The US Food and Drug (FDA) has granted premarket approval (PMA ) to Globus Medical ‘s articulating intervertebral disc replacement device, designed for patients with intractable symptomatic cervical disc disease (SCDD) between cervical vertebra C3 and C7.
The SECURE-C cervical artificial disc, which incorporates cobalt-chrome endplates and a central polyethylene core, is designed to provide motion similar to that of the natural cervical spine.
The PMA application included positive results from a 380-patient prospective, randomised IDE study, which is designed to compare the safety and effectiveness of SECURE-C to anterior cervical discectomy and fusion (ACDF) using a cervical plate and structural allograft.
At distinct intervals up to 24 months, patients were evaluated pre, intra and post-operatively.
Bayesian statistical methods were also used to obtain the posterior probabilities of non-inferiority and superiority.
The results demonstrated that the device is statistically superior to ACDF in terms of overall success, subsequent surgery at the index level, patient satisfaction at 24 months as well as device-related adverse events.
In addition, the rate of adjacent level surgery was numerically lower for SECURE-C than ACDF, according to the company.
Globus Medical regulatory and clinical affairs vice president Kelly Baker said; "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."
Globus Medical emerging technologies product development vice president Michael Boyer said 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," Boyer said.