icotec Receives FDA Approval for BlackArmor® Implants in Spinal Infection Treatment

icotec Gains FDA Approval for BlackArmor® Implants

EAST HARTFORD, Conn., January 14, 2025 – icotec is excited to share that it has officially received FDA clearance to use its BlackArmor® implants for treating de novo spinal infections. This milestone makes icotec the first and only company in the United States that has secured a 510(k) approval for spinal stabilization in the case of such infections, including discitis, osteomyelitis, pyogenic infection of the intervertebral disc, and other spondyloarthritis diseases.

Chris Eigenmann, CEO of icotec Medical US, comments, "Annually, more than 15,000 patients in the United States undergo spinal stabilization due to an infection. It is both a great opportunity and a privilege to assist these patients with an implant designed for improved post-operative monitoring and visualization."

In addition to the FDA approval, icotec has achieved a Breakthrough Device Designation (BDD) for the entire BlackArmor® spinal stabilization portfolio. This recognition underscores the significant unmet medical need and the innovative advantages that BlackArmor® technology can bring to these patients.

Moreover, in line with the FDA’s decision, the Centers for Medicare and Medicaid Services (CMS) have authorized the BlackArmor® implants for the New Technology Add-on Payment (NTAP). This payment provision is available for innovative medical technologies deemed to significantly enhance the diagnosis or treatment for Medicare beneficiaries.

Clinical Value and Research

The BlackArmor® implants offer a reduction in artifacts due to a carbon/PEEK radiolucent material, enhancing postoperative imaging and infection management. Additional clinical studies, such as those led by Burkhardt et al. (2021), have demonstrated that the safety and complication rates of these implants are comparable to traditional titanium implants while providing superior imaging quality. "With the clinical data amassed in Germany over recent years, we can now provide patients with spinal infections in the United States a specialized implantation option that has proven effective," adds Roger Stadler, Group CEO. He further clarifies, "We are honored that the FDA has acknowledged the potential of carbon fiber implants for this patient population and granted the Breakthrough Device Designation based on the clinical evidence available."

More studies are set to confirm the efficacy and safety of BlackArmor® implants in addressing spinal infections.

NTAP and FDA Recognition

Starting on October 1, 2024, hospitals will be eligible for additional payments for the VADER® pedicle screw system of up to $28,000 for Medicare fee-for-service patients. The NTAP designation reflects the innovative nature and clinical value of icotec’s products, affirming its commitment to advancing care standards for spinal infection patients.

About icotec

icotec is a leading company in the treatment of tumors and spinal infections through cutting-edge implant technology. The BlackArmor® Carbon/PEEK implants integrate advanced technology with industry expertise to deliver innovative and reliable solutions for spinal surgeons and their patients. The company is dedicated to elevating the field of spinal implantation, supported by clinical successes and a commitment to innovation. The comprehensive product portfolio has received FDA clearance and is endorsed by numerous opinion leaders and cancer therapy centers worldwide. For further details, visit icotec-medical.com.

For more information or inquiries regarding this new indication, please contact John Clough, Vice President of Global Marketing and New Indications at [email protected]