Penumbra (NYSE:PEN) announced today that it completed enrollment in the STORM-PE trial of its Lightning Flash system.
STORM-PE evaluates Lightning Flash computer-assisted vacuum thrombectomy (CAVT) plus anticoagulation. It pits that against anticoagulation alone in the treatment of acute intermediate-high risk pulmonary embolism (PE). The study completed enrollment after bringing on 100 patients for evaluation.
Penumbra said the trial, conducted in partnership with The PERT Consortium, 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.
Dr. Rachel Rosovsky, a hematologist at Massachusetts General Hospital, said the study aims to inform treatment guidelines and care.
“This is an important milestone that underscores Penumbra’s commitment to transforming care for patients with pulmonary embolism,” said Dr. James F. Benenati, 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.”
Lightning Flash is a mechanical thrombectomy system that addresses venous and pulmonary thrombus. It features Penumbra’s Lightning Intelligent Aspiration technology and the latest dual clot detection algorithms. Those algorithms utilize both pressure- and flow-based processes to detect blood clot and blood flow.
The Lightning Flash catheter features MaxID hypotube technology, allowing an inner diameter similar to large-bore catheters. Meanwhile, it still maintains a lower profile and soft, atraumatic tip design. The system helps physicians better navigate the body’s complex anatomy and deliver high power aspiration for clot removal.
