The US Food and Drug Administration (FDA) has expanded the indications of Amedica’s silicon nitride interbody fusion products to include multi-level cervical treatment.
“This clearance allows Amedica to support or conduct clinical studies without the need for an IDE (Investigational Device Exemption) in two-level cervical pathologies, which can then be used to confirm the effectiveness of our silicon nitride technology platform. The clearance also allows Amedica to promote this unique point of differentiation in the marketplace,” said Sonny Bal, chairman and chief executive officer of Amedica.
“A material such as silicon nitride, which contains bone on-growth properties and participates in the fusion process, is an ideal biomaterial for implantation into the human body. This clearance also provides surgeons with a broad array of procedure options for high risk patients – patients with poor bone quality, are smokers, or who have diabetes.”
The FDA’s clearance of the expanded indications is based on data from a variety of studies and sources showing the company’s silicon nitride devices used in multi-level procedures are as safe and effective as other devices used in single level procedures. The Valeo cervical fusion devices are now indicated for use in skeletally mature patients with degenerative disc disease at one disc level or two contiguous levels. The FDA approval order allows for commercial sales and distribution of these devices for multi-level procedures.