icotec has earned U.S. Food and Drug Administration (FDA) clearance to use its BlackArmor implants to treat de novo spinal infections.

This makes icotec the first, only company in the U.S. with 510(k) clearance to stabilize the spine in de novo spinal infections, including discitis, osteomyelitis, pyogenic infection of the intervertebral disc, and other spondylopathies. In addition to the on-label designation, the FDA awarded breakthrough status for this indication across the BlackArmor spinal stabilization portfolio.

Following the FDA decision, the Centers for Medicare and Medicaid Services (CMS) also approved BlackArmor for New Technology Add-on Payment (NTAP).

The company’s BlackArmor implants present reduced artifacts due to radiolucent carbon/PEEK material. This improves imaging in the post-op setting and monitoring of infection, the company said. Supporting clinical studies, such as Burkhardt et al. (2021), have demonstrated safety, with equivalent complication rates to titanium implants, and showed the benefit of reduced imaging artifact, which provides additional diagnostic information for patients stabilized with carbon/PEEK implants.

“Over 15,000 patients receive spinal stabilizations due to an infection in the spine in the USA every year,” said Chris Eigenmann, CEO of icotec Medical US. “Being able to help these patients with an implant that allows for improved post-operative monitoring and visualization is a great opportunity and privilege.” Eignenmann was appointed as the company’s U.S. CEO in February 2024.

Further research to support BlackArmor implant safety and efficacy to treat spinal infections is ongoing.

“Thanks to the clinical data that was gathered in Germany over the past several years,” said Roger Stadler, icotec group CEO, “we can now offer a proven, dedicated implant option to spinal infection patients in the United States. We feel honored that the FDA has recognized the potential of carbon fiber implants for this patient population and granted a Breakthrough Device Designation based on the clinical data available.”