FDAnews Device Daily Bulletin


Sept. 7, 2005

CryoLife -- a biomaterials and biosurgical device company based in Atlanta -- announced that its BioDisc Spinal Disc Repair System, a nucleus pulposus repair device, was successfully implanted in two patients. The patients underwent a discectomy approximately six weeks ago to treat herniated discs in the lumbar spinal area.

Cryolife explained that the spinal disc is comprised of the nucleus pulposus and the surrounding fibrous tissue, known as the annulus. The nucleus pulposus is composed of a gelatinous-like material that acts as a cushion or shock absorber to the spinal column. Through either the natural process of aging or an injury, the spinal disc may weaken, resulting in a herniation. The herniation may occur adjacent to a nerve, resulting in debilitating back or leg pain. The herniation may be removed via a surgical procedure known as a discectomy, which leaves an empty void within the spinal disc. The implantation of BioDisc into this void may prevent or reduce spine instability, preserve disc height and prevent recurrent disc herniation.

CryoLife said its BioDisc implant material was easily delivered into the void space as a simple additional step at the completion of the discectomy procedure. The company added the early clinical course of both patients is proceeding as expected for such patients. These initial two patients are part of a BioDisc feasibility study being conducted in the UK. The company expects to enroll an additional eight patients in this study over the next several months.