DiFusion gets CE Mark, European clearance to market CleanFuze antimicrobial orthobiologic polymer
Published on February 25, 2014 at 8:40 AM
DiFusion Incorporated announced today that the company has received a CE Mark and European clearance to market and implant its new CleanFuze™ antimicrobial orthobiologic polymer. "We are extremely gratified to announce European clearance of our CleanFuze™ line of antimicrobial spinal implants. This material has been in development for over five years and attaining this milestone represents significant value for our shareholders," commented DiFusion Cofounder and CEO Derrick Johns.
Health and Human Services (HHS) has characterized surgical site infections (SSIs) as the number one "never event" under the new Affordable Care Act (ObamaCare). Since its passage, there has been a scramble for medical device companies to deliver antimicrobial device based solutions to combat drug resistant forms of bacteria which are the number one cause of failure for hip and knee replacements. SSIs are also the 4th largest cause of death in the US and have a higher mortality rate than auto accidents, breast cancer and HIV combined!