FDA Approves SpinalMotion's Artificial Disc Implant Studies

SpinalMotion, a developer of advanced total artificial disc technology for treating patients with degenerative disc disease, has received conditional approvals from the FDA for two investigational device exemption (IDE) applications.

Under the IDEs, SpinalMotion will commence two separate clinical trials, one for its lumbar implant and one for its cervical disc implant. The lumbar trial will involve 25 U.S. sites in the first randomized study comparing two artificial discs. The investigational SpinalMotion Kineflex lumbar disc will be compared to another FDA-approved lumbar artificial disc. The cervical trial will involve 20 U.S. sites and feature a randomized study comparing the investigational SpinalMotion Kineflex-C to fusion.

Both trials are designed to demonstrate equivalent clinical success rates to their respective controls. A two-year follow-up period is required for both trials. Enrollment is expected to begin this quarter.