AxioMed Freedom Total Disc Approved In Australia

By Julie A. Vetalice

AxioMed received approval from Australia's Therapeutic Goods Administration to market cervical and lumbar Freedom Viscoelastic Disc Replacement devices. Freedom is a next-generation disc replacement designed to restore natural disc height, stability and motion.

Both devices are CE Mark approved in Canada and the EU. At 2014, the cervical device had been implanted in 170 patients, while the lumbar version was implanted in 500 patients. In 2015, Axiomed announced plans to submit its Premarket Approval Application to FDA in 2016 to support a potential 2017 U.S. launch of the lumbar disc replacement.

Sources: AxioMed LLC; ORTHOWORLD Inc.; Cervical and Lumbar Artificial Disc Profiles, published 2014 - This report is complementary for ORTHOWORLD Members.

Product Labels: Spine Artificial Disc

Tags: Regulatory