FDA Expands Indications for Amedica’s Silicon Nitride Interbody Fusion Products

Salt Lake City, Utah-based Amedica Corp. reported that the U.S. Food and Drug Administration (FDA) expanded the indications of silicon nitride interbody fusion products to include multi-level cervical treatment.

“We are very pleased to become the first company to receive FDA clearance for multi-level cervical interbody cage indications,” said Sonny Bal, chairman and CEO of Amedica Corporation. “Given the high incidence of two-level cervical procedures, we are proud that our silicon nitride interbody fusion devices are now available to address two-level cervical disease. 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.”

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, according to Amedica officials. The Valeo cervical fusion devices now are 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.

“The FDA clearance reassures every surgeon and patient that scientific evidence exists that silicon nitride interbody devices can safely and effectively be used in the treatment of multi-level cervical pathologies,” said Jim A. Youssef, M.D., founder of Spine Colorado and a fellowship-trained spine surgeon. “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.”

Amedica develops medical-grade silicon nitride ceramics as well as spinal fusion products and a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty.