT with anticoagulation versus anticoagulation alone were also published in Circulation today

ALAMEDA, Calif., Nov. 3, 2025 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN) announced additional results of the ground-breaking STORM-PE randomized controlled trial (RCT), which found that the use of computer assisted vacuum thrombectomy (CAVT™) with anticoagulation achieved significantly greater improvements in thrombus burden reduction, heart rate, oxygen requirement, and functional outcomes compared to anticoagulation alone in patients with acute intermediate-high risk pulmonary embolism (PE). The data were presented at this week's Vascular Interventional Advances (VIVA) 2025 Conference. The primary results were also published today in American Heart Association's journal Circulation.

"The latest STORM-PE findings demonstrate substantial improvements in both clinical and functional outcomes, with a significantly higher proportion of patients treated with CAVT plus anticoagulation returning to normalization within 48 hours compared to anticoagulation alone—a remarkable result," Rachel Rosovsky, MD, MPH, co-global principal investigator of STORM-PE RCT, hematologist at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School. "STORM-PE highlights the critical importance of early intervention in patients with intermediate-high risk PE and provides the strongest evidence to date that advanced therapy with CAVT offers superior efficacy compared to the current standard treatment of anticoagulation alone. These breakthrough results not only advance the field but also have the potential to meaningfully improve patient care and recovery."

In the trial, patients treated with CAVT plus anticoagulation experienced:

• Significantly lowered thrombus burden at 48 hours, with a 2.7 times larger reduction in refined modified Miller score (42.1% vs. 15.6% relative reduction; P < 0.001)
• Early physiological recovery with significantly lower heart rate (80.0 bpm vs 86.4 bpm; P = 0.022) and less tachycardia (heart rate > 100, 2.2% vs 20%; P = 0.008), reduced supplemental oxygen requirements (0.5 L/min vs 1.4 L/min; P = 0.027), and a lower NEWS2 risk of clinical deterioration (1.8 vs. 2.7; P = 0.034) at 48 hours
• 2.2 times greater likelihood of progressing towards recovery of functional status, based on post-venous thromboembolism functional status (PVFS) from pre-PE event to discharge (P = 0.032)
• Significantly longer distance walked during the 90-day six-minute walk test (472m vs 376m; P = 0.019). Additionally, CAVT patients near normalized by 90-days, walking 94% of their predicted walk distance vs 75% in the anticoagulation only arm (P = 0.022)
• Safety rates through 90 days were comparable, with no device-related mortality, no additional PE-related mortality > 7 days, and no difference in symptomatic PE-recurrence, confirming the safety profile of CAVT.

"These impressive functional outcomes combined with superior reduction in right heart strain add to the growing body of evidence demonstrating the significant impact CAVT can have on acute PE patients," 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. "This is a foundational trial that will significantly advance PE care, allowing these advanced therapies to be offered to more patients, improving patient outcomes, and potentially leading to the inclusion in future treatment guidelines."

As published today in Circulation, STORM-PE primary outcomes show that patients treated with CAVT in addition to anticoagulation achieved superior reduction in right heart strain with a comparable safety profile versus anticoagulation alone in patients with acute intermediate-high risk PE. These findings were also presented at the Transcatheter Cardiovascular Therapeutics^® (TCT^®), the annual scientific symposium of the Cardiovascular Research Foundation^® (CRF^®), last week.

"STORM-PE confirms that mechanical thrombectomy with CAVT has a significant impact on clinical and functional outcomes," said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. "The STORM-PE results demonstrate that CAVT can rapidly and safely improve patient outcomes and should be considered as a therapeutic option for patients with acute intermediate-high risk PE."

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.

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.

Contact
Jennifer Heth	Parinaz Farzin
Penumbra, Inc	Merryman Communications
jheth@penumbrainc.com	parinaz@merrymancommunications.com
510-995-9791	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

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.

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SOURCE Penumbra, Inc.

FAQ

What did Penumbra announce about STORM-PE results on Nov 3, 2025 for PEN?

Penumbra reported STORM-PE RCT data showing CAVT plus anticoagulation produced larger thrombus reduction and better functional recovery versus anticoagulation alone.

How much greater was thrombus reduction with CAVT in STORM-PE (PEN)?

Refined modified Miller score fell 42.1% with CAVT versus 15.6% with anticoagulation alone (2.7× greater; P<0.001).

What functional improvements did PEN report at 90 days after CAVT in STORM-PE?

CAVT patients walked 472m vs 376m in six-minute walk (P=0.019) and reached 94% vs 75% of predicted distance (P=0.022).

Were there safety differences reported for CAVT in the STORM-PE trial (PEN)?

Safety through 90 days was comparable between arms, with no device-related mortality and no excess PE-related mortality beyond seven days.

Which clinical measures improved at 48 hours in STORM-PE for PEN’s CAVT arm?

At 48 hours the CAVT arm showed lower heart rate (80.0 vs 86.4 bpm), less tachycardia, reduced oxygen needs (0.5 vs 1.4 L/min), and lower NEWS2 score.