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.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.