The FDA has approved NuVasive's Simplify cervical artificial disc for two-level total disc replacement.
The Simplify Disc, which NuVasive obtained through its $150 million acquisition of Simplify Medical, demonstrated clinical superiority at 24 months compared to anterior cervical discectomy and fusion in a two-level investigational device exemption study, according to the company.
"The Simplify Disc's clinical superiority to ACDF, coupled with its unique design properties, makes it an important tool in how spine surgeons treat cervical radiculopathy," Domagoj Coric, MD, chief of neurosurgery at Atrium Health Carolinas Medical Center in Charlotte, N.C., said in an April 6 news release.
The device is one of three artificial discs approved for two-level cervical total disc replacement.
NuVasive will showcase the Simplify Disc at the International Society for the Advancement of Spine Surgery annual meeting in Miami in May.