Amedica Corporation has released the results of its CASCADE study, which compared spinal fusion surgery outcomes between the company’s spinal interbody spacers with a porous silicon nitride center and polyetheretherketone plastic spacers filled with bone autograft.
Results of the blinded, randomized clinical trial showed Amedica’s spacers provided spinal fusion surgery outcomes that were equivalent to the polyetheretherketone (PEEK) spacers, according to a company press release.
“For the first time, a porous synthetic interbody spacer with no bone or bone fillers has shown fusion rates that are equivalent to the gold standard,” Sonny Bal, MD, JD, MBA, chairman and CEO of Amedica Corporation, said in the release. “Previously, we have demonstrated that the surface topography and chemistry of our current Valeo silicon nitride spacers — sales of which were up 50% through the third quarter of 2014 as compared to the same period for 2013 — are uniquely conducive to bone ongrowth and bacterial resistance.”
One hundred four patients were enrolled in the CASCADE study, during which fusion rates and clinical outcomes were independently scored after 12 months of follow-up. Both patient groups achieved similar decreases in Neck Disability Index scores at follow-up. Cervical spine fusion rates were identical in both groups, as well.
The company is preparing a scientific paper for publication in a peer-reviewed journal that will describe the CASCADE results. Additionally, Amedica plans to submit an application in the 510(k) regulatory track this month based on the final clinical data, according to the release.