News | Cardiovascular Business | January 11, 2023

FDA Clearance and Launch Granted to Penumbra Mechanical Thrombectomy System

Alameda, Calif.-based global healthcare company Penumbra has announced U.S. Food & Drug Administration (FDA) clearance and launch of Lightning Flash, its advanced mechanical thrombectomy system which addresses venous and pulmonary thrombus. 

Alameda, CA-based global healthcare company Penumbra has announced Food & Drug Administration (FDA) clearance and launch of Lightning Flash, which the company reports is the most advanced mechanical thrombectomy system on the market to address venous and pulmonary thrombus.

January 11, 2023 — The Alameda, Calif.-based global healthcare company Penumbra has announced U.S. Food & Drug Administration (FDA) clearance and launch of Lightning Flash, which the company reports is the most advanced mechanical thrombectomy system on the market to address venous and pulmonary thrombus. Next generation technology combines superior catheter design with the latest dual clot detection innovation, according to the company’s statement on the new device.

“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,” added Elsesser, noting, “This means that we are able to help even more patients with our technology, which is core to who we are as a company.”

Penumbra also noted that combined with innovative catheter engineering, Lightning Flash is designed to quickly remove large blood clots in the body, including venous thrombus and pulmonary emboli (PE). According to the company, the system features

Penumbra’s novel Lightning Intelligent Aspiration technology, now with dual clot detection algorithms powered by the Penumbra ENGINE; uses both pressure and flow-based algorithms to detect blood clot and blood flow, enabling an excellent safety profile. Additionally, innovative catheter engineering features a highly torqueable, larger catheter made with MaxID hypotube technology; designed to remove a large clot burden in the body, including venous thrombus and PE. 

“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, M.D., FSIR, chief medical officer at Penumbra. He further added, “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.”

Powered by the Penumbra ENGINE, the mechanical thrombectomy system uses both pressure and flow-based algorithms to detect blood clot and blood flow, according to the company. 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 is part of Penumbra’s Indigo System with Lightning portfolio. Lightning products are the only computer-aided mechanical thrombectomy systems currently available in the U.S. and early data have shown improvement in clinical outcomes and quality of life [i]. 

“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.” 

For more information: www.penumbrainc.com

Reference: 

[1] Weinberg, I. Periprocedural and Patient-Reported Quality of Life Outcomes After Computer-Aided Mechanical Aspiration Thrombectomy for the Treatment of Acute Pulmonary Embolism. Presented at: VIVA 22 Oct. 31 – Nov. 3, 2022; Boston, MA.


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