US OKs Orthovita's vertebral fracture trial:
This article was originally published in Clinica
The US FDA has given Orthovita the green light to begin a pilot study to assess its injectable biomaterial as a treatment for vertebral compression fractures. The synthetic cortical bone void filler, called CORTOSS, will be tested in a trial involving 20 patients at four centres. A European study of the biomaterial in vertebral fractures is already underway (see Clinica No 1017, p 29). Cortoss is currently approved in Europe for the fixation of screws used in patients with weak bone caused by osteoporosis. US trials for this indication are also underway, notes the Malvern, Pennsylvania firm.