BioPrax, a minimally invasive device that is under investigation to help eliminate biofilm infections on prosthetic knee implants during early intervention procedures, has been granted Breakthrough Device designation by the Food and Drug Administration (FDA), its manufacturer, Buffalo, NY-based Garwood Medical Devices, announces.
“This is an exciting step towards improving the standard of care and success rates for the treatment of biofilm infections,” says Wayne Bacon, CEO of Buffalo, NY-headquartered Garwood Medical Devices, in a media release.
“Breakthrough Device designation by the FDA is recognition that BioPrax appears to be on the right path towards the treatment of periprosthetic joint infections in knee implant patients.”
BioPrax is designed to provide a low-voltage electrical treatment to the surface of the knee implant, creating an environment that kills bacteria associated with biofilm infections. In studies conducted to date, BioPrax has been shown to reduce the viability of clinical biofilms by up to 99.9% across multiple combinations of bacterial strains and metal types, the release suggests.
In future device generations, Garwood will be seeking to expand the use of this technology to help eliminate biofilm infections on other medically implanted metal devices including all artificial joints, bone screws and plates, and dental implants.
Breakthrough Device Designation from the FDA is granted to certain medical devices that have the potential to provide an effective treatment of life-threatening or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, per the release.
[Source(s): Garwood Medical Devices, PR Newswire]
