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www.fdanews.com/articles/10326-fda-green-lights-medtronics-artificial-cervical-disc

FDA Green Lights Medtronic’s Artificial Cervical Disc

July 22, 2016

The FDA approved Medtronic’s Prestige LP cervical disc for treating nerve or spinal cord compression 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 the first artificial disc on the U.S. market that showed to be superior for both one- and two-level procedures in clinical trials in almost 400 patients.

The Prestige LP patient group demonstrated superiority in overall success compared to patients treated with a two-level anterior cervical discectomy and fusion. Overall success was measured by a neck disability index, absence of serious, device-related adverse events, and absence of secondary surgeries.

The Prestige LP Disc has a ball-and-trough design and allows full range of motions.