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

EAST HARTFORD, Conn., January 14, 2025 /PRNewswire/ — icotec is thrilled to announce that it has received authorization from the FDA for the use of its BlackArmor® implants in managing de novo spinal infections. This landmark achievement marks icotec as the first and only company in the United States to secure a 510(k) FDA approval aimed at stabilizing the spine for various spinal infections like discitis, osteomyelitis, pyogenic disc infections, and other spondyloarthropathies.

Chris Eigenmann, CEO of icotec Medical US, emphasized the significant impact this technology could have, stating, "Over 15,000 patients in the United States require spinal stabilizations due to infections each year. Having the opportunity to assist these patients with an implant that enhances monitoring and visualization post-surgery is a remarkable privilege.”

Apart from receiving this critical label designation, the FDA has also granted the BlackArmor® range of spinal stabilization implants, including the latest innovation, an Innovative Device Designation (BDD). This accolade is bestowed upon medical technologies that fulfill an unmet clinical need and offer new advantages to patients.

Following the FDA's endorsement, the Centers for Medicare and Medicaid Services (CMS) approved BlackArmor® for New Technology Add-On Payment (NTAP) starting October 1, 2024. This financial support is vital for hospitals, enabling them to receive additional payments of up to $28,000 for treating patients under Medicare who use the innovative screw system, VADER®. This not only underscores the inventive essence of icotec’s products but also affirms the commitment to enhancing patient treatment standards in spinal infection cases.

Clinical Value and Research

icotec's BlackArmor® implants offer greatly reduced artifacts thanks to their carbon/PEEK radiolucent material, allowing for superior postoperative imaging and infection monitoring. Supporting clinical studies, such as one conducted by Burkhardt et al. (2021), have demonstrated comparable safety profiles to titanium implants, while also providing reduced imaging artifacts that yield additional diagnostic insights for patients receiving stabilization with the carbon/PEEK implants.

Roger Stadler, Group CEO, explained, "Thanks to the clinical data gathered in Germany over the past years, we can now offer a tested implant option specifically tailored for patients with spinal infections in the United States. It's an honor that the FDA has recognized the potential of fiber-reinforced carbon implants for this patient population and has granted an Innovative Device Designation based on the available clinical data.” Furthermore, ongoing research efforts continue to bolster the efficacy and safety of BlackArmor® implants in treating spinal infections.

Innovative Device Designation (BDD) and NTAP

With the NTAP designation, icotec demonstrates its commitment to innovation and clinical value for its products. The backing from CMS signals confidence in their effectiveness and the progressive changes they can inspire in spinal surgery protocols.

About icotec

icotec stands at the forefront of addressing tumors and infections of the spine through the development of next-generation high-tech implants. With its BlackArmor® Carbon/PEEK solutions, icotec merges cutting-edge technologies and industry expertise to provide innovative, reliable solutions for spine surgeons and their patients. With a proven track record of clinical success and a continuous innovation drive, icotec aims to shape the future of spinal surgery. Their extensive product portfolio has received FDA approval and has the endorsement of numerous key opinion leaders and cancer therapy centers globally. Learn more about icotec at icotec-medical.com.

For inquiries regarding this new indication, please reach out to John Clough, Vice President of Global Marketing and New Indications at icotec.