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Penumbra Launches Lightning Flash 2.0 - Latest CAVT Technology Designed to Rapidly Remove Blood Clots

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Penumbra, Inc. launches Lightning Flash 2.0, a cutting-edge computer-assisted vacuum thrombectomy system designed to remove blood clots efficiently and treat pulmonary emboli. The new technology aims to improve patient safety, enhance outcomes, and streamline efficiency for physicians. Lightning Flash 2.0 features advanced algorithms for increased speed and sensitivity to thrombus and blood flow, along with audio-visual feedback for better procedure understanding. Penumbra's commitment to innovation in thrombectomy underscores their dedication to advancing patient care.
Penumbra, Inc. lancia Lightning Flash 2.0, un sistema innovativo di trombectomia assistita da computer, progettato per rimuovere efficacemente i coaguli di sangue e trattare gli emboli polmonari. La nuova tecnologia mira a migliorare la sicurezza dei pazienti, ottimizzare i risultati e aumentare l'efficienza per i medici. Lightning Flash 2.0 offre algoritmi avanzati per una maggiore velocità e sensibilità alla formazione di trombi e al flusso sanguigno, oltre a feedback audio-visivo per una migliore comprensione della procedura. L'impegno di Penumbra verso l'innovazione nella trombectomia sottolinea la loro dedizione nel progredire la cura dei pazienti.
Penumbra, Inc. lanza Lightning Flash 2.0, un sistema de trombectomía asistida por computadora de última generación diseñado para eliminar coágulos de sangre de manera eficiente y tratar embolias pulmonares. La nueva tecnología tiene como objetivo mejorar la seguridad del paciente, mejorar los resultados y optimizar la eficiencia para los médicos. Lightning Flash 2.0 presenta algoritmos avanzados para aumentar la velocidad y la sensibilidad al trombo y al flujo sanguíneo, junto con retroalimentación audiovisual para un mejor entendimiento del procedimiento. El compromiso de Penumbra con la innovación en la trombectomía subraya su dedicación a avanzar en el cuidado del paciente.
Penumbra, Inc.는 혈전을 효과적으로 제거하고 폐색전증을 치료하기 위해 설계된 최첨단 컴퓨터 보조 혈전 제거 시스템인 Lightning Flash 2.0을 출시합니다. 이 새로운 기술은 환자의 안전을 향상시키고, 결과를 개선하며, 의사의 효율성을 간소화하려는 목표를 가지고 있습니다. Lightning Flash 2.0은 혈전 및 혈류에 대한 민감도와 속도를 증가시키는 고급 알고리즘을 특징으로 하며 시술 이해를 돕기 위한 시각적, 청각적 피드백을 제공합니다. Penumbra의 혈전 제거 혁신에 대한 노력은 환자 치료의 발전에 대한 그들의 헌신을 강조합니다.
Penumbra, Inc. lance Lightning Flash 2.0, un système de thrombectomie assistée par ordinateur de pointe conçu pour retirer efficacement les caillots sanguins et traiter les embolies pulmonaires. La nouvelle technologie vise à améliorer la sécurité des patients, à améliorer les résultats et à simplifier l'efficacité pour les médecins. Lightning Flash 2.0 intègre des algorithmes avancés pour une plus grande vitesse et sensibilité au thrombus et au flux sanguin, accompagnés de retours audio-visuels pour une meilleure compréhension de la procédure. L'engagement de Penumbra envers l'innovation en thrombectomie souligne leur dévouement à l'avancement des soins aux patients.
Penumbra, Inc. bringt Lightning Flash 2.0 auf den Markt, ein computergestütztes Vakuum-Thrombektomiesystem der neuesten Generation, das darauf ausgelegt ist, Blutgerinnsel effizient zu entfernen und Lungenembolien zu behandeln. Die neue Technologie zielt darauf ab, die Sicherheit der Patienten zu verbessern, die Ergebnisse zu optimieren und die Effizienz für Ärzte zu steigern. Lightning Flash 2.0 verfügt über fortschrittliche Algorithmen, die die Geschwindigkeit und Empfindlichkeit gegenüber Thromben und Blutfluss erhöhen, sowie über audiovisuelles Feedback, das ein besseres Verständnis des Verfahrens ermöglicht. Penumbras Engagement für Innovation in der Thrombektomie unterstreicht ihre Hingabe an die Weiterentwicklung der Patientenversorgung.
Positive
  • Lightning Flash 2.0 significantly improves procedure time by shortening aspiration time and reduces blood removed during aspiration, enhancing patient safety and outcomes.
  • The new technology combines an optimally sized catheter with advanced algorithm technology for efficient blood clot removal while maintaining high safety levels.
  • Penumbra's Lightning products are the only computer-assisted mechanical thrombectomy systems available in the U.S., with early clinical data showing improved patient clinical outcomes and quality of life.
Negative
  • None.
  • Lightning Flash™ 2.0 features advanced computer assisted vacuum thrombectomy (CAVT) software, designed for increased efficiency and sensitivity to enhance removal of venous thrombus and treatment of pulmonary emboli (PE)
  • Combined with streamlined audio-visual feedback, Lightning Flash 2.0 is designed to enable physicians to restore blood flow more quickly and further minimize blood loss

ALAMEDA, Calif., April 23, 2024 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), the world's largest thrombectomy company, announced the U.S. Food and Drug Administration (FDA) clearance and launch of Lightning Flash™ 2.0, the next generation computer assisted vacuum thrombectomy (CAVT) system to remove venous thrombus and treat pulmonary emboli (PE). Lightning Flash 2.0 features advanced Lightning Flash algorithms, designed for increased speed and sensitivity to thrombus and blood flow. These new advancements combined with Penumbra's novel catheter technology allow physicians to better navigate the body's complex anatomy and deliver high power for clot removal with possible minimal blood loss.

"Based on what we've seen in the initial launch, Lightning Flash 2.0 has significantly improved procedure time by shortening the aspiration time. It has also shown reductions in blood removed during aspiration. These advantages can improve patient safety, provide better outcomes for the patients, and streamline efficiency for physicians treating the patients," said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. "As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 will provide physicians with the confidence that CAVT is a valuable frontline option." 

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. This enhanced feedback loop results in a more intuitive thrombus removal experience for the physician. 

"Lightning Flash 2.0 now combines an optimally sized catheter with the latest algorithm technology designed to more efficiently remove blood clots while maintaining a high level of safety," said Adam Elsesser, president and chief executive officer of Penumbra. "Our ongoing innovation around CAVT underscores our commitment to advancing patient care so that more patients suffering from these complicated conditions can benefit from this advanced therapy."

Lightning Flash 2.0 is part of Penumbra's Indigo® System with Lightning® portfolio. The company's Lightning products are the only computer assisted mechanical thrombectomy systems currently available in the U.S. and early clinical data has demonstrated improvement in patient clinical outcomes and quality of lifei.

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. 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 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; 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.

Contact




Jennifer Heth

Parinaz Farzin 

Penumbra, Inc

Merryman Communications

jheth@penumbrainc.com

parinaz@merrymancommunications.com

510-995-9791

310.600.6746



i Weinberg, I. Periprocedural and Patient-Reported Quality of Life Outcomes After Computer-Aided Mechanical Aspiration Thrombectomy for the Treatment of Acute Pulmonary Embolism. Presented at: VIVA 22 Oct. 31 – Nov. 3, 2022; Boston, MA. 

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SOURCE Penumbra, Inc.

FAQ

What is Penumbra, Inc.'s ticker symbol?

Penumbra, Inc.'s ticker symbol is PEN.

What is Lightning Flash 2.0?

Lightning Flash 2.0 is a cutting-edge computer-assisted vacuum thrombectomy system launched by Penumbra, Inc. designed to remove blood clots efficiently and treat pulmonary emboli.

How does Lightning Flash 2.0 improve patient safety and outcomes?

Lightning Flash 2.0 significantly improves procedure time by shortening aspiration time and reduces blood removed during aspiration, enhancing patient safety and outcomes.

What sets Lightning Flash 2.0 apart from other thrombectomy systems?

Lightning Flash 2.0 combines an optimally sized catheter with advanced algorithm technology for efficient blood clot removal while maintaining high safety levels, setting it apart from other systems.

What are Penumbra's Lightning products known for?

Penumbra's Lightning products are the only computer-assisted mechanical thrombectomy systems available in the U.S., with early clinical data showing improved patient clinical outcomes and quality of life.

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