Amedica's FDA 510(k)-Cleared Devices Feature Expanded Biomaterials Claims

By G.P. ThomasSep 15 2012

The data published in the journals, International Journal of Nanomedicine and Acta Biomaterialia have facilitated the expansion of biomaterials claim of the FDA 510(k)-cleared Valeo Interbody Fusion Devices developed by Amedica.

The articles elucidate the superior performance of silicon nitride-based interbody fusion devices in osteointegration and new bone formation in comparison to devices made from titanium or poly-ether-ether-ketone (PEEK). The additional benefit of these silicon nitride-based devices is their anti-infective properties. These inherent properties of Amedica’s proprietary biomaterial derived from silicon nitride form the crux of the biomaterials claim expansion. The claim expansion for Amedica’s Valeo Interbody Fusion Devices will form the basis for the development of standard of care for patients requiring spinal fusion for their back problems.

Physicians and health care providers are now aware of the properties of PEEK and titanium which have become the common source for biomaterials used in spinal devices. The studies published in the two journals describe the adverse effects of PEEK and titanium-based devices on patient outcomes. The materials have a tendency to develop a biofilm around the implant which significantly hinders bone formation. The latest changes to federal reimbursement for Medicaid and Medicare patients have strengthened the focus of the U.S. Congress on measures facilitating quality patient outcome. These developments have turned the spotlight on biomaterials for use in spinal and orthopedic implants.