Globus Medical has obtained premarket approval (PMA) from the US Food and Drug (FDA) for its 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 patients prospective, randomized 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 as well as Bayesian statistical methods were 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.
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 added.
