Penumbra Study Shows Wearables Improve Pulmonary Embolism Recovery

ALAMEDA, Calif., Oct. 6, 2026 /CourierPR/ -- Penumbra, Inc., a leading thrombectomy company, announced new insights from a subset analysis of the landmark STORM-PE randomized controlled trial, the first trial to demonstrate a significant correlation between real-world, daily step-based activity 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.

The 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) compared to anticoagulation alone.

A cohort of the trial patients were discharged with a fitness watch to track daily step count, walking bout length, number of walking bouts, walking bout duration, and peak 10-minute step count. STORM-PE investigators performed a correlation analysis between watch actigraphy data and made comparisons to the 6-minute walk test performed at 30- and 90-day follow-up visits.

Key findings of this subset analysis included significant correlations between total daily step count, walking bout length, number of walking bouts, walking bout duration, and peak 10-minute step count and 30-day 6-minute walk test performance. The correlations were strongest with temporally matched wearable and clinic data at 30 days and attenuated with 90-day follow-up data. Wearable technology provided a complementary measure of functional recovery after PE.

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.

In the U.S., an estimated 900,000 cases of venous thromboembolism, including PE, occur annually. PE remains the third leading cause of cardiovascular death after heart attack and stroke. 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.