Zimmer Biomet Receives CE Mark Approval for RibFix Advantage® Fixation System
Zimmer Biomet (NYSE: ZBH) has achieved a significant milestone with CE Mark certification for its RibFix Advantage® Fixation System, marking the first CE Mark approval for an intrathoracic rib fixation system. This innovative system is designed for thoracoscopic fixation, stabilization, and fusion of rib fractures through a minimally invasive approach.
The system features a unique Bridge component that auto-contours to reduce fractures and adapts to rib anatomy during tightening, offering potential benefits of reduced soft tissue disruption compared to traditional open reduction internal fixation. Following its success in the US and other markets, the CE Mark approval enables Zimmer Biomet to distribute the system across the European Economic Area (EEA) and other CE Mark-recognizing markets.
Zimmer Biomet (NYSE: ZBH) ha raggiunto un traguardo significativo con la certificazione CE per il suo RibFix Advantage® Fixation System, segnando la prima approvazione CE per un sistema di fissazione intratoracica delle costole. Questo sistema innovativo è progettato per la fissazione, stabilizzazione e fusione delle fratture costali attraverso un approccio minimamente invasivo.
Il sistema presenta un componente unico chiamato Bridge che si auto-modella per ridurre le fratture e si adatta all'anatomia delle costole durante il serraggio, offrendo potenziali vantaggi di ridotta interruzione dei tessuti molli rispetto alla tradizionale riduzione aperta con fissazione interna. Dopo il suo successo negli Stati Uniti e in altri mercati, l'approvazione CE consente a Zimmer Biomet di distribuire il sistema nell'Area Economica Europea (EEA) e in altri mercati che riconoscono il marchio CE.
Zimmer Biomet (NYSE: ZBH) ha alcanzado un hito significativo con la certificación CE para su RibFix Advantage® Fixation System, marcando la primera aprobación CE para un sistema de fijación intratorácica de costillas. Este sistema innovador está diseñado para la fijación, estabilización y fusión de fracturas costales a través de un enfoque mínimamente invasivo.
El sistema cuenta con un componente único llamado Bridge que se auto-modela para reducir fracturas y se adapta a la anatomía de las costillas durante el ajuste, ofreciendo potenciales beneficios de reducción de la interrupción de los tejidos blandos en comparación con la fijación interna de reducción abierta tradicional. Tras su éxito en EE. UU. y otros mercados, la aprobación CE permite a Zimmer Biomet distribuir el sistema en el Espacio Económico Europeo (EEE) y en otros mercados que reconocen el marcado CE.
Zimmer Biomet (NYSE: ZBH)는 RibFix Advantage® Fixation System에 대한 CE 마크 인증을 통해 중요한 이정표를 세웠으며, 이는 흉강 내 갈비뼈 고정 시스템에 대한 첫 번째 CE 마크 승인을 의미합니다. 이 혁신적인 시스템은 최소 침습적인 접근 방식을 통해 흉강 내 갈비뼈 골절의 고정, 안정화 및 융합을 위해 설계되었습니다.
이 시스템은 골절을 줄이기 위해 자동으로 형태를 조정하는 독특한 Bridge 구성 요소를 특징으로 하며, 조일 때 갈비뼈 해부학에 적응하여 전통적인 개방적 감축 내부 고정에 비해 연조직 파괴를 줄일 수 있는 잠재적인 이점을 제공합니다. 미국 및 기타 시장에서의 성공에 이어 CE 마크 승인은 Zimmer Biomet이 유럽 경제 지역(EEA) 및 기타 CE 마크를 인정하는 시장에서 시스템을 배포할 수 있게 합니다.
Zimmer Biomet (NYSE: ZBH) a atteint une étape importante avec la certification CE de son RibFix Advantage® Fixation System, marquant la première approbation CE pour un système de fixation intrathoracique des côtes. Ce système innovant est conçu pour la fixation, la stabilisation et la fusion des fractures costales par une approche mini-invasive.
Le système présente un composant unique appelé Bridge qui se contourne automatiquement pour réduire les fractures et s'adapte à l'anatomie des côtes lors du serrage, offrant des avantages potentiels en termes de réduction des perturbations des tissus mous par rapport à la fixation interne par réduction ouverte traditionnelle. Suite à son succès aux États-Unis et sur d'autres marchés, l'approbation CE permet à Zimmer Biomet de distribuer le système dans l'Espace économique européen (EEE) et dans d'autres marchés reconnaissant le marquage CE.
Zimmer Biomet (NYSE: ZBH) hat einen bedeutenden Meilenstein mit der CE-Kennzeichnung für sein RibFix Advantage® Fixation System erreicht, was die erste CE-Zulassung für ein intrathorakales Rippenfixationssystem markiert. Dieses innovative System ist für die thorakoskopische Fixation, Stabilisierung und Fusion von Rippenfrakturen durch einen minimalinvasiven Ansatz konzipiert.
Das System verfügt über eine einzigartige Bridge-Komponente, die sich automatisch anpasst, um Frakturen zu reduzieren, und sich während des Festziehens an die Anatomie der Rippen anpasst, was potenzielle Vorteile einer reduzierten Weichgewebeschädigung im Vergleich zur traditionellen offenen Reduktion mit interner Fixation bietet. Nach dem Erfolg in den USA und anderen Märkten ermöglicht die CE-Zulassung Zimmer Biomet, das System im Europäischen Wirtschaftsraum (EWR) und in anderen Märkten mit CE-Kennzeichnung zu vertreiben.
- First CE Mark approval in its category, expanding market access to EEA
- Successfully established presence in US and other markets before European expansion
- Innovative product offering potential clinical advantages over traditional methods
- None.
Expanding Thoracic Portfolio
WARSAW, Ind., and
The RibFix Advantage Fixation System is intended for the thoracoscopic fixation, stabilization and fusion of rib fractures1, allowing for a minimally invasive approach compared with traditional open reduction internal fixation, with the potential for less soft tissue disruption.2 3 The RibFix Advantage Bridge adapts to the anatomy of the rib during tightening and auto-contours to reduce the fracture.2 The system and surgical technique offer an innovative advancement in rib fracture management.
"Following the success of RibFix Advantage Fixation System in
With the CE Mark, Zimmer Biomet will make the RibFix Advantage Fixation System available in the European Economic Area (EEA) and other markets that recognize the CE Mark.
RibFix Advantage Fixation System
For more information on the RibFix Advantage Fixation System watch the animation.
About Zimmer Biomet
Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. We seamlessly transform the patient experience through our innovative products and suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence.
With 90+ years of trusted leadership and proven expertise, Zimmer Biomet is positioned to deliver the highest quality solutions to patients and providers. Our legacy continues to come to life today through our progressive culture of evolution and innovation.
For more information about our product portfolio, our operations in 25+ countries and sales in 100+ countries or about joining our team, visit www.zimmerbiomet.com or follow on LinkedIn at www.linkedin.com/company/zimmerbiomet or X / Twitter at www.twitter.com/zimmerbiomet.
1 Zimmer Biomet IFU 01-50-1700 EN Rev. A 2021/07
2 RibFix Advantage Surgical Technique Form. No. 01-30-1700 Rev 1 2023-07 2k2307 VV-09882
3 Tay-Lasso, E., Alaniz, L., Grant, W., Hovis, G., Frank, M., Kincaid, C., ... & Schubl, S. D. (2023). Prospective single-center paradigm shift of surgical stabilization of rib fractures with decreased length of stay and operative time with an intrathoracic approach. Journal of Trauma and Acute Care Surgery, 94(4), 567-572.
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SOURCE Zimmer Biomet Holdings, Inc.
FAQ
What is the significance of CE Mark approval for Zimmer Biomet's RibFix Advantage System?
How does the RibFix Advantage Fixation System differ from traditional rib fracture treatments?
Which markets will have access to ZBH's RibFix Advantage System following CE Mark approval?
What are the main clinical applications of Zimmer Biomet's RibFix Advantage System?
