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DiFUSION Technologies Finishes Successful Testing Of CleanFUZE

DiFUSION Technologies, Inc. announced that it has successfully completed a series of laboratory tests of its silver ion-based antimicrobial technology designed to mitigate Surgical Site Infections (SSIs) in spinal surgery. The technology will be incorporated into DiFUSION’s first spinal implant CleanFUZE. Laboratory tests validate the controlled antimicrobial release of ionic silver and antimicrobial efficacy, achieving a 5 log reduction in microbial counts which is 99.999% effective. In response to the rising incidence of SSIs within spinal surgery, which have been reported in large studies to range from 2.5% to 13%, DiFUSION has developed CleanFUZE, an antimicrobial PEEK spinal interbody cage capable of stopping biofilm formation in the bone graft site and eliminating 650 types of bacteria including antibiotic-resistant bacteria such as MRSA for up to four weeks postoperatively. DiFUSION’s solution will not only improve infection ratios, it will also save the patient from additional surgery, weeks of IV antibiotics and in some cases life long exposure to oral suppressive antibiotics, amputation and even death; benefits that will impact surgeons, patients, hospitals and insurance carriers. The infection-fighting material used in DiFUSION’s CleanFUZE is a ‘super silicate’ molecule composed of antimicrobial silver ions that is compounded into the plastic spinal interbody cage. Once the CleanFUZE interbody cage is implanted into the spinal disc space during spinal surgery, silver ions exchange with naturally occurring sodium ions in the bloodstream and diffuse antimicrobial silver ions for a period of 4 weeks. DiFUSION’s CleanFUZE will be capable of releasing its dosage amount over time and the rate of diffusion can be controlled by parts-per-billion. Additionally, rather than antimicrobial coatings currently used in devices, CleanFUZE contains antimicrobial properties embedded in the device, significantly enhancing the effectiveness. DiFUSION intends to conduct the appropriate filings to facilitate full FDA clearance by the end of 2009.