The infection-fighting material used in Cleanfuze is a ‘super silicate’ molecule composed of antimicrobial silver ions compounded into the plastic spinal interbody cage.

A silver ion-based antimicrobial material that mitigates surgical site infections (SSIs) in spinal procedures will be built into a spinal implant. The material, Cleanfuze from Difusion Technologies Inc, Austin, Texas, has been through a series of laboratory tests that show its effectiveness. The company says tests validate the controlled antimicrobial release of ionic silver and antimicrobial efficacy, by producing a 5 log reduction in microbial counts, meaning it is 99.999% effective. No antibiotic works this well, says the firm.

The material is antimicrobial PEEK spinal interbody cage capable of stopping biofilm formation for up to four weeks in the bone-graft site and thereby postoperatively eliminating 650 types of bacteria including antibiotic-resistant bacteria such as MRSA. The infection-fighting material used in Cleanfuze is a ‘super silicate’ molecule composed of antimicrobial silver ions compounded into the plastic spinal interbody cage. After implanting Cleanfuze interbody cage into the spinal disc space during surgery, silver ions exchange with naturally occurring sodium ions in the bloodstream and diffuse antimicrobial silver ions.

The company says the development will improve infection ratios and save patients from additional surgery, weeks of IV antibiotics, and in some extreme cases life-long exposure to oral suppressive antibiotics, amputation, and death.

Hospital acquired infections are among the top ten leading causes of death in the U.S., accounting for an estimated 1.7 million infections and 99,000 associated deaths in 2002. SSIs occur within spinal surgery from 2.5 to 13% of the time.

“The problem costs hospitals and insurance carriers over $100,000 per SSI incidence. The material has potential to obviate spinal surgical site infections and save hospitals millions a year in costs from treating these infections,” says Peter Whang, 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.

Orthopedic surgeons will not have to alter currently accepted surgical techniques to use the material nor use new implantation instruments. Hospital and insurance carriers will not be required to implement new procedure codes. The company intends to conduct appropriate filings to facilitate full FDA clearance by the end of 2009.