Penumbra, Inc. Announces Completion of THUNDER IDE Study Enrollment for Acute Ischemic Stroke
Penumbra, Inc. (NYSE: PEN), a leading thrombectomy company, has completed enrollment for its THUNDER clinical study evaluating the safety and efficacy of its latest computer assisted vacuum thrombectomy (CAVT™) technology for acute ischemic stroke patients. The study focuses on the Penumbra System™ with Thunderbolt™ Aspiration Tubing for removing blood clots in the brain.
The Thunderbolt technology uses an advanced CAVT software algorithm to generate modulated aspiration, aiming to reduce friction and facilitate faster, more complete clot removal. The THUNDER study (NCT05437055) is a multi-center, single-arm study involving patients with acute ischemic stroke due to intracranial large vessel occlusion (LVO) eligible for mechanical thrombectomy. The primary efficacy endpoint is the revascularization of the occluded target vessel immediately post-procedure.
Penumbra, Inc. (NYSE: PEN), un'azienda leader nel settore della trombectomia, ha completato l'arruolamento per il suo studio clinico THUNDER che valuta la sicurezza e l'efficacia della sua più recente tecnologia di trombectomia a vuoto assistita da computer (CAVT™) per pazienti con ictus ischemico acuto. Lo studio si concentra sul Penumbra System™ con Thunderbolt™ Aspiration Tubing per rimuovere i coaguli di sangue nel cervello.
La tecnologia Thunderbolt utilizza un avanzato algoritmo software CAVT per generare un'aspirazione modulata, mirata a ridurre l'attrito e facilitare la rimozione più rapida e completa dei coaguli. Lo studio THUNDER (NCT05437055) è uno studio multicentrico, a braccio singolo che coinvolge pazienti con ictus ischemico acuto dovuto a occlusione di grandi vasi intracranici (LVO) idonei per trombectomia meccanica. L'obiettivo primario di efficacia è la rivascolarizzazione del vaso target occluso immediatamente dopo la procedura.
Penumbra, Inc. (NYSE: PEN), una empresa líder en trombectomía, ha completado la inscripción para su estudio clínico THUNDER que evalúa la seguridad y eficacia de su más reciente tecnología de trombectomía por vacío asistida por computadora (CAVT™) para pacientes con accidente cerebrovascular isquémico agudo. El estudio se centra en el Sistema Penumbra™ con tubería de aspiración Thunderbolt™ para eliminar coágulos de sangre en el cerebro.
La tecnología Thunderbolt utiliza un avanzado algoritmo de software CAVT para generar aspiración modulada, con el objetivo de reducir la fricción y facilitar una eliminación de coágulos más rápida y completa. El estudio THUNDER (NCT05437055) es un estudio multicéntrico de un solo brazo que involucra pacientes con accidente cerebrovascular isquémico agudo debido a la oclusión de grandes vasos intracraneales (LVO) elegibles para trombectomía mecánica. El objetivo primario de eficacia es la revascularización del vaso objetivo ocluido inmediatamente después del procedimiento.
Penumbra, Inc. (NYSE: PEN), 선도적인 혈전제거 회사가 임상 연구 THUNDER에 대한 등록을 완료했습니다. 이 연구는 급성 허혈성 뇌졸중 환자를 위한 최신 컴퓨터 보조 진공 혈전 제거(CAVT™) 기술의 안전성과 효능을 평가합니다. 이 연구는 뇌에서 혈전 제거를 위한 Penumbra System™ 과 Thunderbolt™ 흡입 튜빙에 중점을 둡니다.
Thunderbolt 기술은 마찰을 줄이고 더 빠르고 완전한 혈전 제거를 돕기 위해 조절된 흡입을 생성하는 고급 CAVT 소프트웨어 알고리즘을 사용합니다. THUNDER 연구(NCT05437055)는 기계적 혈전 제거를 받을 수 있는 두개내 대혈관 폐쇄(LVO)로 인한 급성 허혈성 뇌졸중 환자를 포함한 다중 센터 단일 군 연구입니다. 주요 효능 지표는 시술 직후 폐쇄된 목표 혈관의 재혈관화입니다.
Penumbra, Inc. (NYSE: PEN), une entreprise leader dans le domaine de la thrombectomie, a terminé l'inscription pour son étude clinique THUNDER évaluant la sécurité et l'efficacité de sa dernière technologie de thrombectomie à vide assistée par ordinateur (CAVT™) pour les patients ayant subi un AVC ischémique aigu. L'étude se concentre sur le Système Penumbra™ avec le tube d'aspiration Thunderbolt™ pour retirer les caillots de sang dans le cerveau.
La technologie Thunderbolt utilise un algorithme logiciel CAVT avancé pour générer une aspiration modulée, visant à réduire la friction et à faciliter une élimination des caillots plus rapide et plus complète. L'étude THUNDER (NCT05437055) est une étude multicentrique à bras unique impliquant des patients ayant subi un AVC ischémique aigu en raison d'une occlusion des gros vaisseaux intracrâniens (LVO) éligibles à une thrombectomie mécanique. Le principal critère d'efficacité est la revascularisation du vaisseau cible occlus immédiatement après la procédure.
Penumbra, Inc. (NYSE: PEN), ein führendes Unternehmen in der Thrombektomie, hat die Rekrutierung für seine THUNDER-Studie abgeschlossen, die die Sicherheit und Wirksamkeit seiner neuesten computerassistierten Vakuumthrombektomie (CAVT™) Technologie bei Patienten mit akutem ischämischen Schlaganfall evaluiert. Die Studie konzentriert sich auf das Penumbra-System™ mit Thunderbolt™ Aspiration Tubing zur Entfernung von Blutgerinnseln im Gehirn.
Die Thunderbolt-Technologie nutzt einen fortschrittlichen CAVT-Softwarealgorithmus, um modulierte Aspiration zu erzeugen, mit dem Ziel, die Reibung zu reduzieren und eine schnellere sowie umfassendere Entfernung von Gerinnseln zu ermöglichen. Die THUNDER-Studie (NCT05437055) ist eine multizentrische Einzelgruppenstudie, die Patienten mit akutem ischämischen Schlaganfall aufgrund einer intrakraniellen großen Gefäßokklusion (LVO), die für eine mechanische Thrombektomie in Frage kommen, einbezieht. Der primäre Endpunkt der Wirksamkeit ist die Revaskularisierung des sofort nach der Prozedur okkludierten Zielgefäßes.
- Completion of enrollment in the THUNDER clinical study for acute ischemic stroke
- Evaluation of advanced CAVT technology for potentially improved blood clot removal
- Multi-center study design to assess efficacy and safety of the Penumbra System with Thunderbolt Aspiration Tubing
- None.
Insights
The completion of enrollment in Penumbra's THUNDER clinical study marks a significant milestone in advancing stroke treatment technology. This study evaluates the safety and efficacy of their latest Computer Assisted Vacuum Thrombectomy (CAVT™) technology, specifically the Penumbra System™ with Thunderbolt™ Aspiration Tubing.
Key points to consider:
- The study focuses on acute ischemic stroke patients with large vessel occlusion (LVO), a severe form of stroke.
- The primary endpoint is revascularization of the occluded target vessel immediately post-procedure, which is important for patient outcomes.
- Thunderbolt technology uses advanced software algorithms to generate modulated aspiration, potentially improving clot removal efficiency.
- If successful, this could represent a significant advancement in mechanical thrombectomy techniques.
While the study's completion is promising, investors should note that final results and potential FDA approval are still pending. The outcome could significantly impact Penumbra's market position in the thrombectomy space, potentially driving future revenue growth if the technology proves superior to current standards of care.
Penumbra's announcement of completed enrollment for the THUNDER study is a positive development for the company's future prospects. As the "world's leading thrombectomy company," Penumbra is reinforcing its commitment to innovation in a high-growth market segment.
Key financial implications:
- Potential market expansion: Success in this study could lead to increased adoption of Penumbra's technology, expanding their addressable market.
- Competitive advantage: The Thunderbolt technology, if proven effective, could differentiate Penumbra from competitors and potentially command premium pricing.
- Future revenue streams: A successful trial outcome could lead to new product launches, driving revenue growth in the coming years.
- R&D investment payoff: This milestone validates the company's R&D strategy and investment in advanced medical technologies.
Investors should monitor the study results closely, as positive outcomes could significantly impact Penumbra's stock performance. However, it's important to note that the full financial impact won't be realized until after study completion, data analysis and potential regulatory approvals.
"This critical milestone brings us another step closer to providing physicians with the latest technology for stroke management," said Adam Elsesser, president and chief executive officer of Penumbra. "The THUNDER study will provide the data set needed to evaluate Penumbra's Thunderbolt technology and I am optimistic that we are at the dawn of a new era in stroke treatment."
Penumbra System with Thunderbolt Aspiration Tubing uses an advanced CAVT software algorithm to generate proprietary modulated aspiration, reducing friction between the clot and reperfusion catheter and facilitating a more rapid and complete removal of blood clots in the brain. Thunderbolt Aspiration Tubing has been designed for use with Penumbra ENGINE™ and RED™ reperfusion catheters.
The THUNDER study (NCT05437055) is a multi-center, single-arm study evaluating patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy. The primary efficacy endpoint includes revascularization of the occluded target vessel at immediate post-procedure.
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. Its 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, Penumbra supports 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.
Contact | |
Jennifer Heth | Parinaz Farzin |
Penumbra, Inc. | Merryman Communications |
510-995-9791 | 310.600.6746 |
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FAQ
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