Orthofix Medical’s M6-C Artificial Cervical Disc Receives FDA’s Approval for Cervical Disc Degeneration

 Orthofix Medical’s M6-C Artificial Cervical Disc Receives FDA’s Approval for Cervical Disc Degeneration

Orthofix Medical’s M6-C Artificial Cervical Disc Receives FDA’s Approval for Cervical Disc Degeneration

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

Click here to read full press release/ article | Ref:Orthofix Medical | Image: Ortho Spine

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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