FDA gives go-ahead to bone graft substitute trials.

Clinical trials can now go ahead on a biological bone graft substitute used in combination with a cage implant system for the treatment of degenerative spinal disc disease, following clearance from the US Food and Drug Administration (FDA).

The FDA granted an Investigational Device Exemption (IDE) to US companies Sulzer Spine-Tech Inc and Orquest Inc to begin trials on Orquest=s Healos product, combined with Sulzer Spine-Tech's BAK Interbody Fusion system of cage implants. The FDA letter grants approval to study Orquest's Healos product in BAK implants for the treatment of patients requiring lumbar spinal fusion at one or two levels due to the pain associated with …