Medtronic Presents Results of 7-year Study on 2-level Prestige LP Cervical Disc

By Julie A. Vetalice

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.

 

Product Labels: Cervical Spine, Spine Artificial Disc

Tags: Trial/Study