ALAMEDA, Calif., Jan. 10, 2023 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced the U.S. Food and Drug Administration (FDA) clearance and launch of Lightning Flash™, the most advanced and powerful mechanical thrombectomy system on the market. Lightning Flash features Penumbra's novel Lightning Intelligent Aspiration technology, now with dual clot detection algorithms. Together with innovative catheter engineering, Lightning Flash is designed to quickly remove large blood clots in the body, including venous thrombus and pulmonary emboli (PE).     

Penumbra's Lightning Flash is the most advanced and powerful mechanical thrombectomy system on the market. It 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, M.D., 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 U.S. and early data have shown improvement in clinical outcomes and quality of lifeⁱ.

"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."

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.

Important Safety Information
Additional information about Penumbra's products can be located on Penumbra's website at http://www.penumbrainc.com/healthcare-professionals. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. Risk information can be found here.

Forward-Looking Statements
Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: the impact of the COVID-19 pandemic on our business, results of operations and financial condition; failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; potential adverse regulatory actions; and the potential impact of any acquisitions, mergers, dispositions, joint ventures or investments we may make. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 22, 2022. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.

SOURCE:- PRNewswire