Alphatec starts clinical trial of OsseoFix
This article was originally published in Clinica
Executive Summary
Spine disorder specialist Alphatec has started a clinical trial of its OsseoFix spinal fracture reduction system. The German study, in 30 patients with vertebral compression, will evaluate the level of pain relief and vertebral stability seen with the device. The Carlsbad, California company filed OsseoFix with the US FDA last month, and hopes to receive 510(k) clearance and launch it by late 2008. OsseoFix uses less cement during a surgical procedure and reduces fractures compared with other common procedures, kyphoplasty and vertebroplasty, Alphatec says. The former involves inflating a balloon catheter in the damaged vertebrae and reinforcing the space with bone cement; while the latter directly injects cement under high pressure. According to Alphatec OsseoFix could reduce the risk of cement extravasation and reduce surgical complications.