February 21, 2006

Covalon Technologies has announced that the FDA has approved the company's silver ion- releasing coating for Foley catheters for use in the U.S. This is the company's first FDA approval for a coating application. The coating, made of ionic silver, is used as an antiseptic and is a broad-spectrum antimicrobial agent that eradicates gram-positive bacteria, including several antibiotic-resistant bacteria. It also kills fungi such as yeast.

While the coating is applicable to a wide variety of medical devices that include dialysis lines, PICC lines, and various catheters, it is also applicable to many indwelling medical devices used in hospitals. The devices, often in the form of tubes, provide access to the body for the delivery of fluids, drugs, nutrition and air. The devices also provide a means of removing waste substances from the body through urinary catheters, kidney dialysis, and wound drains.

Since the insertion of devices into the body provide a conduit for skin bacteria and yeast to gain entry, the coating is essential in preventing infection. Infections arising from the use of in-dwelling biomedical devices, especially catheters, are associated with increased morbidity and mortality, prolonged hospitalization, patient discomfort and increased medical costs. Urinary tract infections caused by Foley catheters are among the most prevalent type of hospital-acquired infections.

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