icotec's FDA Clearance for BlackArmor® Implants Revolutionizes Spinal Infection Treatment
In a groundbreaking development, icotec has announced that it has received FDA clearance for the use of its innovative BlackArmor® implants in treating de novo spinal infections. This advancement makes icotec the first and only company in the United States with FDA 510(k) approval for spinal stabilization procedures catering specifically to infections such as discitis, osteomyelitis, and pyogenic infections of the intervertebral disc, as well as other related spondylopathies.
According to Chris Eigenmann, CEO of icotec Medical US, over 15,000 patients undergo spinal stabilization treatments due to infections in the United States annually. "Being able to aid these patients using implants that offer enhanced post-operative monitoring and visualization is both a great opportunity and an immense privilege," Eigenmann noted. In addition to receiving on-label designation, icotec's BlackArmor® implants have also been granted a Breakthrough Device Designation (BDD) by the FDA, acknowledging the significant unmet medical needs these implants address and the innovative benefits they offer.
Following the FDA's endorsement, the Centers for Medicare and Medicaid Services (CMS) have also approved the BlackArmor® implants for New Technology Add-on Payment (NTAP). This designation is crucial as it allows hospitals additional reimbursement for delivering advanced medical technology to Medicare beneficiaries who significantly benefit from these innovations, with potential payments reaching up to $28,000 for procedures involving the VADER® pedicle screw system beginning October 1, 2024.
Clinical studies underline the value of icotec's BlackArmor® implants, which utilize radiolucent Carbon/PEEK material. This unique composition minimizes imaging artifacts, thus enhancing post-operative evaluations and follow-up monitoring of infections. Notable research, including studies like Burkhardt et al. (2021), indicates that the complication rates associated with these implants are comparable to traditional titanium implants, while also revealing their imaging advantages. "Thanks to extensive clinical data collected in Germany over recent years, we are now able to provide a specialized implant option to spinal infection patients in the U.S. This recognition from the FDA validates the potential effectiveness of carbon fiber implants in this patient demographic," explained Roger Stadler, Group CEO.
As icotec continues to gather further clinical evidence supporting the efficacy and safety of BlackArmor® implants in managing spinal infections, their dedication to research and innovation remains steadfast. The firm is committed not only to pioneering advancements in spinal surgery but also to enhancing the standard of care for patients dealing with challenging spinal infections. The comprehensive product range provided by icotec has already achieved FDA clearance and is bolstered by the support of key opinion leaders and comprehensive cancer therapy centers globally.
For anyone seeking additional information about this new indication or the implications it carries for spinal care, John Clough, Vice President of Global Marketing and New Indications, is available to address inquiries. By combining cutting-edge technology and industry expertise, icotec is undoubtedly setting new benchmarks in the treatment of spinal tumors and infections, with their BlackArmor® line marking a significant step forward in the field of spinal implants.
According to Chris Eigenmann, CEO of icotec Medical US, over 15,000 patients undergo spinal stabilization treatments due to infections in the United States annually. "Being able to aid these patients using implants that offer enhanced post-operative monitoring and visualization is both a great opportunity and an immense privilege," Eigenmann noted. In addition to receiving on-label designation, icotec's BlackArmor® implants have also been granted a Breakthrough Device Designation (BDD) by the FDA, acknowledging the significant unmet medical needs these implants address and the innovative benefits they offer.
Following the FDA's endorsement, the Centers for Medicare and Medicaid Services (CMS) have also approved the BlackArmor® implants for New Technology Add-on Payment (NTAP). This designation is crucial as it allows hospitals additional reimbursement for delivering advanced medical technology to Medicare beneficiaries who significantly benefit from these innovations, with potential payments reaching up to $28,000 for procedures involving the VADER® pedicle screw system beginning October 1, 2024.
Clinical studies underline the value of icotec's BlackArmor® implants, which utilize radiolucent Carbon/PEEK material. This unique composition minimizes imaging artifacts, thus enhancing post-operative evaluations and follow-up monitoring of infections. Notable research, including studies like Burkhardt et al. (2021), indicates that the complication rates associated with these implants are comparable to traditional titanium implants, while also revealing their imaging advantages. "Thanks to extensive clinical data collected in Germany over recent years, we are now able to provide a specialized implant option to spinal infection patients in the U.S. This recognition from the FDA validates the potential effectiveness of carbon fiber implants in this patient demographic," explained Roger Stadler, Group CEO.
As icotec continues to gather further clinical evidence supporting the efficacy and safety of BlackArmor® implants in managing spinal infections, their dedication to research and innovation remains steadfast. The firm is committed not only to pioneering advancements in spinal surgery but also to enhancing the standard of care for patients dealing with challenging spinal infections. The comprehensive product range provided by icotec has already achieved FDA clearance and is bolstered by the support of key opinion leaders and comprehensive cancer therapy centers globally.
For anyone seeking additional information about this new indication or the implications it carries for spinal care, John Clough, Vice President of Global Marketing and New Indications, is available to address inquiries. By combining cutting-edge technology and industry expertise, icotec is undoubtedly setting new benchmarks in the treatment of spinal tumors and infections, with their BlackArmor® line marking a significant step forward in the field of spinal implants.
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