icotec has announced that its BlackArmor implants have received FDA clearance for the treatment of de novo spinal infections. This clearance marks icotec as the first and only company in the United States with FDA 510(k) clearance for stabilizing the spine in these specific infections, including discitis, osteomyelitis, pyogenic infection of the intervertebral disc, and other spondylopathies. The BlackArmor implants are designed to offer improved post-operative monitoring and visualization, addressing a critical need in managing spinal infections.
Chris Eigenmann, CEO of icotec Medical US, stated, "Over 15,000 patients receive spinal stabilizations due to an infection in the spine in the USA every year. Being able to help these patients with an implant that allows for improved post-operative monitoring and visualization is a great opportunity and privilege."
Breakthrough Device Designation and NTAP Approval
In addition to the FDA 510(k) clearance, icotec's BlackArmor spinal stabilization portfolio has been granted a Breakthrough Device Designation (BDD). This designation recognizes the significant unmet need in treating spinal infections and the potential benefits of BlackArmor technology. Furthermore, the Centers for Medicare and Medicaid Services (CMS) has approved BlackArmor for New Technology Add-on Payment (NTAP). This NTAP status is awarded to innovative medical technologies that significantly improve the diagnosis or treatment of Medicare beneficiaries, potentially providing hospitals with additional payments up to $28,000 for Medicare Fee-for-Service patients using the VADER pedicle screw system.
Clinical Value and Research
BlackArmor implants are constructed from radiolucent Carbon/PEEK material, which reduces artifacts in postoperative imaging. This improved imaging capability aids in the monitoring of infection and the assessment of the surgical site. Clinical studies, such as the one by Burkhardt et al. (2021), have demonstrated the safety of BlackArmor implants, showing complication rates equivalent to titanium implants, with the added benefit of reduced imaging artifacts.
Roger Stadler, Group CEO, commented, "Thanks to the clinical data that was gathered in Germany over the past several years, 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."
Ongoing research continues to support the efficacy and safety of BlackArmor implants in the treatment of spinal infections, reinforcing icotec's commitment to advancing spinal care.
