icotec's BlackArmor® Implants Receive FDA Clearance for Spinal Infections

icotec's BlackArmor® Implants Obtain FDA Clearance

icotec Medical, Inc. is thrilled to announce that it has achieved FDA clearance for the use of its innovative BlackArmor® implants in addressing de novo spinal infections. This monumental step makes icotec the pioneer and sole company in the United States empowered with FDA 510(k) clearance for stabilizing the spine in cases of spinal infections such as discitis, osteomyelitis, pyogenic infection of the intervertebral disc, and other forms of spondylopathies.

Chris Eigenmann, CEO of icotec Medical US, highlighted the significance of this development, stating, "Each year in the USA, over 15,000 patients undergo spinal stabilization due to infections, and we are honored to provide them with an implant that allows enhanced post-operative monitoring and visualization. This not only represents a great opportunity, but also a privilege to contribute to patient care."

In an added layer of recognition for innovation, the FDA has granted a Breakthrough Device Designation (BDD) for this indication across icotec's entire BlackArmor® spinal stabilization product line. This designation emphasizes the significant unmet needs addressed by the technology and its novel benefits for those affected by spinal infections.

Support from Medicare and Research Evidence

In alignment with the FDA's decision, the Centers for Medicare and Medicaid Services (CMS) have sanctioned BlackArmor® for New Technology Add-on Payment (NTAP). This is an essential support structure awarded to advanced medical technologies that demonstrate significant improvements in diagnosing or treating Medicare beneficiaries.

icotec's BlackArmor® implants boast advanced radiolucent properties due to their Carbon/PEEK construction, which significantly reduces imaging artifacts. This characteristic enhances imaging capabilities in both the post-operative assessment and ongoing infection monitoring for patients. Clinical studies, including findings from researchers like Burkhardt et al. (2021), have showcased the safety profile of these implants, revealing complication rates comparable to those of traditional titanium implants. Moreover, the reduction of imaging artifacts offers added diagnostic advantages for patients stabilized with Carbon/PEEK implants. Roger Stadler, Group CEO of icotec, commented, "Thanks to years of clinical data gathered in Germany, we now provide a dedicated implant option specifically tailored for spinal infection patients in the U.S. The FDA's recognition of the potential of carbon fiber implants for this patient demographic highlights our commitment to clinical excellence and innovation."

Additional clinical research supporting the safety and efficacy of BlackArmor® implants for treating spinal infections is actively being conducted.

Financial Support for Innovation

Starting October 1, 2024, hospitals will have the opportunity to receive additional payments of up to $28,000 for the VADER® pedicle screw system catering to Medicare Fee-for-Service patients. This NTAP designation underscores the unique clinical value of icotec's products and reinforces the company's dedication to elevating care standards for spinal infection patients.

About icotec

icotec stands as a leader in the treatment of spinal tumors and infections, offering a new generation of advanced implants. The BlackArmor® Carbon/PEEK implants represent the integration of pioneering technologies with in-depth industry expertise, designed to provide innovative and dependable solutions for both spinal surgeons and their patients. Committed to advancing spinal implantation practices and continuously fostering innovation, icotec is poised to redefine the future of spinal surgery. The expansive product line has successfully passed FDA scrutiny and boasts endorsements from leading opinion leaders and cancer therapy centers globally. To learn more, please visit icotec's website.

For inquiries or further details about this new indication, please reach out to John Clough, the Vice President of Global Marketing and New Indications.