Cerapedics’ PearlMatrix P-15 peptide enhanced bone graft for lumbar spinal fusion earned FDA premarket approval, the company said June 23.
The FDA granted it a Class III drug-device combination product for single-level transforaminal lumbar interbody fusion in adults for degenerative disc disease, according to a news release. PearlMatrix P-15 is the only bone graft of its kind proven to accelerate bone growth in lumbar fusions.
In a U.S. trial the bone graft was found to have substantially higher fusion rates at 24 months and more than twice as many patients fused at six months compared to a local autograft.
