Amedica: Regulatory Clearance for Valeo in Australia

By Julie A. Vetalice

Amedica has been granted marketing clearance in Australia for Valeo® silicon nitride ceramic interbody fusion devices.

Leadership notes that, in 1986-1988, Australian surgeons and engineers were the first to synthesize reaction-bonded silicon nitride and implant the material in lumbar spine fusion patients. Favorable outcomes were reported at 15-year follow-up.

In the U.S., at the end of 2016, the company re-filed an application with FDA for a modified cancellous-structured ceramic (CsC)-based cervical implant that is comparable to the Valeo C cervical implant.

Sources: Amedica Corporation; ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: Regulatory