June 16, 2025 – Penumbra, Inc. recently announced the completion of enrollment in the STORM-PE clinical trial. This prospective, multi-center randomized controlled trial enrolled 100 patients 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).
“This is an important milestone that underscores Penumbra’s commitment to transforming care for patients with pulmonary embolism,” said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. “The trial successfully randomized patients well ahead of schedule thanks to the dedication of our clinical partners and the tireless efforts of our internal teams.”
Conducted in partnership with The PERT Consortium, a multi-disciplinary group dedicated to improving the care of patients with PE, the trial aims to provide high-quality evidence on the role of CAVT in improving right heart function and clinical outcomes in this critically ill patient population.
“Pulmonary embolism remains a leading cause of cardiovascular morbidity and mortality, yet treatment strategies for intermediate-high risk patients are not well defined.” said Rachel Rosovsky, MD, MPH, co-global principal investigator of STORM-PE and hematologist at the Massachusetts General Hospital. “The results of this trial will provide level 1 clinical evidence aimed at informing treatment guidelines and patient care.”
In the U.S., an estimated 900,000 cases of symptomatic PE occur annually.[i] Pulmonary embolism can be life-threatening with 10-30 percent of individuals dying within one month of diagnosis.
“We are pleased to announce that STORM-PE has successfully completed enrollment,” said Robert Lookstein, MD, MHCDL co-global principal investigator and professor of radiology and surgery at the Icahn School of Medicine at Mount Sinai. “We congratulate all the sites and the investigators for their dedication and commitment to answering the critical clinical question of whether endovascular therapy with CAVT is superior to medical therapy for acute intermediate-high risk pulmonary embolism.”
Penumbra’s Lightning Flash portfolio mechanical thrombectomy system addresses 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 Lightning Flash catheter is made with MaxID hypotube technology, allowing an inner diameter similar to large-bore catheters while maintaining a lower profile and a soft, atraumatic tip design. They are 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.
For more information about the STORM-PE trial (NCT05684796), please visit www.penumbrainc.com/storm-pe-trial.
[i] “Learn about Pulmonary Embolism,” American Lung Association. Accessed on Oct. 26, 2023. https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism
May 01, 2025 
