FDA approves two spine devices


The FDA has approved Spinal USA’s two spinal treatment products, the VAULT Stand Alone ALIF System and the S-Lok PC Posterior Cervical System (pictured, right).

Rich Dickerson, Senior Vice President of Operations for Spinal USA, said that the two medical devices “provide our customers with a wider array of surgical options”.

The VAULT System (pictured, below) is designed for use with autogenous bone graft for intervertebral body fusion of the spine in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis, aiming to “reduce surgical trauma and yield a net cost saving”, said Mr Dickerson.

He added that the S-Lok PC Posterior Cervical System offers “surgeons a comprehensive fixation system with enhanced ease of use and greater intraoperative flexibility”, indicated to promote fusion of the cervical and thoracic spine in mature patients in the treatment of DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, and revision of previous cervical spine surgery and tumours.

 DDD is characterised by back pain caused by the degeneration of the disc. Spondylolithesis is a condition in which a bone in the lower part of the spine slips out of place.

Cervical spine surgery is intended to restore nerve function, stop or prevent abnormal motion in the spine, and relieve pain, numbness, tingling and weakness.

Mississippi-based Spinal USA provides spine products for the treatment of serious medical conditions, aiming to reduce medical costs.