DiFusion, a US-based medical device firm focused on surgical site infections in orthopedic and spine surgery, has completed a series of in vitro tests and an in vivo study at Clemson University to validate the efficacy of its new orthobiologic polymer-CleanFuze.
The in vivo study showed that CleanFuze resists biofilm formation while third party in vitro antimicrobial testing revealed 99.9% reduction in S.aureus colonies, as compared to antimicrobial material-silicon nitride.
DiFusion CEO Joe Crudden said that the bacteria attach themselves to the surfaces of conventional surgical implants and form biofilms, which provide a protective environment where the microorganisms can proliferate and develop antimicrobial resistance.
"These studies establish the potential of CleanFuze to strongly inhibit the development of bacterial biofilm while displaying superior osteoblast adhesion when compared to conventional PEEK," Crudden added.
DiFusion managing director Derrick Johns said, "CleanFuze, a new material is currently being developed for interbody devices, can be applied to any metal implant, giving it a competitive advantage over common metal implants that are susceptible to biofilm formation."
"This technology could potentially save millions of dollars for your average sized hospital, as penalties are phased in under ObamaCare," Johns added.
DiFusion plans to launch CleanFuze in the European Union in the fourth quarter of 2013.