The U.S. Food and Drug Administration`s (FDA) has approved the Prestige LP Cervical Disc 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. The Prestige LP Disc is designed to allow motion in the neck at the operated levels, unlike a fusion surgery that does not preserve motion.
The Prestige LP Disc is Medtronic`s third clinically-proven artificial cervical disc and its first to be determined safe and effective for both one- and two-level procedures. Additionally, it is the first artificial disc on the U.S. market to be proven statistically superior in overall success for both one- and two-level procedures.
Two pivotal clinical trials – a single-level and a two-level trial – were conducted to support the safety, effectiveness and FDA approval of the Prestige LP Disc. The two-level clinical trial included 397 patients (209 investigational and 188 control patients) at 30 sites around the U.S. At 24 months, the Prestige LP patient group demonstrated statistical superiority in overall success compared to patients treated with a two-level anterior cervical discectomy and fusion (ACDF). Overall success required a patient to meet all criteria for neurologic success, Neck Disability Index success, absence of serious, device-related adverse events, and absence of secondary surgeries at the treated levels. Overall success rates at 24 months were 81.4 percent in the investigational group and 69.4 percent in the control group. The posterior probability of superiority of the investigation group over the control group was 99.3 percent.
The low profile Prestige LP Disc has a ball-and-trough design and moves in a range of motions, including bending, rotation, and translation. The disc is made of titanium ceramic composite which provides improved wear resistance in combination with the mechanical, biocompatible, and imaging properties of the base titanium alloy. The device is MRI conditional at 1.5 and 3.0 Tesla and is now available in a smaller 5mm height.