The US Food and Drug Administration (FDA) has granted clearance to icotec for the use of its BlackArmor implants in treating de novo spinal infections.
This is claimed to make icotec the first and only company in the US to receive 510(k) clearance from the US regulator for “stabilising” the spine in conditions such as osteomyelitis, discitis, and other spondylopathies.
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icotec Medical US CEO Chris Eigenmann said: “Over 15,000 patients receive spinal stabilisations due to an infection in the spine in the USA every year, being able to help these patients with an implant that allows for improved post-operative monitoring and visualisation is a great opportunity and privilege.”
The Centers for Medicare and Medicaid Services (CMS) has approved the implants for New Technology Add-on Payment (NTAP). This endorsement is granted to medical technologies that notably enhance the diagnosis or treatment of Medicare beneficiaries.
BlackArmor implants are claimed to provide “reduced” artefacts from radiolucent Carbon/PEEK material, which facilitates “improved” imaging for post-operative monitoring of infections.
Clinical studies, including one by Burkhardt et al. in 2021, have underscored the safety of BlackArmor implants, showing complication rates equivalent to those of titanium implants and the advantage of reduced imaging artefacts.
The company noted that further research supporting the safety and efficacy of the implant in treating spinal infections is underway.
icotec is engaged in developing “high-tech” implants with a focus on the treatment of spinal tumours and infections.
The company’s product range has gained clearance from the FDA and is endorsed by key opinion leaders and cancer therapy centres worldwide.
In July 2023, icotec gained 510(k) clearance from the FDA for its VADER Pedicle System Navigated Instruments.
