icotec is proud to announce that it has received FDA clearance for the use of BlackArmor implants in the treatment of de novo spinal infections.
icotec is honored to be the first and only company in the United States with FDA 510(k) clearance for stabilizing the spine in de novo spinal infections, including discitis, osteomyelitis, pyogenic infection of the intervertebral disc, and other spondylopathies. “Over 15,000 patients receive spinal stabilizations due to an infection in the spine in the USA every year,” says Chris Eigenmann, CEO 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.” In addition to the on-label designation, the FDA has also granted a Breakthrough Device Designation (BDD) for this indication across the entirety of icotec’s BlackArmor® spinal stabilization portfolio in recognition of the significant unmet need and the novel benefits that BlackArmor technology may offer these patients.
Furthermore, following the FDA decision, Centers for Medicare and Medicaid Services (CMS) approved BlackArmor for New Technology Add-on Payment (NTAP), which is awarded when innovative medical technologies are determined to significantly improve the diagnosis or treatment of Medicare beneficiaries.
Clinical Value and Research
icotec’s BlackArmor implants offer reduced artifacts from radiolucent Carbon/PEEK material, which enables improved imaging in the post-operative setting as well as in the monitoring of infection.
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. “Thanks to the clinical data that was gathered in Germany over the past several years,” explains Roger Stadler, 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.” Additional research to support the efficacy and safety of BlackArmor implants in treating spinal infections is ongoing.
Breakthrough Device Designation (BDD) and New Technology Add-On Payment (NTAP)
As of October 1, 2024, hospitals are eligible to receive additional payments for the VADER pedicle screw system of up to $28,000 for Medicare Fee-for-Service patients. This NTAP designation is a testament to the innovative nature and clinical value of icotec’s products, and its commitment to advancing the standard of care for patients with spinal infections.
