Medtronic, Inc (MEMPHIS, Tennessee) announced that it has received US FDA approval to market the PRESTIGE^R Cervical Disc, the first artificial disc commercially available in the US for use in cervical disc arthroplasty or cervical artificial disc replacement. With its "ball-and-trough" design, the PRESTIGE Cervical Disc gives some patients who are suffering from cervical degenerative disc disease (DDD) with myelopathy or radiculopathy the potential for motion at the treated level and another option for pain relief and function. Typically, a traditional motion-limiting spinal fusion procedure, anterior cervical discectomy with fusion (ACDF), is indicated for these patients. In the largest clinical trial of its kind, a multicenter, prospective, and randomized clinical study assessed the safety and effectiveness of the PRESTIGE Cervical Disc on the basis of comparisons between data collected from patients with single-level symptomatic cervical DDD at one level between C3 and C7. As part of the approval conditions, the company has agreed to conduct a 7-year postapproval study to evaluate long-term safety and effectiveness and it will  also perform a 5-year enhanced surveillance study.

The study involved 541 adult patients, enrolled at 32 sites across the US, with documented DDD conditions/symptoms and associated neurologic involvement that had not responded to nonsurgical treatment for at least 6 weeks, who were randomly assigned to either the PRESTIGE Cervical Disc investigational or ACDF control groups. The investigational group of 276 patients received an anterior cervical discectomy and decompression followed by placement of the PRESTIGE Cervical Disc, and  the 265 patients in the fusion control group received an anterior cervical discectomy and decompression with the placement of an interbody ring allograft and the ATLANTIS^R Cervical Plate System (also by Medtronic).

The study found that  patients who had cervical artificial disc replacement with the PRESTIGE Cervical Disc achieved equivalence to all treatment outcome parameters and superiority in neurologic success and overall success, compared with the outcomes of patients in the ACDF treatment group. Patients in the study who received the PRESTIGE Cervical Disc were more satisfied with their surgery, returned to work sooner, achieved better neurological outcomes, and, while range of motion varied, maintained the preoperative range of motion of their neck.

At the 12-and-24-month follow-up points, the PRESTIGE Cervical Disc patient group reported a greater ability to perform their daily activities and more improvement in their neck pain than the ACDF control group; these patients also maintained sagittal (front and back) angular motion averaging more than 7° in the normal physiologic range of motion. Preoperatively, the PRESTIGE Cervical Disc group had a mean angular motion of 7.55°, which increased to an average of 7.59° at 12 and 24 months postoperatively. On average, the PRESTIGE Cervical Disc patients had a median return to work that was 16 days faster than those in the ACDF treatment group. Fewer patients in the PRESTIGE Cervical Disc group required secondary surgical procedures than those in the ACDF control group.

—A.Techman