STORM-PE and STRIKE-PE Data Presented for Penumbra’s CAVT for Pulmonary Embolism

October 6, 2026—Penumbra, Inc., announced new STORM-PE findings examining the relationship between activity recorded by wearable devices and clinic-based assessments of functional recovery after pulmonary embolism (PE). The subset analysis of the randomized controlled trial (RCT) was presented at the Vascular Interventional Advances (VIVA) 2026 conference.

According to Penumbra, the prospective, multicenter, pivotal STORM-PE RCT enrolled 100 patients across 22 international sites to evaluate the company’s computer-assisted vacuum thrombectomy (CAVT) using Penumbra’s Lightning Flash device plus anticoagulation (AC) versus AC alone for the treatment of acute intermediate-high–risk PE.

Previously reported STORM-PE data showed greater right ventricular recovery and functional improvement in patients treated with CAVT plus AC than in those treated with AC alone. Patients in the CAVT arm walked significantly farther, and a higher proportion achieved New York Heart Association class I (no physical limitations). Additional information is available on the company’s STORM-PE study page.

For the subset analysis, a cohort of participants received fitness watches at discharge to record their activity during daily life. Investigators compared these wearable-derived measurements with performance on 6-minute walk tests (6MWTs) conducted at the 30- and 90-day follow-up visits.

At VIVA 2026, the investigators presented data showing that 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 6MWT performance. Correlations were strongest when wearable and clinic measurements were collected at corresponding times at 30 days and less pronounced with the 90-day follow-up data. The findings suggest that wearable devices can supplement clinic-based assessments of functional recovery after PE, noted Penumbra.

Robert Lookstein, MD, and Rachel Rosovsky, MD, are Global Coprincipal Investigators of STORM-PE.

“STORM-PE is the first RCT in PE 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,” commented Dr. Lookstein in Penumbra’s press release. “This innovation enables the scientific community to determine whether improvements observed during office assessments are reflected in patients’ real-world experiences at home.”

Dr. Rosovsky added, “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. 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.”

Penumbra also announced that results from an interim analysis of 1,000 patients from STRIKE-PE were presented at The VEINS conference. The analysis examined functional outcomes and quality of life (QOL) through 1 year after CAVT. The prospective, international, multicenter STRIKE-PE study is evaluating real-world safety, performance, and long-term functional and QOL outcomes of CAVT with Penumbra’s Indigo Lightning 12 aspiration system for the treatment of PE in up to 1,500 patients.

According to the company, the findings showed short device times and low rates of adverse events, as well as sustained improvements in dyspnea, walking distance, functional status, and QOL. Additional information is available on Penumbra’s STRIKE-PE study page.