FDAnews Device Daily Bulletin


Dec. 13, 2005

AcryMed recently announced that the FDA had approved its device, SilvaGard, a silver nanotechnology that protect medical devices from infection-causing bacteria.

The group argues that this nanotechnology is unique in that it can be used to treat any medical device and will not alter the device's original properties. "Due to these and other unique attributes, SilvaGard is expected to have a significant impact on the battle against hospital-related infections," the group said.

The initial FDA clearance was given to I-Flow Corporation for marketing the company's ON-Q SilverSoaker regional anesthesia delivery catheters. ON-Q SilverSoaker catheters are treated with AcryMed's SilvaGard, a silver nanoparticle antimicrobial coating that protects against the formation of infection-causing biofilm.

The Centers for Disease Control estimates that 2 million U.S. patients a year acquire hospital-related infections. These infections cost an average of $47,000 per patient to treat and cause 90,000 deaths each year. The added cost to hospitals is $4.8 billion annually in extended care and treatment.