Globus Medical, Inc. (NYSE: GMED), today announced that the Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for the SECURE®-C Cervical Artificial Disc. Clinical data from a 380 patient investigational device exemption (IDE) study 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 design and development of SECURE®-C, as well as managing the IDE clinical study and the PMA submissions were accomplished entirely within the Globus organization. Kelly Baker, Ph.D., Vice President of Regulatory and Clinical Affairs, commented, “We are thrilled not only to receive our first PMA approval but to bring this excellent technology to the marketplace. The outstanding clinical performance of SECURE®-C has made this PMA well worth the effort and we hope it will be a great benefit to patients. I am proud of all the work accomplished with our outstanding clinical investigators and their staff, as well as our internal staff who facilitated the study.”
Michael Boyer, Vice President of Product Development, Emerging Technologies, remarked, “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 IDE study.”
SECURE®-C is a motion-preserving alternative treatment of neck and arm pain conditions involving disc abnormalities. The current traditional standard of care is anterior cervical discectomy and fusion which 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 newly approved implant is an articulating intervertebral disc replacement comprised of cobalt-chrome endplates and a central polyethylene core. Accompanying specialized instrumentation was specifically designed to simplify the surgical procedure.