Medtronic Receives FDA Approval for 2-Level Prestige LP Cervical Disc
Medtronic affirmed the FDA approval of Prestige LP to treat cervical disc disease at two adjacent levels. Unlike fusion, Prestige LP is designed to allow motion in the neck at the operated levels.
The approval decision was filed in FDA's Premarket Approval database on 7/7/16.
Two pivotal clinical trials, single-level and two-level, were conducted to support the safety, effectiveness and FDA approval of the device. The two-level clinical trial included 397 patients (209 investigational and 188 control ) at 30 U.S. sites around the U.S. At 24 months, the Prestige group demonstrated statistical superiority in overall success vs. those treated with a two-level anterior cervical discectomy and fusion (ACDF).
The low-profile Prestige LP Disc features a ball-and-trough design with a titanium ceramic composite disc to offer improved wear resistance. It is implanted using an anterior approach.
Medtronic’s entry into the 2-level market is expected to put competitive pressure on Zimmer Biomet and Mobi-C. To date, Prestige LP and LDR's Mobi-C are the only two cervical discs approved for 2-level cervical disc replacement in the U.S. (Zimmer Biomet just recently completed its acquisition of LDR.)
Sources: Medtronic plc, ORTHOWORLD Inc.