icotec is proud to announce that the Company has received FDA approval for the use of BlackArmor® implants to treat de novo spinal infections.
icotec is proud to be the first and only company in the U.S. to receive FDA 510(k) clearance for spinal stabilization for de novo spinal infections, including discitis, osteomyelitis, pyogenic disc infections and other spondylopathies. ""Every year in the U.S., more than 15,000 patients are stabilized for spinal infection,"" says Chris Eigenmann , CEO of icotec Medical US, ""to be 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 on-label status, the FDA has also granted a Breakthrough Device Designation (BDD) for this indication for icotec's entire BlackArmor® spinal stabilization portfolio, recognizing the significant unmet need and novel benefits that BlackArmor® technology can provide to these patients.
Following the FDA decision, the Centers for Medicare and Medicaid Services (CMS) approved BlackArmor® for New Technology Add-on Payment (NTAP), which is awarded when innovative medical technologies significantly improve the diagnosis or treatment of Medicare beneficiaries.
Clinical Benefits and Research
icotec's BlackArmor® implants offer reduced artifacts due to the radiolucent carbon/PEEK material, allowing for improved imaging in the post-operative area and infection monitoring.
Supportive clinical studies, such as those by Burkhardt et al. (2021), have demonstrated safety with equivalent complication rates to titanium implants and shown the benefit of reduced imaging artifacts, providing additional diagnostic information for patients stabilized with carbon/PEEK implants. "Thanks to the clinical data collected in Germany over the past few years," explains Roger Stadler , CEO of the Group , "we can now offer a proven, dedicated implant option for patients with spinal infections in the United States. We are honored that the FDA has recognized the potential of carbon fiber implants for this patient population and has granted Breakthrough Device Designation based on the clinical data available." Further research to support the efficacy and safety of BlackArmor® implants in the treatment of spinal infections is ongoing.
Breakthrough Device Designation (BDD) and New Technology Add-On Payment (NTAP)
Beginning October 1 , 2024, hospitals will be 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 products, as well as the company's commitment to elevating the standard of care for patients with spinal infections.