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Penumbra Introduces the Ruby® XL System - the Longest, Largest, and Softest Coil on the Market for Vascular Embolization

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Penumbra (NYSE: PEN) has received FDA clearance and launched the Ruby XL System, introducing the market's longest, largest, and softest coil for vascular embolization. The system features three innovative technologies: Ruby XL, POD XL, and Packing Coil XL, all deliverable through a 0.035"+ diagnostic catheter. These coils offer unprecedented volume (up to 40mm size) and extended lengths up to 70 cm, with a primary diameter of .030". The Ruby XL System aims to enhance procedural efficiency, potentially reduce radiation exposure, and optimize outcomes in large vessel and high-flow embolization procedures. The technology includes specialized features like 3D complex shapes for aneurysm framing, hybrid multistage design for targeted vessel control, and innovative liquid metal wave shape technology for dynamic vessel adaptation.
Penumbra (NYSE: PEN) ha ottenuto l'approvazione dalla FDA e ha lanciato il sistema Ruby XL, introducendo sul mercato la bobina più lunga, più grande e più morbida per l'embolizzazione vascolare. Il sistema integra tre tecnologie innovative: Ruby XL, POD XL e Packing Coil XL, tutte utilizzabili tramite un catetere diagnostico da 0,035"+. Queste bobine offrono un volume senza precedenti (fino a 40 mm di dimensione) e lunghezze estese fino a 70 cm, con un diametro primario di 0,030". Il sistema Ruby XL è progettato per migliorare l'efficienza procedurale, ridurre potenzialmente l'esposizione alle radiazioni e ottimizzare i risultati nelle procedure di embolizzazione di grandi vasi e ad alto flusso. La tecnologia include caratteristiche specializzate come forme 3D complesse per l'inquadramento degli aneurismi, un design ibrido multistadio per il controllo mirato dei vasi e una innovativa tecnologia a forma d'onda in metallo liquido per un adattamento dinamico dei vasi.
Penumbra (NYSE: PEN) ha recibido la aprobación de la FDA y ha lanzado el Sistema Ruby XL, introduciendo en el mercado la bobina más larga, grande y suave para embolización vascular. El sistema cuenta con tres tecnologías innovadoras: Ruby XL, POD XL y Packing Coil XL, todas compatibles con un catéter diagnóstico de 0,035"+. Estas bobinas ofrecen un volumen sin precedentes (hasta 40 mm de tamaño) y longitudes extendidas de hasta 70 cm, con un diámetro primario de 0,030". El Sistema Ruby XL está diseñado para mejorar la eficiencia del procedimiento, reducir potencialmente la exposición a la radiación y optimizar los resultados en procedimientos de embolización de vasos grandes y de alto flujo. La tecnología incluye características especializadas como formas complejas en 3D para el enmarcado de aneurismas, diseño híbrido multietapa para control dirigido del vaso y una innovadora tecnología de forma de onda de metal líquido para una adaptación dinámica del vaso.
Penumbra (NYSE: PEN)는 FDA 승인을 받고 Ruby XL 시스템을 출시하여 혈관 색전술용으로 시장에서 가장 길고 크며 부드러운 코일을 선보였습니다. 이 시스템은 Ruby XL, POD XL, Packing Coil XL의 세 가지 혁신 기술을 특징으로 하며 모두 0.035" 이상의 진단 카테터를 통해 전달할 수 있습니다. 이 코일들은 최대 40mm 크기의 전례 없는 부피와 최대 70cm의 길이를 제공하며, 기본 직경은 0.030"입니다. Ruby XL 시스템은 시술 효율성을 향상시키고 방사선 노출을 줄이며 대혈관 및 고유량 색전술 절차에서 최적의 결과를 도모하는 것을 목표로 합니다. 이 기술은 동맥류 프레이밍을 위한 3D 복잡한 형태, 목표 혈관 제어를 위한 하이브리드 다단계 설계, 동적 혈관 적응을 위한 혁신적인 액체 금속 웨이브 형태 기술과 같은 특수 기능을 포함합니다.
Penumbra (NYSE : PEN) a obtenu l'autorisation de la FDA et a lancé le système Ruby XL, introduisant sur le marché la bobine la plus longue, la plus grande et la plus souple pour l'embolisation vasculaire. Le système intègre trois technologies innovantes : Ruby XL, POD XL et Packing Coil XL, toutes utilisables via un cathéter diagnostique de 0,035"+. Ces bobines offrent un volume sans précédent (jusqu'à 40 mm de taille) et des longueurs étendues jusqu'à 70 cm, avec un diamètre primaire de 0,030". Le système Ruby XL vise à améliorer l'efficacité des procédures, à réduire potentiellement l'exposition aux radiations et à optimiser les résultats lors des procédures d'embolisation des gros vaisseaux et à haut débit. La technologie comprend des caractéristiques spécialisées telles que des formes complexes en 3D pour le cadrage des anévrismes, un design hybride multi-étapes pour un contrôle ciblé des vaisseaux, et une technologie innovante de forme d'onde en métal liquide pour une adaptation dynamique des vaisseaux.
Penumbra (NYSE: PEN) hat die FDA-Zulassung erhalten und das Ruby XL System eingeführt, das die längste, größte und weichste Spule für die vaskuläre Embolisation auf dem Markt präsentiert. Das System verfügt über drei innovative Technologien: Ruby XL, POD XL und Packing Coil XL, die alle durch einen diagnostischen Katheter von 0,035"+ geliefert werden können. Diese Spulen bieten ein beispielloses Volumen (bis zu 40 mm Größe) und verlängerte Längen von bis zu 70 cm bei einem Primärdurchmesser von 0,030". Das Ruby XL System zielt darauf ab, die Verfahrenseffizienz zu verbessern, die Strahlenbelastung potenziell zu reduzieren und die Ergebnisse bei Embolisationen großer Gefäße und mit hohem Durchfluss zu optimieren. Die Technologie umfasst spezialisierte Merkmale wie 3D-komplexe Formen zur Aneurysmarahmung, ein hybrides Mehrstufendesign für gezielte Gefäßkontrolle und eine innovative Flüssigmetall-Wellenform-Technologie für dynamische Gefäßanpassung.
Positive
  • FDA clearance received for innovative Ruby XL System with unique market positioning
  • System offers highest volume per coil in the market, potentially leading to cost savings
  • Enhanced procedural efficiency may reduce radiation exposure for better patient outcomes
  • Expands Penumbra's product portfolio with three new technologies for various clinical applications
Negative
  • None.

Insights

Penumbra's FDA-cleared Ruby XL System brings advanced coil technology that could increase procedure efficiency and capture market share in vascular embolization.

Penumbra's FDA clearance for the Ruby® XL System represents a significant advancement in embolization technology. The system introduces coils with exceptional specifications - being the longest (up to 70 cm), largest (up to 40mm), and softest on the market. This innovation directly addresses key clinical challenges in vascular embolization procedures.

The Ruby XL System's ability to deliver more volume per coil could translate to fewer coils needed per procedure, potentially reducing both procedure time and radiation exposure - critical factors for patient safety and hospital efficiency. The system's compatibility with standard 0.035"+ diagnostic catheters also means hospitals won't need to purchase specialized delivery equipment.

The portfolio expansion includes three distinct technologies (Ruby XL, POD® XL, and Packing Coil XL), each with unique designs for specific clinical applications. The 3D complex shape of Ruby XL for aneurysm framing, the three-in-one occlusion technology of POD XL for high-flow vessels, and the liquid metal wave shape of Packing Coil XL show thoughtful engineering for various clinical scenarios.

Most notably, the potential for cost savings mentioned by the company's Interventional Business President suggests Penumbra is positioning this product not just as a clinical improvement but as an economic solution in the increasingly cost-conscious healthcare environment. This dual value proposition could accelerate adoption among both physicians and hospital administrators who influence purchasing decisions.

ALAMEDA, Calif., June 5, 2025 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN) announced the U.S. Food and Drug Administration (FDA) clearance and launch of the Ruby® XL System, the longest, largest and softest coil on the marketi. The Ruby XL System is designed to help physicians achieve more efficient embolization, potentially reducing radiation exposure, and optimizing outcomes — especially in large vessel and high-flow embolizationii.

"We've engineered Ruby XL to deliver more volume per coil than any other coil on the market, which may result in cost savings," said Shruthi Narayan, President of Interventional Business at Penumbra, Inc. "Ruby XL embodies Penumbra's commitment to innovation, delivering mechanical occlusion through more volume without sacrificing softness or deliverability."

The Ruby XL System introduces three unique technologies — Ruby XL, POD® XL, and Packing Coil XL — all of which can be delivered through a 0.035"+ diagnostic catheter. They have a primary diameter of .030" and are designed for procedural efficiency. These coils offer more volume (up to 40mm in size) and are available in extended lengths up to 70 cm.

  • Engineered with a 3D complex shape, Ruby XL coil is designed to frame aneurysms in a variety of clinical applications.
  • POD XL features a hybrid, multistage design and is engineered with three-in-one coil occlusion technology — an anchoring segment, a framing segment, and a dense filling segment. Designed for high flow vessels, POD XL offers smooth delivery and targeted vessel control.
  • Packing Coil XL features an innovative liquid metal wave shape technology, which is designed to adjust dynamically to the size of any vessel (up to 70 cm length).

Penumbra's Ruby portfolio of peripheral embolization products, now with Ruby XL System, provides physicians with one of the most expansive embolization offerings, enabling physicians to have the latest coil technologies and most extensive options for every case. For more information, please visit www.penumbrainc.com/products/ruby-xl.

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 InstagramLinkedIn and X.

Important Safety Information
Additional information about Penumbra's products can be located on Penumbra's website at https://www.penumbrainc.com/providers. Caution: Federal (USA) law restrictions these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Please visit www.peninc.info/risk for the complete IFU Summary Statements.

The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.

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, 2024 filed with the SEC on February 18, 2025. 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 Data as of May 2025, Ruby XL System is the largest and longest detachable embolization coil commercially available and the only 035 packing coil commercially available.

ii Ruby XL is 2X larger than Ruby 020 coils and 3X larger than conventional 035 coils. Fewer coils used may potentially lead to reduced radiation exposure.

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/penumbra-introduces-the-ruby-xl-system--the-longest-largest-and-softest-coil-on-the-market-for-vascular-embolization-302473772.html

SOURCE Penumbra, Inc.

FAQ

What are the key features of Penumbra's (PEN) Ruby XL System?

The Ruby XL System features the market's longest, largest, and softest coil for vascular embolization, with coils up to 40mm in size and 70cm in length, deliverable through a 0.035"+ diagnostic catheter.

What is the significance of FDA clearance for Penumbra's (PEN) Ruby XL System?

The FDA clearance allows Penumbra to market the Ruby XL System in the US, offering physicians enhanced efficiency in embolization procedures with potential cost savings and reduced radiation exposure.

How does the Ruby XL System benefit medical procedures?

The system improves procedural efficiency, potentially reduces radiation exposure, and optimizes outcomes in large vessel and high-flow embolization, offering more volume per coil than other market options.

What are the three technologies included in Penumbra's Ruby XL System?

The system includes Ruby XL with 3D complex shape for aneurysm framing, POD XL with hybrid multistage design, and Packing Coil XL with liquid metal wave shape technology.

What is the delivery mechanism for Penumbra's Ruby XL System coils?

All three technologies in the Ruby XL System can be delivered through a 0.035"+ diagnostic catheter with a primary diameter of .030".
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