FDA Approves Medtronic's Two-Level Prestige LP Cervical Disc
BY ANDREW VAHRADIAN, JULY 25, 2016
Medtronic received clearance from the FDA for its Prestige LP Cervical Disc, indicated for the treatment of cervical disc disease causing nerve or spinal cord compression at two adjacent levels between the C3-C7 segments of the neck.
Prestige has a low profile ball-and-trough design, which allows the system to move in a range of motions, including bending, rotation, and translation. This provides the patients with a wider range of motion (ROM) for their neck than fusion surgery. The disc is made of titanium ceramic composite which imparts greater wear resistance in combination with the mechanical, biocompatible, and imaging properties of the base titanium alloy.
Medtronic provided the FDA with data from single- and two-level pivotal clinical trials. The two-level study enrolled 397 patients (209 investigational and 188 control patients) at 30 sites around the United States. At 24 months, the Prestige patient group demonstrated statistical superiority in overall success compared to patients treated with a two-level anterior cervical discectomy and fusion (ACDF). Overall success rates were 81.4% in the Prestige patient group, and 69.4% in the control group.
Prestige is Medtronic's third clinically-proven artificial cervical disc and the company's such system to be determined safe and effective for both one- and two-level procedures.
