• Lightning Flash™ 2.0 features advanced computer assisted vacuum thrombectomy (CAVT) software, designed for increased efficiency and sensitivity to enhance removal of venous thrombus and treatment of pulmonary emboli (PE)
• Combined with streamlined audio-visual feedback, Lightning Flash 2.0 is designed to enable physicians to restore blood flow more quickly and further minimize blood loss

ALAMEDA, Calif., April 23, 2024 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), the world's largest thrombectomy company, announced the U.S. Food and Drug Administration (FDA) clearance and launch of Lightning Flash™ 2.0, the next generation computer assisted vacuum thrombectomy (CAVT) system to remove venous thrombus and treat pulmonary emboli (PE). Lightning Flash 2.0 features advanced Lightning Flash algorithms, designed for increased speed and sensitivity to thrombus and blood flow. These new advancements combined with Penumbra's novel catheter technology allow physicians to better navigate the body's complex anatomy and deliver high power for clot removal with possible minimal blood loss.

"Based on what we've seen in the initial launch, Lightning Flash 2.0 has significantly improved procedure time by shortening the aspiration time. It has also shown reductions in blood removed during aspiration. These advantages can improve patient safety, provide better outcomes for the patients, and streamline efficiency for physicians treating the patients," said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. "As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 will provide physicians with the confidence that CAVT is a valuable frontline option." 

With streamlined audio-visual feedback, Lightning Flash 2.0 enables physicians to have a better understanding of what is occurring at the tip of the catheter during a procedure. This enhanced feedback loop results in a more intuitive thrombus removal experience for the physician. 

"Lightning Flash 2.0 now combines an optimally sized catheter with the latest algorithm technology designed to more efficiently remove blood clots while maintaining a high level of safety," said Adam Elsesser, president and chief executive officer of Penumbra. "Our ongoing innovation around CAVT underscores our commitment to advancing patient care so that more patients suffering from these complicated conditions can benefit from this advanced therapy."

Lightning Flash 2.0 is part of Penumbra's Indigo® System with Lightning® portfolio. The company's Lightning products are the only computer assisted mechanical thrombectomy systems currently available in the U.S. and early clinical data has demonstrated improvement in patient clinical outcomes and quality of lifeⁱ.

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. 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 https://www.penumbrainc.com/providers. 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 at http://www.peninc.info/risk.

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: 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 (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 22, 2024. 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.

ⁱ 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.