Austin, Tex.-based LDR landed its 1st FDA approval for its Mobi-C device, a cervical disc replacement for patients with degenerative disc disease.
The privately held company, which was founded in France but is headquartered in Texas, is marketing the product as better alternative to a last-resort procedure called anterior cervical discectomy fusion, which fuses the vertebra to ease painful symptoms of a herniated disk.
LDR’s clinical trials were able to prove non-inferiority to the fusion procedure, leading the FDA to approve Mobi-C for 1-level cervical disc replacement. The implant is a bone-sparing prosthetic made of cobalt chromium alloy and polyethylene.
"The data from our study represents the latest Level I evidence supporting cervical disc replacement as an attractive treatment alternative to anterior cervical discectomy fusion for indicated patients," said CEO Christophe Lavigne in prepared remarks.