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Jul 01, 2023

Penumbra Expands Computer

News provided by 01 Jun, 2023, 09:00 ET Share this article ALAMEDA, Calif., June

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01 Jun, 2023, 09:00 ET

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ALAMEDA, Calif., June 1, 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 Bolt™ 7, the most advanced and powerful arterial thrombectomy system on the market. Lightning Bolt 7 introduces a new method for removing blood clots, modulated aspiration, which pairs Penumbra's Lightning Intelligent Aspiration technology with an advanced microprocessor algorithm. When used together, Lightning Bolt 7 is designed to enhance the ability to rapidly remove large, fibrous blood clots in the arteries with minimal blood loss, addressing conditions such as acute limb ischemia (ALI), hibernating thrombus and visceral occlusions.

"The unique mechanism of Lightning Bolt 7 provides modulated aspiration at the tip of the catheter, enabling the quick removal of these rigid and stiff blood clots, which oftentimes require open surgery and frequently result in amputation," said Kalyan Veerina, M.D., interventional cardiologist at Cardiovascular Institute of the South (CIS). "Advancements like Lightning Bolt 7 provide a critical frontline option for physicians to treat patients and improve patient outcomes."

Powered by the Penumbra ENGINE®, Lightning Bolt 7 is engineered to detect the difference between blood clot and blood flow. Additionally, it is designed to identify friction within the catheter and orchestrate the rapid opening and closing of the valves to disrupt any resistance between the clot and the catheter tip. This facilitates maximum vacuum force at the catheter tip for optimal, rapid ingestion of blood clots. Lightning Bolt 7 is compatible with Penumbra's arterial catheters, which are made with MaxID hypotube technology, allowing a larger inner diameter while maintaining a lower profile and a soft, atraumatic tip design to maximize the circumferential sweep in the artery.

"This era of computer-aided technology offers the promise of unheralded procedural efficiency that was not previously available to endovascular specialists," said Sahil A. Parikh, M.D., Director of Endovascular Services at Columbia University Irving Medical Center. "Our ability to rapidly revascularize vessels with minimal blood loss is exceptional with these intelligent devices."

"Technologically, Lightning Bolt 7 is a big leap forward," said Raghu Motaganahalli, MD, FRCS, FACS, DFSVS, vascular surgeon with Indiana University Health Physicians. "The computer-aided components offer a safety profile that, when combined with the clot removal speed and efficiency, will promote an endovascular-first approach for a broader range of cases before considering open surgery."

Lightning Bolt 7 received FDA clearance and became available in March 2023. It is part of Penumbra's Indigo® System with Lightning portfolio, which are the only computer-aided mechanical thrombectomy systems currently available in the U.S. Prior to the availability of Lightning Bolt 7, data with the Indigo System have shown excellent 30-day limb salvage rates in more than 98% of patients, short procedure times with an average of 22 minutes and low 30-day mortality at 3%.1

"With our latest advancements in computer-aided technologies, Penumbra offers one of the most comprehensive mechanical thrombectomy product lines for arterial, venous, pulmonary and mesenteric thrombus," said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. "Lightning Flash and Lightning Bolt 7 will continue to advance the standard of care for these difficult conditions, removing clot from the body quickly, safely, in a single session, and without the need for lytics or open surgery, potentially improving quality of life for our patients."

About PenumbraPenumbra, 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 InformationAdditional 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 here.

Forward-Looking StatementsExcept 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, 2022 filed with the SEC on February 23, 2023. 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.

Contact

Jennifer Heth

Parinaz Farzin

Penumbra, Inc.

Merryman Communications

[email protected]

[email protected]

510-995-9791

310.600.6746

1 Lyden, S et al. A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System (STRIDE). Presented at: CX 2023, the Charing Cross International Symposium April 25-27; London, United Kingdom.

SOURCE Penumbra, Inc.