By Karen Roman
Orthobond Corp. said the Food and Drug Administration approved its request to market Ostaguard, an antibacterial surface treatment used on permanent spine implants.
This is the first time the FDA granted approval for a medical device with a non-eluting coating created to actively kill bacteria contaminating surfaces, the company said. Studies have found 70% to 100% of failed joint implants show some level of contamination with consequent pain and restricted mobility, Orthobond said.
The company created a method to covalently-bond its antibacterial molecule to the surface of implants, which was tested against 12 microbes constituting almost all cases of device-related infections, it noted.
“We are proud of our evidence-based submission to the FDA and look forward to making our innovative technology available to a wide variety of customers,” said CEO David Nichols. “We believe our surface coating has the potential to be the standard of care for implantable devices to protect patients from pathogens, and that this will be transformative to the field of surgery and beyond.”
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