Garwood Medical Devices said today that it has won FDA breakthrough device designation for the BioPrax device for eliminating biofilm infections on prosthetic knee implants.
BioPrax is a minimally invasive device designed to deliver a low-voltage electrical treatment to the surface of a knee implant and kill bacteria associated with biofilm infections. The device has been shown to reduce the viability of clinical biofilms by up to 99.9%, according to Buffalo, N.Y.-based Garwood.
Currently, BioPrax is under investigation for eliminating biofilm infections during early intervention procedures while maintaining the standard of care.
Garwood said it plans to expand the device’s use to other metal implants, including all artificial joints, bone screws and plates, and dental implants.
“This is an exciting step toward improving the standard of care and success rates for the treatment of biofilm infections,” CEO Wayne Bacon said in a news release. “Breakthrough device designation by the FDA is recognition that BioPrax appears to be on the right path toward the treatment of periprosthetic joint infections in knee implant patients.”
Original Article: (https://www.massdevice.com/garwood-medical-wins-fda-breakthrough-nod-for-biofilm-disruption-device/)