DiFusion Technologies completes antimicrobial spinal implant testing.

DiFusion Technologies, Inc., reports the successful completion of 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 the company's first spinal implant called CleanFuze.

Laboratory tests validated the controlled antimicrobial release of ionic silver and antimicrobial efficacy, achieving a five-log reduction in microbial counts, which is 99.9 percent effective.

According to the company, no antibiotic is able to achieve this level of efficacy. In response to the rising incidence of spinal surgery SSIs, which have been reported in large studies to range from 2.5 to 13 percent, DiFusion developed CleanFuze, an antimicrobial PEEK spinal inter-body cage that the company claims is capable of stopping biofilm formation in the bone graft site and eliminating 650 types of bacteria including antibiotic-resistant bacteria such as Methicillin-resistant Staphylococcus aureus for up to four weeks postoperatively.

"DiFusion is targeting a problem that costs hospitals and insurance carriers over $100,000 per SSI incidence, and CleanFuze has the potential to not only obviate spinal surgical site infections, but also save hospitals millions of dollars a year in associated costs to treat these infections," said Peter Whang, M.D., a member of DiFusion's scientific advisory board and an assistant professor in the Department of Orthopaedics and Rehabilitation at the Yale University School of Medicine in New Haven, Conn. "Moreover, as of October 2008, the Centers for Medicare and Medicaid Services are no longer paying for hospital-acquired infections; therefore, healthcare facilities are going to have to absorb these staggering costs."

According to Matthew Geck, M.D., an orthopedic surgeon in Austin, Texas, and founder of DiFusion, the company's technology addresses the U.S. Department of Health and Human Services' action plan released in January to reduce and eliminate healthcare-associated infections.

The infection-fighting material used in the device is a "super silicate" molecule composed of antimicrobial silver ions that is compounded into the plastic spinal inter-body cage.

Once the cage is implanted into the spinal disc space during surgery, silver ions exchange with naturally occurring sodium ions in the bloodstream and diffuse antimicrobial silver ions for a period of four weeks.

The CleanFuze device releases 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, the DiFusion device contains embedded antimicrobial properties, which company officials say significantly enhances its effectiveness.