Penumbra’s STORM-PE Pivotal Trial of Lightning Flash CAVT Completes Enrollment

June 16, 2025—Penumbra, Inc. announced the completion of enrollment in the pivotal STORM-PE prospective, multicenter, randomized controlled trial.

According to the company, STORM-PE enrolled 100 patients to evaluate computer-assisted vacuum thrombectomy (CAVT) using the Penumbra Lightning Flash plus anticoagulation versus anticoagulation alone for the treatment of acute intermediate-high–risk pulmonary embolism (PE).

Penumbra stated that STORM-PE aims to provide high-quality evidence on the role of CAVT in improving right heart function and clinical outcomes in patients with PE. The trial is being conducted in partnership with the PERT Consortium.

The coglobal Principal Investigators of STORM-PE are Rachel Rosovsky, MD, and Robert Lookstein, MD.

“PE remains a leading cause of cardiovascular morbidity and mortality, yet treatment strategies for intermediate-high–risk patients are not well defined,” commented Dr. Rosovsky in the company’s press release. “The results of this trial will provide level 1 clinical evidence aimed at informing treatment guidelines and patient care.” Dr. Rosovsky is a hematologist at the Massachusetts General Hospital in Boston, Massachusetts.

Dr. Lookstein added, “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 PE.” Dr. Lookstein is Professor of Radiology and Surgery at the Icahn School of Medicine at Mount Sinai in New York, New York.

In November 2023, Penumbra announced commencement of enrollment in STORM-PE.