Medegen, a leading innovator in infusion therapy products, today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its new MaxGuard Advanced Luer Activated Device featuring Agion® Antimicrobial Technology. MaxGuard is the first positive displacement needleless connector featuring impregnation of the antimicrobial additive into each of the components of the device. Laboratory testing has demonstrated this new antimicrobial device exhibits a kill rate of greater than 99.99 percent representing a 4-plus log reduction on infection-causing organisms predominantly responsible for catheter-related bloodstream infections.
Medegen routinely receives input from IV therapy clinicians regarding unmet needs and new product concepts. In 2006 clinical end users requested that Medegens leading device, the MaxPlus® Positive Displacement Connector, be offered with a clear housing to facilitate visualization of the fluid path. In February 2008, Medegen released the MaxPlus Clearâ„¢ which quickly became a leading product for the company because of the consistent and dramatic bloodstream infection reduction results it has brought to hospitals nationwide. Last year, MaxPlus clinical users requested an antimicrobial version of the MaxPlus Clear device for use on immunocompromised patients. Today, Medegen is once again fulfilling the clinical users requests by announcing FDA clearance of the new MaxGuard Advanced Luer Activated Device with Antimicrobial Technology.