Centinel Spine®, LLC, (“the Company”) a leading global medical device company addressing cervical and lumbar spinal disease through anterior surgical access, today announced the first implantation of its prodisc® C SK Cervical Total Disc Replacement (TDR) product. In July, the Company received U.S. Food and Drug Administration approval for 1-level indications for prodisc C Vivo, prodisc C SK, and prodisc C Nova. The prodisc C SK system is the second of the three new products to be released with the Company recently announcing the 100th completed procedure with its prodisc C Vivo TDR product.
Along with the currently available prodisc C implant, Centinel Spine has the broadest offering of cervical TDR solutions in the world to address individual patient anatomy and meet surgeon preference needs.
“In spine care, each patient’s circumstances are different, so it is critical to provide surgeons with the ability to address each patient’s unique needs,” said Centinel Spine CEO Steve Murray. “With the release of both the prodisc C Vivo and prodisc C SK devices, we have expanded the options available to surgeons to allow for better matching of the disc to the patient. While these two new product releases have been conducted on a limited scale, we have already seen a strong positive response from surgeon partners related to the potential patient benefits.”
The prodisc C SK device features a flat endplate design for optimized implant positioning that allows surgeons to address individual patient anatomy—and a low-profile central keel that provides immediate fixation and enables a streamlined keel preparation technique. Similar to all prodisc products, the prodisc C SK device incorporates prodisc CORE technology, the basis behind the predictable clinical outcomes of the prodisc platform after 30 years and over 225,000 implantations worldwide.*
According to orthopedic spine surgeon Ehsan Jazini, MD, from the Virginia Spine Institute in Reston, Virginia, “I am proud to be the first surgeon to use this innovative technology in the DC metro region. As a pioneer working to make disc replacement surgery ultra-customized for each patient, the prodisc C SK and prodisc C Vivo devices provide me the versatility to match the disc to the patient’s anatomy. With this advanced proven technology, we can best gain motion preservation and stability as appropriate for each cervical surgery.”
Orthopedic spine surgeon Jason Tinley, MD, founder of the DFW Center for Spinal Disorders in Dallas-Fort Worth, Texas, agrees, noting, “With prodisc C SK now FDA-approved along with prodisc C Vivo and the original prodisc C, I have the intra-operative modularity to change implant characteristics based on patient morphology. While an MRI or X-ray may appear to favor the need for a flat endplate and keels versus a superior dome shape with spikes, once your carpentry is performed, I’ve found that it’s not uncommon that the alternative option may actually offer better stability and endplate conformity upon trialing.”
* Data on file