Penumbra Announces the European Launch of the Indigo® System With Lightning™ 7 and Lightning 12 Intelligent Aspiration

Rhea-AI Summary

Penumbra, Inc. (NYSE: PEN) has launched its advanced Indigo Aspiration System technologies, Lightning 7 and Lightning 12, in Europe following CE Mark approval. These systems, focused on mechanical thrombectomy for removing blood clots in a single session, aim to enhance patient outcomes by differentiating between clot and blood to minimize blood loss. Physicians in Europe now have access to this innovative technology, which has already shown success in the U.S. market, potentially reducing ICU stays and improving care efficiency.

Positive

• Launch of Lightning 7 and Lightning 12 in Europe after CE Mark approval.
• Technologies designed for single session blood clot removal, enhancing patient outcomes.
• Differentiates between clot and blood to minimize blood loss, potentially reducing healthcare costs.

Negative

• None.

• Physicians in Europe now have access to Penumbra’s most advanced mechanical thrombectomy technology available, which has had a significant impact on patients in the U.S.
• Designed for single session blood clot removal in peripheral arterial and venous systems, including the treatment of pulmonary embolisms
• First and only computer-aided mechanical aspiration technology that can differentiate between clot and blood, which is designed to minimize blood loss

ALAMEDA, Calif.--(BUSINESS WIRE)-- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced that its Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark (Conformité Européenne) and are now commercially available in Europe. Both technologies are part of Penumbra’s Indigo Aspiration System – now with Intelligent Aspiration for mechanical thrombectomy – and are designed for single session arterial and venous thrombus removal, including the treatment of pulmonary embolisms.

Now available in Europe, Penumbra’s Lightning 7 and Lightning 12 are designed for single session arterial and venous thrombus removal, including the treatment of pulmonary embolisms. (Graphic: Business Wire)

“Technology advancements such as Lightning 7 and Lightning 12 are critical to improving patient outcomes and expanding use of mechanical thrombectomy to a broader range of patients,” said Dr. Andrew Wigham, interventional radiology consultant at John Radcliffe Hospital, Oxford, UK. “Lightning enables us to remove blood clots in the body quickly and efficiently, often in a single session, while also minimizing blood loss and potentially reducing the need for thrombolytics and prolonged ICU stays.”

Powered by the Penumbra ENGINE^®, Lightning 7 and Lightning 12 combine the new Indigo System CAT™7 and CAT12 Aspiration Catheters with Lightning Intelligent Aspiration, a unique computer-aided clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which may lower the risk of bleeding complications. The Lightning technology also provides an alternative to other surgical options. CAT7 is a high power, low profile catheter that features laser-cut hypotube technology and circumferential sweep designed for dependable delivery and maximal clot extraction. CAT12 is a large-lumen aspiration catheter that also incorporates novel laser-cut hypotube-based catheter engineering to provide advanced deliverability and torqueability within the body.

“The launch of our Lightning portfolio in Europe will provide a much-needed option for physicians to address debilitating blood clots in the body effectively and efficiently,” said James Benenati, MD, FSIR, chief medical officer at Penumbra, Inc. “We’ve seen our latest advancements in mechanical thrombectomy reduce blood loss while increasing clot removal efficiency in the U.S. These innovations may help improve patient care compared to conventional therapy. We are now able to help more patients with this technology by expanding access to physicians in Europe.”

“Blood clots in the body can be difficult to access and are potentially life-threatening. Until now, treatment options have been limited,” said Joan Kristensen, vice president and head of the Europe, Middle East and Africa region for Penumbra, Inc. “The introduction of our Lightning portfolio in Europe will expand access of our most advanced clot removal technology for the body, which combines intelligent aspiration and innovative catheter engineering to remove blood clots in a single session. With Lightning, mechanical aspiration technology continues to advance to meet the needs of patients, which is our core purpose at Penumbra.”

About Indigo System with Lightning Intelligent Aspiration

The Indigo System with Lightning is an intelligent aspiration system powered by Penumbra ENGINE. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. This unique mechanism of action helps optimize thrombus removal procedures by differentiating between thrombus and blood. The system is designed to aspirate continuously when in thrombus and intermittently in patent flow. Throughout the case, Lightning provides procedural feedback via audiovisual cues. Lightning’s thrombus removal algorithm is designed to initiate automatic valve clicking when it senses patent flow. With automatic valve control, Lightning is designed to help reduce blood loss and allow the physician to focus on optimizing thrombus removal procedures.

The Indigo System with Lightning Intelligent Aspiration and Separators is indicated for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for treatment of pulmonary embolism. For more information, please visit https://www.penumbrainc.com/indigo-lightning/.

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: Penumbra, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220414005358/en/

Jennifer Heth

Penumbra, Inc.

jheth@penumbrainc.com

510-995-9791

Joni Ramirez

Merryman Communications

joni@merrymancommunications.com

323.532.0746

Source: Penumbra, Inc.

FAQ

What new technology has Penumbra launched in Europe?

Penumbra has launched the Indigo Aspiration System technologies, Lightning 7 and Lightning 12, in Europe.

What is the purpose of Penumbra's Lightning technologies?

Lightning technologies are designed for single session blood clot removal, improving patient outcomes by minimizing blood loss.

How does the Lightning technology work?

The Lightning technology differentiates between clot and blood to enhance the efficiency of thrombus removal, reducing the need for thrombolytics.

What impact has Penumbra's technology had in the U.S.?

The technology has shown significant success in the U.S. market, improving patient care and reducing the duration of ICU stays.