FDA Approves Investigational Device Exemption for Total Facet Arthroplasty System

Strategic Insights -

Spinal implant manufacturer Archus Orthopedics Inc has received an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) for its total facet arthroplasty system (TFAS), designed to treat spinal stenosis. The device, which replaces degenerative facet joints with a prosthetic joint implant, aims to restore stability and normal motion to the spine, eliminating the need for spinal fusion. This approval clears the way for Archus to begin its clinical trial in the USA, comparing TFAS to spinal fusion achieved using posterior, pedicle screw instrumentation.

Key Takeaways:

  • The FDA granted an Investigational Device Exemption (IDE) to Archus Orthopedics Inc for its total facet arthroplasty system (TFAS), allowing the company to initiate a clinical trial in the USA.
  • The TFAS is designed to treat spinal stenosis by replacing degenerative facet joints with a prosthetic joint implant, eliminating the need for spinal fusion.
  • The device has already received the CE mark and is currently available in the European market.
  • The FDA-approved clinical trial will compare TFAS to spinal fusion achieved using posterior, pedicle screw instrumentation, involving up to 20 sites in the USA.
  • Patients enrolled in the trial will be followed for two years, a standard practice in orthopaedic and spine device trials.
  • The manufacturer, Archus Orthopedics Inc, is led by Chairman Jim Fitzsimmons, who can be contacted for further information.

Statistics:

  • Number of sites for the clinical trial: up to 20
  • Trial duration: 2 years
  • Number of patients to be enrolled: Not specified
  • Number of facet joints to be replaced by the TFAS implant: Each patient's respective number
  • Percentage of patients that will undergo spinal fusion as comparator: Not specified

Sources:

*

  • ArchusOrthopedics Inc