DiFusion Technologies out of Austin, Texas has developed silver ion technology, dubbed CleanFUZE™, designed to prevent infection after orthopedic procedures. The company has applied the method to a PEEK spinal interbody cage capable of stopping biofilm formation in the bone graft and plans to submit the device this year for approval to the FDA.
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.
Unlike other devices on the market, 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.
“Larger companies have spent years and millions of dollars trying to address the SSI problem with antimicrobial coatings which do not fight infection past the first 48 hours. Our technology provides antimicrobial protection for 4 weeks due to ‘controlled cationic release’,” said Dr. Hyun Bae, a member of DiFUSION’s scientific advisory board and a board-certified orthopaedic surgeon in Santa Monica, California, specializing in minimally invasive microsurgery and the treatment of cervical and lumbar spinal disease.
Press release: DiFUSION Technologies Completes Successful Testing of Antimicrobial Spinal Implant
Technology page: CleanFuze