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news.Medegen, a provider of infusion therapy products, has received 510(k) clearance from the FDA for its new MaxGuard advanced Luer activated device featuring Agion antimicrobial technology.
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MaxGuard is claimed to be the first positive displacement needleless connector featuring impregnation of the antimicrobial additive into each of the components of the device. Laboratory testing has demonstrated that this new antimicrobial device exhibits a kill rate of greater than 99.99% representing a 4+ log reduction on infection-causing organisms predominantly responsible for catheter related bloodstream infections, the company said.
With the addition of antimicrobial technology, MaxGuard is an enhancement of the MaxPlus Clear, Medegen’s positive displacement connector. MaxGuard also features Medegen’s patented Tru-Swab top which acts as a double seal barrier to contamination and allows for true disinfection during pre-access swabbing. The translucent housing provides for visualization of the fluid path allowing for complete flushing of the device, the company said.
Jeffrey Goble, president of Medegen, said: This is a significant achievement in Medegen’s ongoing pursuit to develop programs and products that help clinicians prevent bloodstream infections. Our goal has always been to provide clinicians with products that will significantly improve their efforts to enhance patient care and positive outcomes, and MaxGuard with antimicrobial technology meets that goal.