Penumbra Receives CE Mark for Computer Assisted Vacuum Thrombectomy Technologies - Lightning Flash™ 2.0 and Lightning Bolt™ 7 - in Europe
Penumbra, Inc. (NYSE: PEN) has received CE Mark approval in Europe for its latest computer assisted vacuum thrombectomy (CAVT) technologies – Lightning Flash™ 2.0 and Lightning Bolt™ 7. These advanced systems are designed to quickly restore blood flow by efficiently removing blood clots.
Lightning Flash 2.0, the most advanced thrombectomy system for venous and pulmonary thrombus in Europe, features dual clot detection algorithms and MaxID hypotube technology. Lightning Bolt 7, the most powerful arterial thrombectomy system, introduces modulated aspiration for rapid removal of large, fibrous blood clots in arteries.
These innovations aim to improve patient outcomes by enabling quicker procedures and more efficient clot removal while maintaining a high level of safety.
Penumbra, Inc. (NYSE: PEN) ha ricevuto l'approvazione CE in Europa per le sue ultime tecnologie di trombectomia assistita da computer (CAVT) – Lightning Flash™ 2.0 e Lightning Bolt™ 7. Questi sistemi avanzati sono progettati per ripristinare rapidamente il flusso sanguigno rimuovendo in modo efficace i coaguli di sangue.
Lightning Flash 2.0, il sistema di trombectomia più avanzato per trombi venosi e polmonari in Europa, presenta algoritmi di rilevamento dei coaguli duali e tecnologia MaxID hypotube. Lightning Bolt 7, il sistema di trombectomia arteriosa più potente, introduce aspirazione modulata per la rimozione rapida di grandi coaguli di sangue fibrosi nelle arterie.
Queste innovazioni mirano a migliorare gli esiti per i pazienti consentendo procedure più rapide e una rimozione più efficiente dei coaguli, mantenendo nel contempo un alto livello di sicurezza.
Penumbra, Inc. (NYSE: PEN) ha recibido la aprobación de la marca CE en Europa para sus últimas tecnologías de trombectomía asistida por computadora (CAVT) – Lightning Flash™ 2.0 y Lightning Bolt™ 7. Estos sistemas avanzados están diseñados para restaurar rápidamente el flujo sanguíneo mediante la eliminación eficiente de coágulos de sangre.
Lightning Flash 2.0, el sistema de trombectomía más avanzado para trombos venosos y pulmonares en Europa, cuenta con algoritmos de detección de coágulos duales y tecnología MaxID hypotube. Lightning Bolt 7, el sistema de trombectomía arterial más potente, introduce aspiración modulada para la rápida eliminación de grandes coágulos de sangre fibrosa en las arterias.
Estas innovaciones buscan mejorar los resultados en los pacientes al permitir procedimientos más rápidos y una eliminación más eficiente de los coágulos, manteniendo al mismo tiempo un alto nivel de seguridad.
Penumbra, Inc. (NYSE: PEN)는 최신 컴퓨터 보조 진공 색전증 제거(CAVT) 기술인 Lightning Flash™ 2.0와 Lightning Bolt™ 7에 대해 유럽에서 CE 마크 승인을 받았습니다. 이 고급 시스템은 혈전 제거를 통해 혈류를 신속하게 회복하도록 설계되었습니다.
Lightning Flash 2.0은 유럽에서 가장 진보된 정맥 및 폐 혈전 제거 시스템으로, 이중 혈전 탐지 알고리즘과 MaxID Hypotube 기술이 특징입니다. Lightning Bolt 7은 가장 강력한 동맥 색전증 제거 시스템으로, 동맥에서 큰 섬유성 혈전을 빠르게 제거하기 위한 조절된 흡입 방식을 도입합니다.
이러한 혁신은 안전성을 유지하면서 더 빠른 절차와 효율적인 혈전 제거를 가능하게 하여 환자 결과를 개선하는 것을 목표로 합니다.
Penumbra, Inc. (NYSE: PEN) a reçu l'approbation CE en Europe pour ses dernières technologies de thrombectomie assistée par ordinateur (CAVT) – Lightning Flash™ 2.0 et Lightning Bolt™ 7. Ces systèmes avancés sont conçus pour restaurer rapidement le flux sanguin en éliminant efficacement les caillots sanguins.
Lightning Flash 2.0, le système de thrombectomie le plus avancé pour les thrombus veineux et pulmonaires en Europe, dispose d'algorithmes de détection des caillots doubles et de la technologie MaxID hypotube. Lightning Bolt 7, le système de thrombectomie artérielle le plus puissant, introduit une aspiration modulée pour l'élimination rapide de gros caillots sanguins fibreux dans les artères.
Ces innovations visent à améliorer les résultats pour les patients en permettant des procédures plus rapides et une élimination plus efficace des caillots, tout en maintenant un niveau de sécurité élevé.
Penumbra, Inc. (NYSE: PEN) hat die CE-Kennzeichnung in Europa für seine neuesten computergestützten Vakuumthrombektomie (CAVT)-Technologien – Lightning Flash™ 2.0 und Lightning Bolt™ 7 – erhalten. Diese fortschrittlichen Systeme sind darauf ausgelegt, den Blutfluss schnell wiederherzustellen, indem sie Blutgerinnsel effizient entfernen.
Lightning Flash 2.0, das fortschrittlichste Thrombektomiesystem für venöse und pulmonale Thromben in Europa, verfügt über duale Erkennungsalgorithmen für Blutgerinnsel und MaxID-Hypotubentechnologie. Lightning Bolt 7, das leistungsstärkste arterielle Thrombektomiesystem, führt modulierte Aspiration zur schnellen Entfernung großer, faseriger Blutgerinnsel in den Arterien ein.
Diese Innovationen zielen darauf ab, die Ergebnisse für die Patienten zu verbessern, indem schnellere Verfahren und eine effizientere Entfernung von Gerinnseln ermöglicht werden, während gleichzeitig ein hohes Maß an Sicherheit gewahrt bleibt.
- Received CE Mark approval for Lightning Flash 2.0 and Lightning Bolt 7 in Europe
- Lightning Flash 2.0 is the most advanced thrombectomy system for venous and pulmonary thrombus in Europe
- Lightning Bolt 7 is the most powerful arterial thrombectomy system on the market
- New technologies designed to improve patient outcomes with quicker procedures and more efficient clot removal
- None.
Penumbra's CE Mark approval for Lightning Flash™ 2.0 and Lightning Bolt™ 7 represents a significant advancement in thrombectomy technology. These devices leverage computer-assisted vacuum thrombectomy (CAVT) with dual clot detection algorithms, potentially improving procedural efficiency and patient outcomes.
Key innovations include:
- Lightning Flash 2.0's MaxID hypotube technology, enabling a larger inner diameter with a lower profile
- Lightning Bolt 7's modulated aspiration, designed to break clot friction and enhance removal of fibrous thrombi
These advancements could lead to faster procedures, more efficient clot removal and reduced blood loss. The expansion of Penumbra's portfolio in Europe may strengthen its market position in the thrombectomy space.
The introduction of Lightning Flash 2.0 and Lightning Bolt 7 in Europe could revolutionize thrombectomy procedures. The ability to rapidly remove large clot burdens with minimal blood loss is important for conditions like pulmonary embolism (PE), venous thrombosis and acute limb ischemia (ALI).
The modulated aspiration technology in Lightning Bolt 7 is particularly intriguing for arterial thrombi, which can be more challenging to remove. This could potentially improve outcomes in ALI cases, where time to revascularization is critical.
However, it's important to note that while these devices show promise, their real-world performance and long-term outcomes will need to be closely monitored to fully assess their impact on patient care and procedural efficiency.
Penumbra's CE Mark approval for these advanced thrombectomy devices could significantly boost its market share in Europe. As the "world's leading thrombectomy company," this move further solidifies Penumbra's position in the market.
Key market implications:
- First-mover advantage with CAVT systems in Europe
- Potential for increased adoption in venous, pulmonary and arterial thrombectomy procedures
- Expanded portfolio may lead to higher sales and market penetration
The positive feedback from European physicians suggests a strong potential for market acceptance. However, the company's success will depend on effective training, support and demonstration of superior clinical outcomes compared to existing technologies.
- Latest computer assisted vacuum thrombectomy (CAVT) technologies combine superior catheter design with the latest dual clot detection computer algorithms designed to restore blood flow quickly
- Lightning Flash™ 2.0 will be the most advanced thrombectomy system on the European market to address venous and pulmonary thrombus
- Lightning Bolt™ 7 is designed to enhance the ability to rapidly remove blood clots in the arteries with modulated aspiration, addressing conditions such as acute limb ischemia (ALI), hibernating thrombus and visceral occlusions
"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
Penumbra's Lightning products will be the only CAVT systems available in
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
"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
"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
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
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
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.
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Jennifer Heth | Parinaz Farzin |
Penumbra, Inc. | Merryman Communications |
510-995-9791 | 310.600.6746 |
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FAQ
What new thrombectomy technologies has Penumbra (PEN) received CE Mark for in Europe?
What is unique about Penumbra's Lightning Flash 2.0 thrombectomy system?
How does Penumbra's Lightning Bolt 7 differ from other thrombectomy systems?
What conditions can Penumbra's new thrombectomy technologies address?
