Centinel Spine® Achieves Landmark MDR Certification Expedition
Centinel Spine® Achieves MDR Certification for Their Advanced Disc Replacement Systems
The prodisc® C Vivo and prodisc® C Nova Cervical Total Disc Replacement (TDR) devices have reached a significant milestone by obtaining certification and a CE mark under the EU Medical Device Regulation (MDR). This certification validates that these systems meet the highest European standards for quality, safety, and overall performance.
Key Features of prodisc® C Vivo and C Nova Systems
The prodisc C Vivo and prodisc C Nova Match-the-Disc™ System stands out as the first cervical TDR system providing two distinct devices that are MDR-certified. These innovations are a testament to Centinel Spine's commitment to advancing spinal care with effective solutions.
Global Usage and Proven Track Record
Introduced in 2009, the prodisc C Vivo and C Nova devices have rapidly gained favor among healthcare professionals worldwide, making them some of the most frequently used TDR systems in the global market. Their successful use underscores Centinel Spine's ability to deliver products that facilitate better patient outcomes.
MDR Certification Process and Expert Insights
Completing the stringent registration and certification process demonstrates Centinel Spine's dedication to aligning its products with the latest regulatory standards imposed by the European Union. This rigorous evaluation ensures that devices are safe and effective, providing confidence to surgeons and their patients alike.
Expert Commentary
Renowned spinal surgeon Prof. Dr. Christoph Mehren, who leads the spinal surgery department at a prominent hospital in Germany, expressed the importance of MDR approval. He emphasized, "The path to MDR approval is incredibly challenging. It’s crucial for surgeons to have continued access to reliable technologies like prodisc, which significantly improve patient care outcomes."
Company Perspective and Future Aspirations
Steve Murray, CEO of Centinel Spine, conveyed the significance of achieving MDR certification. He remarked, "This certification is a game-changer for our organization. It reflects our unwavering commitment to providing safe, high-quality products that enhance patient care globally. We aim to improve the lives of as many patients as possible through our innovative prodisc technologies. This certification is an essential leap toward that goal."
The prodisc C Vivo and C Nova systems are designed to integrate seamlessly with the human anatomy. The prodisc C Vivo features a unique design for ease of insertion and immediate fixation, while the prodisc C Nova device accommodates a flat vertebral anatomy with its tri-keel structure. Both systems leverage prodisc CORE technology, contributing to predictable clinical outcomes and demonstrating impressive performance over more than 35 years and 275,000 successful implantations globally.
About Centinel Spine, LLC
Centinel Spine®, LLC holds the distinction of being a leading global medical device company, with a specialized focus on treating cervical and lumbar spinal conditions through its innovative prodisc® technology. This technology offers a comprehensive total disc replacement (TDR) solution that is extensively researched and clinically validated through over 540 published studies, marking its unique position in the market.
For parties interested in more information about Centinel Spine and its pioneering products, the company welcomes inquiries through its official website and contact details provided below.
For further inquiries, please reach out to:
Varun Gandhi
Chief Financial Officer
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Frequently Asked Questions
What is the significance of MDR certification for Centinel Spine?
MDR certification indicates that the prodisc C Vivo and C Nova systems meet the rigorous safety and performance standards established by the EU, ensuring their quality in the medical device marketplace.
When were the prodisc devices first introduced for clinical use?
The prodisc C Vivo and C Nova devices have been clinically utilized globally since 2009.
How does the prodisc technology contribute to patient outcomes?
Prodisc technology is clinically proven, with over 540 published articles documenting its effectiveness, which allows tailored solutions based on individual patient anatomies.
What do the terms Match-the-Disc™ System refer to?
Match-the-Disc™ System signifies Centinel Spine's innovative capability to provide multiple motion-preserving solutions that accommodate different anatomical needs in cervical and lumbar TDR.
Can the public access additional information on Centinel Spine's offerings?
Yes, more information about Centinel Spine and its medical products can be found on their official website.
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