Centinel Spine Achieves MDR Certification for Innovative Cervical Disc Replacement Systems

Centinel Spine Achieves Significant Milestone with MDR Certification

In a groundbreaking development for spinal surgery, Centinel Spine®, LLC, has received the European MDR (Medical Device Regulation) certification for its prodisc® C Vivo and prodisc® C Nova cervical total disc replacement systems. This recognition not only underscores the quality, safety, and performance of these devices but also highlights Centinel Spine’s dedication to providing innovative solutions for spinal health.

The prodisc C Vivo and prodisc C Nova systems are now CE-marked, adhering to the highest European standards. This certification reflects an ongoing commitment to patient care and incorporates the strictest norms for medical device regulation in Europe. With this new validation, both devices continue to enhance the options available to patients requiring cervical total disc replacement (TDR) surgery.

The prodisc C Vivo and prodisc C Nova systems have a significant history in clinical use worldwide, operating effectively since 2009. With an established presence in clinical settings, these systems are among the most frequently utilized cervical TDR technologies globally. Their use reflects a growing trend towards minimally invasive procedures that prioritize patient comfort and recovery.

Centinel Spine's journey towards securing MDR certification played a crucial role in ensuring that European surgeons maintain access to proven technologies like the prodisc series. Prof. Dr. Christoph Mehren, a leading spinal surgeon at Schön Klinik in Munich, voiced the importance of this endeavor, stating, “The path to MDR approval is extremely challenging. Centinel Spine was willing to push forward and do what was necessary to provide European surgeons with continued access to a proven life-changing technology.” This highlights the collaborative efforts needed to advance surgical options while maintaining high standards of care.

Steve Murray, CEO of Centinel Spine, remarked, “This marks a pivotal moment for us as an organization. Securing MDR certification for the prodisc C Vivo and prodisc C Nova total disc replacement devices has been complex and demanding, but it underscores our commitment to delivering safe and clinically-proven products.” His statement points to the strategic vision driving Centinel Spine, with a focus on improving the quality of life for patients worldwide.

The prodisc C Vivo device is particularly notable for its keel-less insertion design, combined with an anatomically optimized superior endplate that provides enhanced fit and immediate fixation. In contrast, the prodisc C Nova features a flat endplate, engineered to accommodate flat vertebral anatomy, and a tri-keel design for immediate stability. Both systems leverage the innovative prodisc CORE technology, which has demonstrated consistent clinical success over 35 years, with more than 275,000 implants conducted globally.

Centinel Spine’s extensive research into the prodisc technology is reflected in over 540 published studies validating its efficacy and safety. The company is dedicated to developing a comprehensive range of motion-preserving anatomical solutions, enabling surgeons to customize the TDR options to each patient's unique needs. This personalization supports optimal surgery outcomes and faster recovery times for patients.

Centinel Spine operates with the singular focus on treating cervical and lumbar spinal diseases, aiming to innovate solutions through prodisc technology. This technology is distinguished by its extensive clinical validation and is widely recognized as the leading TDR system around the world. The company's prodisc systems promote an individualized surgical approach, underscoring their commitment to addressing the specific anatomical and functional requirements of each patient.

In conclusion, the MDR certification of Centinel Spine's prodisc systems marks a significant advancement in the field of spinal surgery. It reaffirms the company’s relentless pursuit of innovation and excellence in ensuring patient safety and comfort. As more surgeons adopt these advanced modalities, patients can look forward to improved outcomes and a better quality of life.

For more information on Centinel Spine and their innovative products, please visit Centinel Spine.