The FDA gave ZimVie's Mobi-C cervical disc hybrid investigational device exemption, the devicemaker said Sept. 26.
The approval paves the way for ZimVie to enroll U.S. patients in a study that will assess cervical disc replacement adjacent to a spinal fusion, according to a news release. Participants will recieves simultaneous cervical disc replacement and anterior cervical discectomy and fusion between levels C3 and C7.
Mobi-C has low-profile endplates that don't need keel cuts or additional hardware, making adjacent spinal fusions possible.
"The FDA approval of the IDE application will allow us to move forward with this important study," Kee Kim, MD, a spine surgeon investigator with the study said in the release. "Good clinical data is an important step in broadening the approved indications for cervical disc replacement in hybrid constructs with fusion at an adjacent level. I am delighted to be part of this groundbreaking study, which may ultimately lead to more patients gaining access to the most appropriate treatment."
Enrollment for the trial wil take place over the coming months, and the study will span five years.