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In Brief: Rochester Medical

This article was originally published in The Gray Sheet

Executive Summary

Rochester Medical: Randomized, 400 patient clinical study conducted at the University of Wisconsin, Madison, shows the firm's nitrofurazone-impregnated antibacterial Foley catheter is associated with a lower incidence of catheter-related bacterial urinary tract infections than non-medicated catheters in patients catheterized from one to seven days. The company, which expects to submit a 510(k) for the device within the next several months, claims that patients with non-medicated catheters had three times the rate of bacterial infections. "No adverse reactions were seen" with the device, said lead investigator Dennis Make, MD, University of Wisconsin Medical School, Madison, Wisconsin...

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