Shots:

• The approval is based on Investigational Device Exemption (IDE) study assessing M6-C artificial cervical disc vs anterior cervical discectomy and fusion (ACDF) in patients with cervical radiculopathy with/out cord compression at between C3 to C7
• The US IDE study results @24months: 90.5% improvement in Neck Disability Index; improvement in arm & neck pain score (91.2% & 90.5% vs 77.9% & 79.9%); administration of analgesic @surgery (80.6% vs 85.7%) @24mos. (14.0% vs 38.2%); need of additional surgery (1.9% vs 4.8%)
• The M6-C artificial cervical disc is used to replace an intervertebral disc- restore physiological motion in spine- mimics the anatomical structure & capable to absorb shocks and has received EU’s CE Mark with up to 45-000 implants

Ref:Orthofix Medical | Image: Ortho Spine