DiFusion Technologies, a medical device company based out of Austin, Texas, has developed a silver ion technology called CleanFUZE, designed to prevent infection after orthopedic procedures. Dr. Matthew Geck, the company’s founder, explained that “five out of 100 spine cases result in Surgical Site Infections (SSI) often leading to second surgeries that are extremely costly and difficult for the patient.” CleanFUZE could potentially save the health care system $150 million annually. The number may seem small compared to the billions of dollars thrown around on Wall Street, but it’s a start! The company plans to submit the device for approval by the FDA later this year.
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.