Penumbra Enrolls First Patient in STORM-PE Trial for Lightning Flash Thrombectomy in Acute PE

November 28, 2023—Penumbra, Inc. announced that the first patient was enrolled in the prospective, multicenter STORM-PE randomized controlled trial (RCT), which is evaluating anticoagulation alone versus anticoagulation plus Penumbra’s Lightning Flash for the treatment of pulmonary embolism (PE).

“Enrolling the first patient in STORM-PE RCT is an important milestone,” commented Nicolas J. Mouawad, MD, in the company’s press release. Dr. Mouawad, MD, who is Chief of Vascular and Endovascular Surgery at McLaren Health Care in Bay City, Michigan, added, “This landmark RCT will be instrumental to advancing the standard of care for patients with pulmonary embolism.”

According to the company, Lightning Flash can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems and can be used for the treatment of PE. Lightning Flash combines the company’s hypotube-based Indigo aspiration catheters with Lightning intelligent aspiration. Lightning intelligent aspiration is a computer-assisted clot detection technology that differentiates between clot and blood and is designed to reduce blood loss and the need for clot-dissolving drugs, which may lower the risk of bleeding complications.

STORM-PE will enroll up to 100 patients at up to 20 sites. In partnership with PERT Consortium, the trial aims to advance the understanding of the role of computer-assisted vacuum thrombectomy (CAVT) in the management of acute PE.

The study’s coglobal Principal Investigators are Rachel Rosovsky, MD, and Robert Lookstein, MD. Dr. Rosovsky is a hematologist and clinical investigator at the Massachusetts General Hospital in Boston, Massachusetts. Dr. Lookstein is Professor of Radiology and Surgery at the Icahn School of Medicine at Mount Sinai in New York, New York.

“STORM-PE is the first head-to-head trial comparing anticoagulation—the mainstay and standard of care for treating acute PE—to CAVT,” commented Dr. Rosovsky in Penumbra’s press release. “We have already seen the significant impact Lightning Flash can have on patients.”

Dr. Rosovsky continued, “The results generated from this pivotal RCT study will provide level 1 evidence of how CAVT compares to current treatment paradigms and will inform us if treatment guidelines need to include this technology as a frontline therapeutic option in patients with intermediate high-risk PE.”

Dr. Lookstein stated in the press release, “Endovascular therapy has been shown to be an increasingly safe and effective treatment for patients with a symptomatic acute pulmonary embolism. We are proud to commence enrollment in the STORM-PE trial. This trial is designed to answer whether CAVT plus anticoagulation can restore normal function to the failing right ventricle faster and more reliably than anticoagulation alone.”

“We are confident this trial will generate foundational data leading to the next generation of randomized studies in the field of venous thromboembolism for years to come,” advised Dr. Lookstein in Penumbra’s press release.