Penumbra Receives CE Mark for Computer Assisted Vacuum Thrombectomy Technologies - Lightning Flash™ 2.0 and Lightning Bolt™ 7 - in Europe Latest computer assisted vacuum thrombectomy (CAVT) technologies combine superior catheter design with the latest dual clot detection computer...

ALAMEDA, Calif. , Sept. 16, 2024 /PRNewswire/ -- Penumbra, Inc . (NYSE: PEN ), the world's leading thrombectomy company, announced it has secured CE Mark in Europe for the latest computer assisted vacuum thrombectomy (CAVT) technologies – Lightning Flash™ 2.0 and Lightning Bolt™ 7.

"Based on outcomes from our clinical trials and from physicians using our devices globally, our CAVT technologies have greatly improved our ability to rapidly and safely remove clot in the vascular system," said James F. Benenati , M.D., FSIR, chief medical officer at Penumbra. "With quicker procedures and more efficient clot removal, we have improved outcomes while demonstrating a high level of safety. As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 and Lightning Bolt 7 will provide physicians in Europe with the confidence that CAVT is a valuable first line option to manage conditions such as PE, venous thrombosis, and acute limb ischemia."

Penumbra's Lightning products will be the only CAVT systems available in Europe and each are designed to help physicians optimize patient care:

Lightning Flash 2.0 Lightning Flash 2.0 is the most advanced mechanical thrombectomy system on the market to address venous and pulmonary thrombus. It features Penumbra's Lightning Intelligent Aspiration technology with the latest dual clot detection algorithms, using both pressure and flow-based processes to detect blood clot and blood flow. The Lightning Flash 2.0 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 design. It is designed to help remove blood clots with speed, safety and simplicity, allowing physicians to better navigate the body's complex anatomy and deliver high power aspiration for clot removal with minimal blood loss. Additionally, 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.

"We have utilized Penumbra's aspiration technology since the introduction of the first-generation Indigo System, witnessing significant advancements with each new iteration," said Prof. Nils Kucher, Director of the Department of Angiology at the University Hospital Zurich, Switzerland .

"Our team has experience with the 12F system for acute venous thrombosis, and with this latest advancement, we are hopeful that the procedures will be even more efficient for PE and venous thrombosis as we have received positive feedback from colleagues in the U.S."

"We are eagerly anticipating the opportunity to use the new Lightning Flash 2.0 System, as it promises aspiration capabilities to address large clot burden quickly and has the potential to minimize blood loss," said Prof. Stefano Barco , Department of Angiology at the University Hospital Zurich, Switzerland .

Lightning Bolt 7 Lightning Bolt 7 is the most 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. Lightning Bolt 7 is engineered to detect the difference between blood clot and blood flow. Additionally, it is designed to break the friction between the catheter and clot by having the computer algorithms rapidly modulate aspiration to quickly fatigue the thrombus and remove the clot from the arteries. This facilitates maximum vacuum force at the catheter tip for optimal, rapid ingestion of blood clots.

"In my opinion, computer assisted thrombus removal is the future of arterial clot management and offers the promise of peak procedural efficiency that was not previously available to endovascular specialists," said Dr. Gianmarco de Donato , Chief Vascular Surgery Unit, University Hospital of Siena, Italy . "Our ability to rapidly revascularize vessels with minimal blood loss is crucial for achieving optimal patient outcomes."

Lightning Flash 2.0 and Lightning Bolt 7 come on the heels of Penumbra recently receiving CE Mark for five of its stroke reperfusion and access catheters, expanding both its neuro and vascular portfolios in Europe . These latest innovations provide physicians in Europe with a robust selection of devices to remove blood clots throughout the body.

About Penumbra Penumbra, Inc., the world's leading thrombectomy company, is focused on developing the most innovative technologies for challenging medical conditions such as ischemic stroke, venous thromboembolism such as pulmonary embolism, and acute limb ischemia. Our broad portfolio, which includes computer assisted vacuum thrombectomy (CAVT), centers on removing blood clots from head-to-toe with speed, safety and simplicity. By pioneering these innovations, we support healthcare providers, hospitals and clinics in more than 100 countries, working to improve patient outcomes and quality of life. For more information, visit www.penumbrainc.com and connect on Instagram, LinkedIn and X.

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 or other assets; 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.

Penumbra's Lightning products will be the only CAVT systems available in Europe and each are designed to help physicians optimize patient care:

Lightning Flash 2.0 Lightning Flash 2.0 is the most advanced mechanical thrombectomy system on the market to address venous and pulmonary thrombus. It features Penumbra's Lightning Intelligent Aspiration technology with the latest dual clot detection algorithms, using both pressure and flow-based processes to detect blood clot and blood flow. The Lightning Flash 2.0 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 design. It is designed to help remove blood clots with speed, safety and simplicity, allowing physicians to better navigate the body's complex anatomy and deliver high power aspiration for clot removal with minimal blood loss. Additionally, 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.

"We have utilized Penumbra's aspiration technology since the introduction of the first-generation Indigo System, witnessing significant advancements with each new iteration," said Prof. Nils Kucher, Director of the Department of Angiology at the University Hospital Zurich, Switzerland .

"Our team has experience with the 12F system for acute venous thrombosis, and with this latest advancement, we are hopeful that the procedures will be even more efficient for PE and venous thrombosis as we have received positive feedback from colleagues in the U.S."

"We are eagerly anticipating the opportunity to use the new Lightning Flash 2.0 System, as it promises aspiration capabilities to address large clot burden quickly and has the potential to minimize blood loss," said Prof. Stefano Barco , Department of Angiology at the University Hospital Zurich, Switzerland .

Lightning Bolt 7 Lightning Bolt 7 is the most 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. Lightning Bolt 7 is engineered to detect the difference between blood clot and blood flow. Additionally, it is designed to break the friction between the catheter and clot by having the computer algorithms rapidly modulate aspiration to quickly fatigue the thrombus and remove the clot from the arteries. This facilitates maximum vacuum force at the catheter tip for optimal, rapid ingestion of blood clots.

"In my opinion, computer assisted thrombus removal is the future of arterial clot management and offers the promise of peak procedural efficiency that was not previously available to endovascular specialists," said Dr. Gianmarco de Donato , Chief Vascular Surgery Unit, University Hospital of Siena, Italy . "Our ability to rapidly revascularize vessels with minimal blood loss is crucial for achieving optimal patient outcomes."

Lightning Flash 2.0 and Lightning Bolt 7 come on the heels of Penumbra recently receiving CE Mark for five of its stroke reperfusion and access catheters, expanding both its neuro and vascular portfolios in Europe . These latest innovations provide physicians in Europe with a robust selection of devices to remove blood clots throughout the body.

About Penumbra Penumbra, Inc., the world's leading thrombectomy company, is focused on developing the most innovative technologies for challenging medical conditions such as ischemic stroke, venous thromboembolism such as pulmonary embolism, and acute limb ischemia. Our broad portfolio, which includes computer assisted vacuum thrombectomy (CAVT), centers on removing blood clots from head-to-toe with speed, safety and simplicity. By pioneering these innovations, we support healthcare providers, hospitals and clinics in more than 100 countries, working to improve patient outcomes and quality of life. For more information, visit www.penumbrainc.com and connect on Instagram, LinkedIn and X.

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 or other assets; 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.