AcryMed Inc. today announced clearance from the Food And Drug Administration (FDA) for the first use of SilvaGard, the company’s breakthrough silver nanotechnology that can render existing medical devices impervious to infection-causing bacteria. Unlike any other infection control technology available today, SilvaGard can be used to treat virtually any medical device and its use does 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 Centers for Disease Control (CDC) 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.
The initial FDA clearance was given to I-Flow Corporation for marketing the company’s ON-Qâ 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.
“We are excited to be the first company to gain FDA clearance for the use of this breakthrough antimicrobial technology, specifically in our unique ON-Q SilverSoaker” said Donald M. Earhart, I-Flow’s chairman, president and CEO. “I-Flow has always been at the forefront of medical advancements in our markets and we believe this will prove to be a significant milestone in the fight against hospital-related infections.”
“It has been a pleasure working with I-Flow to receive the first FDA clearance for use of SilvaGard,” said Jack D. McMaken, president and CEO of AcryMed Inc. “And now that a predicate product has been approved we expect that more clearances will be forthcoming. Even in the early stage, interest among medical device manufacturers was very strong. We are already in development talks with over a dozen other device manufacturers who have approached AcryMed about using SilvaGard for the treatment of their devices, from silicone catheters to titanium implants.”
A New Era In Fighting Infections
Manufacturers of medical devices have long been searching for an effective, low-cost way to easily incorporate antimicrobial protection with their devices. Prior to SilvaGard, other antimicrobial technologies had at least one of four problems. Some could not be applied to certain elastic or interior surfaces of the device. Others altered the original characteristics of the product making it unsuitable for the intended use, or requiring expensive reengineering. Still more concerns regarding current technologies ranged from length of effective sustainability to the cost of application. SilvaGard addresses all of these problems.
Ionic silver has been long recognized and used as a highly effective antimicrobial. SilvaGard nanotechnology provides an easy, cost-effective method of applying a surface treatment of ionic silver to a device. The devices can be treated to provide effective antimicrobial protection for days, weeks, or even months, depending upon application requirements.
