Mechanical Thrombectomy System Receives FDA Clearance

Penumbra Inc. received US FDA clearance for Lightning Flash, an advanced mechanical thrombectomy system designed to quickly remove large blood clots in the body, including venous thrombus and pulmonary emboli (PE). Lightning Flash features Penumbra's novel Lightning Intelligent Aspiration technology, now with dual clot detection algorithms.

"Penumbra's Lightning Flash gives physicians a highly torqueable, larger catheter that is designed to remove a large clot burden in the pulmonary arteries or deep venous system more efficiently while maintaining an excellent safety profile because of Lightning's computer-aided algorithms," said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. "We believe that patients can have improved outcomes with this new technology because of the exceptional trackability and unique ability to distinguish flowing blood from clot."

Lightning Flash, powered by the Penumbra ENGINE, uses both pressure and flow-based algorithms to detect blood clot and blood flow. The Lightning Flash catheter is made with MaxID hypotube technology, allowing an inner diameter similar to large-bore catheters while maintaining a lower profile and a soft, atraumatic tip designed to help navigate the complex and delicate anatomy of the body. When used together, the device is intended to help remove blood clots quickly while minimizing potential blood loss.

"Lightning Flash will fundamentally change how blood clots are removed from the body," said Adam Elsesser, president and chief executive officer of Penumbra. "With this latest advancement, physicians are more likely to adopt mechanical thrombectomy because a broad spectrum of blood clots can be removed much quicker and less invasively than current interventional or surgical methods. This means that we are able to help even more patients with our technology, which is core to who we are as a company."

Lightning Flash is part of Penumbra's Indigo System with Lightning portfolio. Lightning products are the only computer-aided mechanical thrombectomy systems currently available in the US and early data presented at Vascular InterVentional Advances (VIVA) 2022 have shown improvement in clinical outcomes and quality of life.

"Penumbra's commitment to innovation and clinical excellence enables us to pioneer interventional therapies that have a significant impact on patients," said Sandra Lesenfants, president of interventional at Penumbra, Inc. "Innovations such as Lightning Flash will continue to transform the standard of care for these difficult conditions, ultimately improving patient outcomes and allowing patients to return home quickly."