• First-of-its-kind randomized controlled trial comparing computer assisted vacuum thrombectomy (CAVT) using Penumbra's Lightning Flash™ with anticoagulation versus anticoagulation alone
• Penumbra's Indigo^® Aspiration with Lightning portfolio offers the only CAVT technologies currently available in the U.S. and Lightning Flash is the latest advancement designed to allow physicians to remove large blood clots in the body safely, simply and with speed

ALAMEDA, Calif., Nov. 28, 2023 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced the first patient enrolled in STORM-PE, a first-of-its-kind prospective, multi-center, randomized controlled trial evaluating anticoagulation alone vs anticoagulation plus Lightning Flash™ for the treatment of pulmonary embolism (PE). In partnership with PERT Consortium™, a multi-disciplinary group dedicated to improving the care of patients with PE, the STORM-PE trial aims to advance the understanding of the role of computer assisted vacuum thrombectomy (CAVT) in the management of acute PE, with a goal of improving the outcomes for patients with this life-threatening condition.

"STORM-PE is the first head-to-head trial comparing anticoagulation, the mainstay and standard of care for treating acute PE, to CAVT," said Rachel Rosovsky, MD, MPH, co-global principal investigator of STORM-PE, hematologist and clinical investigator at the Massachusetts General Hospital. "We have already seen the significant impact Lightning Flash can have on patients. 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."

STORM-PE will enroll up to 100 participants at up to 20 sites. Penumbra's 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 hypotube-based Indigo Aspiration Catheters with Lightning^TM Intelligent Aspiration, a unique computer assisted clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which may lower the risk of bleeding complications.

"Enrolling the first patient in STORM-PE RCT is an important milestone," said Nicolas J. Mouawad, MD, MPH, MBA, RPVI, chief of vascular and endovascular surgery, McLaren Health Care, Bay City, MI. "This landmark RCT will be instrumental to advancing the standard of care for patients with pulmonary embolism."

"Endovascular therapy has been shown to be an increasingly safe and effective treatment for patients with a symptomatic acute pulmonary embolism," 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 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."

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 diagnosisⁱ.

"Our commitment to clinical research and innovation enables us to lead with insight and continue to pioneer interventional therapies that have a significant impact on patients such as our CAVT technologies," said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. "In partnership with PERT Consortium, we are committed to generating robust clinical evidence that will help transform care so patients, especially those with serious conditions such as PE, can return home quickly and live fully."

About Penumbra 

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra supports healthcare providers, hospitals and clinics in more than 100 countries. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn.

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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