New STORM-PE Data Demonstrate Correlation Between Clinical Assessments and Real-world Functional Recovery Captured Through Wearable Technology in Patients with Pulmonary Embolism
Wearable-derived data provide new insights into how clinical outcomes for patients treated with CAVT and anticoagulation, and anticoagulation alone translate to patients’ everyday recovery
Wearable-derived data provide new insights into how clinical outcomes for patients treated with CAVT and anticoagulation, and anticoagulation alone translate to patients’ everyday recovery
ALAMEDA, Calif. — Penumbra, Inc. announced results from a subset analysis of the landmark STORM-PE randomized controlled trial (RCT), the first trial to demonstrate a significant correlation between real-world, daily step-based activity as captured on a consumer wearable device and patient performance in the clinical 6-minute walk test. The findings were presented at this week’s Vascular InterVentional Advances (VIVA) meeting.
STORM-PE RCT assessed patients with acute intermediate-high risk pulmonary embolism (PE) who were treated with computer assisted vacuum thrombectomy (CAVT™) plus anticoagulation compared to anticoagulation alone. Data from the trial showed patients treated with CAVT plus anticoagulation experienced improved right ventricular recovery and achieved greater functional improvement, including walking significantly further and a higher proportion of patients achieving NYHA Class I (no physical limitations)i compared to anticoagulation alone.
A cohort of the trial patients were discharged with a fitness watch to track a patient’s activity, including actigraphy measures during everyday living. STORM-PE investigators performed a correlation analysis between watch actigraphy (daily total step count, walking bout data, and daily peak steps) and made comparisons to the 6-minute walk test performed at 30- and 90-day follow-up visits.
“STORM-PE is the first RCT in pulmonary embolism therapy to incorporate data from a consumer wearable device, representing an important step forward in understanding how office assessed clinical improvements translate into meaningful real-world recovery,” said Robert Lookstein, M.D., MSc, global co principal investigator of the STORM PE RCT and professor of radiology and surgery at the Icahn School of Medicine at Mount Sinai. “This innovation enables the scientific community to determine whether improvements observed during office assessments are reflected in patients’ real-world experiences at home.”
Key findings of this subset analysis include:
- Total daily step count, walking bout length, number of walking bouts, walking bout duration and peak 10-minute step count were significantly correlated with 30-day 6-minute walk test performance.
- Correlations were strongest with temporally matched wearable and clinic data at 30 days and attenuated with 90-day follow up data.
- Wearable technology provides a complementary measure of functional recovery after PE.
“This STORM-PE subset gives us a more complete picture of patient recovery by allowing us to compare data collected in the clinic with information gathered as patients go about their daily lives,” said Rachel Rosovsky, M.D., MPH, global co-principal investigator of the STORM PE RCT, hematologist at Massachusetts General Hospital, and associate professor of medicine at Harvard Medical School. “By generating a more comprehensive view of patient outcomes, these findings have the potential not only to advance our understanding of the role of endovascular therapy in PE, but also to help shape the design of future clinical trials.”
Complementing the STORM-PE findings, investigators presented a new interim analysis of 1,000 prospective patients from the STRIKE-PE trial, looking at one-year functional outcomes and quality of life for PE patients after CAVT during the 16th Venous Endovascular INterventional Strategies (VEINS) meeting. STRIKE-PE continues to support the safety and effectiveness of CAVT, including short device times and low adverse events, for treating PE. The study also found longer-term functional outcomes and quality of life benefits, including sustained reduced dyspnea, increased walking distance, restored functional status and improved quality of life. STRIKE-PE is a prospective, international, multicenter study evaluating real-world safety, performance and long-term functional and quality-of-life outcomes of CAVT in up to 1,500 patients.
“At Penumbra, we are committed to advancing innovations that are supported by rigorous clinical evidence,” said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. “By incorporating consumer wearables into STORM-PE, we have a unique opportunity to evaluate whether the clinical improvements observed in traditional assessments are reflected in patients’ day-to-day recovery at home. Together with emerging data from STRIKE-PE, these findings contribute to a growing body of evidence supporting a significant role for CAVT in the treatment of PE.”
In the U.S., an estimated 900,000 cases of venous thromboembolism, including PE, occur annually.ii PE remains 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.
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.
