FDA Gives Breakthrough Device Designation for Premia Spine’s Spinal Arthroplasty System
The FDA has granted Premia Spine a Breakthrough Device designation for its TOPS spinal arthroplasty system.
The mechanical implant replaces bony and soft tissues removed during spinal decompression surgery, a procedure used to treat narrowing of the spinal canal, slipped discs and facet-joint arthritis or cysts.
The system allows patient movement in all directions while also blocking sheer forces exerted on the lower spine. The device is clinically proven to provide immediate and sustained pain relief, the company said.