The US Food and Drug Administration (FDA) has granted premarket approval to Globus Medical for its Secure-C Cervical Artificial Disc.
The approval was supported with clinical data from a 380 patient investigational device exemption study which demonstrate that Secure-C is statistically superior to anterior cervical discectomy and fusion (ACDF) in terms of overall success, subsequent surgery at the index level, device-related adverse events, and patient satisfaction at 24 months.
The Secure-C is a motion-preserving alternative treatment of neck and arm pain conditions involving disc abnormalities. The device is designed to provide motion similar to that of the natural cervical spine. The newly approved implant is an articulating intervertebral disc replacement comprised of cobalt-chrome endplates and a central polyethylene core.
“I am extremely proud of this accomplishment and believe that Secure-C exemplifies Globus’ vision, commitment, and drive in developing innovative leading solutions for patients with spinal disorders. Secure-C’s selectively constrained design allows a natural range of motion, including translation, while preventing dissociation. This approval further validates our core strengths and abilities in engineering, design and testing, which proved to be invaluable in developing this product and in its clinical success in the investigational device exemption study,” said Michael Boyer, vice president of Product Development, Emerging Technologies, Globus Medical.
Clinical study of Secure-C Cervical Artifiial Disc
The prospective, randomised study compared the safety and effectiveness of Secure-C to ACDF using a cervical plate and structural allograft for patients with intractable symptomatic cervical disc disease (SCDD) between cervical vertebra C3–C7. Patients were evaluated pre- intra- and post-operatively, at distinct intervals up to 24 months and annually thereafter. Bayesian statistical methods were used to obtain the posterior probabilities of non-inferiority and superiority.
Overall success results from the study demonstrate statistical superiority of Secure-C compared to fusion at 24 months (Randomised patients: 90.1% Secure-C vs. 71.1% ACDF). Overall success criteria were at least 25% improvement in pain and disability using the Neck Disability Index (NDI), no subsequent surgery at the index level, no device-related complications, and fusion for ACDF control at 24 months. Additional overall success criteria, as defined by FDA, were a 15 point improvement in NDI, maintenance or improvement in neurologic status, no subsequent surgery at the index level, no device-related adverse events, and no change in treatment, at 24 months, and Secure-C demonstrated statistical superiority using this criteria (Randomised patients: 83.8% Secure-C vs. 73.2% ACDF). Subsequent surgery at the index level, device-related adverse event rates, and patient satisfaction for Secure-C were also shown to be statistically superior to the control group. In addition, the rate of adjacent level surgery was numerically lower for Secure-C than ACDF.