Globus Medical Gains FDA Nod for Artificial Cervical Disc

Audubon, Pa.-based spinal implant company Globus Medical Inc. has received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its Secure-C cervical artificial disc. The approval comes following a 380-patient investigational device exemption (IDE) study, which determined that the Secure-C statistically is superior to anterior cervical discectomy and fusion (ACDF) in terms of overall success, subsequent surgery, device-related adverse events, and patient satisfaction at 24 months.

Globus designed and developed Secure-C, organized the IDE clinical study, and managed the PMA submissions.

“We are thrilled not only to receive our first PMA approval but to bring this technology to the marketplace,” said Kelly Baker, Ph.D., vice president of regulatory and clinical affairs. “The performance of Secure-C has made this PMA well worth the effort and we hope it will be a great benefit to patients.”

Added Michael Boyer, vice president of product development and emerging technologies: “Secure-C’s selectively constrained design allows a natural range of motion, including translation, while preventing dissociation.”

Secure-C is a motion-preserving alternative treatment of neck and arm pain conditions involving disc abnormalities. ACDF is the current traditional standard of care, and involves removing the damaged disc material and implanting an interbody fusion graft or spacer and a cervical plate to fuse the segment and restrict motion. Secure-C is designed to provide motion similar to that of the natural cervical spine. The implant is an articulating intervertebral disc replacement comprised of cobalt-chrome endplates and a central polyethylene core. Globus also has developed complementary specialized instrumentation intended to simplify the surgical procedure.

The prospective, randomized IDE 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 between cervical vertebra C3 and 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.

The study pinpointed the success rate of Secure-C at 90 percent, and 71 percent for ACDF. The criteria to determine success was at least a 25 percent 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. The FDA defined overall success as an NDI 15-point improvement, 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. According to these criteria, Secure-C was found to be superior.

The Secure-C cervical artificial disc treats herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes, or bone spurs), and/or visible loss of disc height as compared to adjacent levels. The device is implanted using an anterior approach, and should only be used if patients have failed at least six weeks of conservative treatment.

Photo of Secure-C courtesy of Globus Medical Inc.