The US Food and Drug Administration (FDA) has granted 510(k) approval to Avery Dennison Medical Solutions' new non-cytotoxic, grade 0 profile transparent wound film dressing, designed to treat catheter-related blood stream infections.
The CHG adhesive formulation used on the dressing is transparent to allow visualization of the access site, which is a critical parameter for vascular access professionals including nurses and infection-control specialists.
In-vitro test data of BeneHold dressing showed antimicrobial efficacy across a broad range of bacteria and yeast commonly found in catheter-related blood stream infections.
The data also demonstrated that the film dressing shows significant reduction in bacteria and yeast from day 1 through day 7.
Avery Dennison Medical Solutions vice president and general manager Howard Kelly said the company looks forward to make CHG antimicrobial technology more accessible for clinicians and their patients.
"This product will expand our vascular access offering and help ensure that more users can benefit from the latest advancements in vascular access care," Kelly added.
The transparent film dressing, which will available in the US in fall 2013, has potential to be used in future applications including surgical incise films and post-op dressings.
In addition to the US launch, the company is planning to file an regulatory application for CE mark.