Centinel Spine Achieves FDA Approval for Two-Level Cervical Disc Replacement with Record-Breaking Clinical Success Rate
核心洞察
Centinel Spine (搜索) received FDA approval for two-level indications of its prodisc C Vivo (搜索) and prodisc C SK (搜索) cervical total disc replacement devices, making it the first system with two different devices approved for both one- and two-level use.
The landmark IDE clinical study demonstrated an 87.1% overall composite clinical success rate at two levels, the highest reported among all approved cervical TDR devices.
Since receiving initial FDA approval in July 2022, nearly 20,000 prodisc C Vivo (搜索) and prodisc C SK (搜索) spinal levels have been implanted by over 1,100 surgeons in the United States.
Centinel Spine (搜索) has received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for two-level indications of its prodisc C Vivo (搜索) and prodisc C SK (搜索) cervical total disc replacement (TDR) devices, marking a significant advancement in motion-preserving spine surgery. The approval makes Centinel Spine's prodisc technology the only TDR solution in the U.S. approved for one- and two-level use in both the cervical and lumbar spine (搜索).
Landmark Clinical Trial Results
The FDA approval was supported by a comprehensive IDE clinical study that enrolled 480 subjects across 31 centers, with the PMA based on analysis of 433 subjects—the highest number of subjects used to support a PMA for any cervical TDR device on the market. This landmark study was the first of its kind to evaluate two investigational TDR devices and the first PMA based on an IDE clinical study that compares an investigational system to a PMA-approved cervical TDR device.
The clinical trial demonstrated exceptional outcomes for patients treated with prodisc C Vivo (搜索) and prodisc C SK (搜索) devices. At the 24-month endpoint, patients achieved an overall composite clinical success rate of 87.1% compared to 83.7% for the control cervical TDR device. This represents the highest overall composite clinical success rate at two levels compared to any other approved cervical TDR device.
Additional key findings from the study showed that 93.9% of prodisc patients achieved a meaningful 15-point improvement in Neck Disability Index (NDI) versus 90.1% for the control device. Furthermore, 96.9% of prodisc patients had no secondary surgical interventions at the index levels, compared to 95.7% for the control group.
Clinical Impact and Surgeon Perspectives
"It's an exceptional day for cervical arthroplasty!" commented Dr. Armen Khachatryan, Orthopedic Spine Surgeon at The Disc Replacement Center in Salt Lake City, Utah. "I am particularly enthusiastic about integrating the distinct endplate configurations of the prodisc devices into my clinical practice. This approval expands the range of treatment options available to patients and underscores the continuous evolution and refinement of motion-preserving surgical techniques for cervical spine disorders (搜索)."
Dr. Jad Khalil, Orthopedic Spine Surgeon with Michigan Orthopaedic Surgeons, emphasized the clinical significance: "What sets the prodisc C Vivo (搜索) and prodisc C SK (搜索) system apart is the ability to match the implant to the patient anatomy for a more tailored approach to the procedure. We are excited to see the release of the expanded indications for this system."
Device Technology and Design
The prodisc C Vivo (搜索) and prodisc C SK (搜索) devices represent advanced cervical TDR technology with distinct design features. The prodisc C Vivo offers keel-less insertion and combines a unique anatomically-designed superior endplate with lateral spikes to optimize fit and provide immediate fixation. The prodisc C SK device features a flat endplate designed for optimized implant positioning with a low-profile central keel that offers immediate fixation and enables a streamlined keel preparation technique.
Both devices incorporate prodisc CORE technology, which has been the foundation for predictable clinical outcomes across more than 275,000 implantations worldwide over 35 years. The prodisc C Vivo (搜索) has been in clinical use internationally since 2009 and is currently one of the most frequently implanted TDR devices globally.
Market Adoption and Regulatory Achievement
Since receiving FDA approval for one-level indications in July 2022, nearly 20,000 prodisc C Vivo (搜索) and prodisc C SK (搜索) spinal levels have been implanted in the United States by over 1,100 surgeons. The company has also achieved EU Medical Device Regulation (MDR) certification for its prodisc C Vivo and prodisc C Nova (搜索) devices, ensuring compliance with the highest European standards of quality, safety, and performance.
"This is a historic milestone for Centinel Spine (搜索) and further advances treatment options for spine surgeons and their patients," stated Steve Murray, CEO of Centinel Spine. "The IDE trial supporting this FDA approval is a landmark study using another FDA-approved disc device as a control and including two different investigational devices that could be used for the same patient. This 2-level approval advances the concept of uniquely matching the disc to each level of the patient's cervical spine (搜索) and is a major step forward in total disc replacement."
The prodisc C Vivo (搜索) and prodisc C SK (搜索) devices are now indicated for reconstruction of a vertebral disc from C3-C7 following discectomy at one level or two contiguous levels, providing surgeons with expanded treatment options for patients with cervical spine disorders (搜索).