FDA GRANTS IDE TO LDR SPINE
Texas-based LDR Spine received an investigational device exemption (IDE) from the FDA to conduct U.S. clinical trials with their Mobi-C artificial cervical disc, the company announced.
The clinical trial, which will include 600 patients, will examine how the Mobi-C cervical disc performs in patients with degenerative disc disease of vertebrae C3 through C7, the company said. The Texas Back Institute will act as lead clinical site, with up to 20 medical centers in Texas and California. Follow-up will last two years. Patient enrollment should be completed in late 2006, the company said.
Mobi-C is a second-generation cervical disc device, which consists of the prosthetic disc, a polyethylene mobile core and an instrument used for inserting the disc into the spine. The mobile core allows for instantaneous self-centering upon insertion of the prosthetic.