Orthovita Receives FDA Approval to Run Second Human Trial to Evaluate Cortoss Bone Filler

Orthovita have been granted an Investigational Device Exemption from the US Food and Drug Administration which will allow them to begin a second pilot trial involving humans. The trial will investigate the use of Cortoss®, a synthetic cortical bone void filler for the treatment of vertebral compression fractures using kyphoplasty treatment techniques.

Cortoss is a high strength, bone bonding, biocompatible, non-monomer eluting, self setting composite which mimics the characteristics of human bone. It consists of a terpolymer resin reinforced with combeite glass-ceramic particles. Cortoss has the ability to be able to provide immediate weight bearing capabilities.

It has the advantage over polymethylmethacrylate based bone cements, in that it does not contain volatile monomers, which can migrate throughout the host body. It also cures at a lower temperature than polymethylmethacrylate, reducing the chance of thermal tissue damage.

The kyphoplasty treatment involves using an inflatable bone tamp to reduce the fracture and create a gap into which the biomaterial can be injected, in this case Cortoss. Injecting Cortoss into the fractured vertebrae helps to stabilise and restore load bearing capabilities.

The latest study using 20 patients, will look to evaluate pain relief and improvement in function of stabilising the fractured vertebrae.

To date Cortoss has been used successfully in Europe to treat vertebral compression fractures using both the vertebroplasty and kyphoplasty techniques and has been approved for sale in Europe. A study commenced in January 2003, in the US to evaluate Cortoss applied using the vertebroplasty technique

Posted May 1^st, 2003