A Medical Device Daily

Orthovita (Malvern, Pennsylvania) reported that it has completed enrollment for its prospective, randomized study for Cortoss bone augmentation material in development for the treatment of vertebral compression fractures.

The study is being conducted under an FDA investigational device exemption and is designed to assess the safety and efficacy of Cortoss for the treatment of osteoporotic vertebral compression fractures as compared to commercially available polymethylmethacrylate bone cement. The study was open to patients with an osteoporotic compression fracture at one or two levels who also had a minimum VAS score of 50, a minimum ODI score of 30%, presence of edema on MRI or bone scan and who met certain other eligibility criteria. Patients are monitored with post-operative CT scans and radiographs to assess and quantify any material extravasations.

Cortoss has CE certification for use in the European Union for screw augmentation and for vertebral augmentation.

"Pending regulatory clearance, Cortoss is positioned to be the first new, proprietary biomaterial implant for the treatment of vertebral compression fractures and an alternative to PMMA bone cements available today," said Anthony Koblish, president/CEO of the company.

Orthovita develops biomaterials and biologic technologies used in synthetic, biologically active, tissue engineering products.