Seven-year follow-up data demonstrated favorable clinical outcomes and patient satisfaction for Medtronic's 2-level Prestige LP™ Cervical Disc vs. 2-level anterior cervical discectomy and fusion (ACDF).
The randomized, controlled, investigational device exemption trial included 397 subjects.
Key findings from statistical analysis at seven years show that 2-level Prestige LP Disc patients exhibited:
- Greater rates in overall success (78.6%) vs. 2-level ACDF (62.7%)
- Greater rates in neurological success (91.6%) vs. 2-level ACDF (82.1%)
- Greater success rates in patient-reported outcomes, including Neck Disability Index (87.0%), vs. 2-level ACDF (75.6%)
- Lower rates of second surgeries (4.2%) at index levels vs. 2-level ACDF (14.7%)
- Similar adverse event profiles to 2-level ACDF
Prestige LP is pending FDA premarket approval for 2-level use, and is the third cervical disc in Medtronic's portfolio, alongside BRYAN and Prestige ST.
Presently, LDR's Mobi-C is the only cervical disc approved for 2-level cervical disc replacement in the U.S.
Sources: Medtronic plc, ORTHOWORLD Inc.