|LDR's Mobi-C cervical disc replacement--Courtesy of LDR|
After years of development work on its Mobi-C cervical disc replacement, LDR finally won an approvable letter from the FDA in October 2012, which means the product can reach the regulatory finish line assuming certain conditions are met. That finally happened 10 months later, when regulators approved the implant for one-level cervical disc replacement to treat disc degeneration.
Made of a cobalt chromium alloy and polyethylene, Mobi-C is described as a "mobile-bearing prosthesis" that works as a cervical intervertebral disc replacement and helps spare bone.
The implant helps boost the standard of care by offering a very different alternative from the typical treatment: spinal fusion. LDR is also one of the few companies in the market to have obtained FDA approval for a cervical artificial disk implant with one-level indications.
To reach the FDA finish line, LDR relied in part on a 600-patient trial that showed Mobi-C was superior to fusion treatment.
The thing is, the FDA had determined that Mobi-C was approvable for two-level use to treat cervical degenerative disc disorder. Regulators granted an initial premarket approval for one-level use, while the two-level premarket approval application process continues.
LDR, founded in France but based in Austin, TX, has potentially quite a bit to gain, considering the rapidly aging population and the reality that many patients over age 50 face some sort of disc degeneration in their future.
LDR wins FDA approvable letter for cervical disc replacement