Penumbra, Inc. has announced the completion of enrollment in its landmark STORM-PE clinical trial, a pivotal study that could reshape treatment approaches for patients with acute intermediate-high risk pulmonary embolism. The prospective, multi-center randomized controlled trial enrolled 100 patients to evaluate computer assisted vacuum thrombectomy (CAVT) using Penumbra's Lightning Flash™ technology plus anticoagulation versus anticoagulation alone.
First-of-Its-Kind Clinical Investigation
The STORM-PE trial represents the first clinical study of its kind, specifically designed to compare endovascular intervention with standard medical therapy in intermediate-high risk pulmonary embolism patients. Conducted in partnership with The PERT Consortium®, a multi-disciplinary group dedicated to improving PE patient care, the trial aims to provide high-quality evidence on CAVT's role in improving right heart function and clinical outcomes.
"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."
Addressing Critical Treatment Gaps
The clinical significance of this trial stems from the substantial unmet medical need in pulmonary embolism care. In the United States, an estimated 900,000 cases of symptomatic PE occur annually, with the condition proving life-threatening for many patients—10-30 percent of individuals die within one month of diagnosis.
"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 Massachusetts General Hospital. "The results of this trial will provide level 1 clinical evidence aimed at informing treatment guidelines and patient care."
Advanced Thrombectomy Technology
The trial utilizes Penumbra's Lightning Flash portfolio, described as the most advanced mechanical thrombectomy system on the market for addressing venous and pulmonary thrombus. The system features Lightning CAVT technology with dual clot detection algorithms, using both pressure and flow-based processes to detect blood clot and blood flow.
The Lightning Flash catheter incorporates MaxID hypotube technology, allowing an inner diameter similar to large-bore catheters while maintaining a lower profile and a soft, atraumatic tip design. These features are designed to help remove blood clots with speed, safety and simplicity, allowing physicians to better navigate complex anatomy and deliver high power aspiration for clot removal.
Clinical Trial Design and Objectives
Robert Lookstein, MD, MHCDL, co-global principal investigator and professor of radiology and surgery at the Icahn School of Medicine at Mount Sinai, emphasized the trial's importance: "We are pleased to announce that STORM-PE has successfully completed enrollment. 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."
The completion of enrollment ahead of schedule demonstrates strong clinical interest in advancing treatment options for this patient population. The trial's results are expected to provide definitive evidence on the comparative effectiveness of mechanical thrombectomy versus standard anticoagulation therapy alone in intermediate-high risk PE patients.
Penumbra, which describes itself as the world's leading thrombectomy company, focuses on developing innovative technologies for challenging medical conditions including ischemic stroke, venous thromboembolism such as pulmonary embolism, and acute limb ischemia. The company's broad portfolio centers on removing blood clots from head-to-toe with speed, safety and simplicity, supporting healthcare providers in more than 100 countries.
