A Medical Device Daily
SpinalMotion (Mountain View, California), maker of investigational artificial discs for treating patients with degenerative disc disease, reported yesterday that it has completed enrollment of its cervical clinical trial.
The trial, evaluating the Kineflex/C cervical disc implant, is being conducted under an investigational device exemption (IDE). Enrollment in the company’s first IDE clinical trial, evaluating the Kineflex lumbar disc implant, was completed last year, it said. SpinalMotion received IDE approvals in 2005 from the FDA to commence the studies.
The cervical trial features a randomized study comparing the investigational SpinalMotion Kineflex/C cervical disc to fusion. The lumbar trial is also a randomized study comparing the investigational SpinalMotion Kineflex lumbar disc to another FDA-approved lumbar artificial disc. Both trials require a two-year follow-up period.
The lumbar disc and the cervical disc are second- generation, metal-on-metal designs intended to preserve motion and restore disc height. They feature a proprietary, straightforward implant technique that includes specialized instruments for accurate placement.
“Closing enrollment in our cervical trial is an exciting milestone for us,” said David Hovda, president/CEO of SpinalMotion. “We have enrolled almost 800 patients in our U.S. cervical and lumbar studies, and we thank our clinical centers for their tremendous support as we continue to follow these patients through completion of the trials.”