Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest iteration of the Indigo® Aspiration System, Lightning™ 12. As part of the Indigo Aspiration System, Lightning 12 (Indigo System CAT™ 12 Aspiration Catheter with Lightning Intelligent Aspiration) and Separator 12 are now indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems as well as for the treatment of pulmonary embolism.
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The Indigo® Aspiration System Lightning™ 12 received FDA clearance for the treatment of pulmonary embolism. (Photo: Business Wire)
Pulmonary embolism, or PE, is a deadly condition causing blood clots within a patient’s lungs that has grown in prevalence during the COVID-19 pandemic. The Indigo Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots, potentially reducing the need for thrombolytics and their associated ICU stays.
“Penumbra continues to strive to bring innovative therapies to the medical community, and this is another important milestone that will help advance pulmonary embolism intervention,” said Adam Elsesser, president and chief executive officer, Penumbra. “COVID has increased the awareness of the need for therapies that remove blood clots, and we are thrilled with the FDA clearance of the PE treatment indication for Lightning 12.”
The Indigo System Lightning 12 is the company’s newest generation aspiration system for peripheral thrombectomy. Lightning 12 combines the Indigo System CAT™12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system’s unique clot detection mechanism. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to provide advanced deliverability and torqueability within the body. This combination of intelligent aspiration and large-lumen catheter engineering makes Lightning 12 Penumbra’s most advanced clot removal technology for the treatment of pulmonary embolism.
The Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE. For more information, visit https://www.penumbrainc.com/indigo-lightning/.
About Pulmonary Embolism
Pulmonary embolism (PE) is a condition that occurs when blood clots, typically traveling from the veins in the legs, get caught in the arteries of the lungs. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. According to the American Heart Association, PE affects roughly 367,000 Americans per year.1
About Indigo System
The latest generation of Penumbra’s continuous aspiration thrombectomy system features Indigo System Lightning 12 which combines the new Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration powered by Penumbra ENGINE, enabling physicians to focus on optimizing thrombus removal using the system’s unique clot detection mechanism. The Indigo System’s proprietary Separator technology, Separator 12 is also available with Lightning 12 and is designed to enable unobstructed aspiration for the duration of the procedure. Lightning 12 and Separator 12 are designed for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for the treatment of pulmonary embolism.
In addition to Lightning 12, the Indigo System also now includes Lightning 8 which combines the Indigo System CAT 8 Aspiration Catheter with Lightning Intelligent Aspiration for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company’s proprietary continuous, mechanical vacuum aspiration pump.
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.
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 sells its products to hospitals and healthcare providers primarily through its direct sales organization in the U.S., most of Europe, Canada and Australia, and through distributors in select international markets. Penumbra, the Penumbra P logo, Indigo, CAT, Separator, Lightning, and Penumbra ENGINE are trademarks of Penumbra, Inc. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn.
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; and potential adverse regulatory actions. 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, 2019 filed with the SEC on February 26, 2020, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC on May 7, 2020, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the SEC on August 3, 2020, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the SEC on November 2, 2020. 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.
1Virani, S.S. et al. on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation. 2020;141(9):e139–e596.
Source: Penumbra, Inc.