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FDA Grants 510(k) Clearance to Curos® Disinfecting Port Protector
Date:1/18/2012

CARLSBAD, Calif., Jan. 18, 2012 /PRNewswire/ -- Ivera Medical Corporation today announced it has received a new FDA 510(k) clearance for its Curos® disinfecting port protector which reflects the company's ongoing determination to continuously improve its products to better deliver solutions designed to reduce hospital-acquired catheter related bloodstream infections. The Curos passive disinfection cap  first received 510(k) clearance in 2008. The new 510(k) clears Curos for improved performance claims including a reduction in disinfection time and an extension of the product's effective duration of use. Independent studies submitted to the FDA established that Curos caps disinfect IV access ports within three minutes and that ports remain clean for seven days without access.

With two dispenser options—the Curos Strip or individual Curos—nurses can conveniently comply with disinfection protocols for intravenous (IV) valves by simply peeling the foil seal off the distinctive green cap and twisting Curos over the top of any luer-activated IV access port or needleless valve. Inside Curos a 70% IPA (isopropyl alcohol) saturated sponge-like foam automatically provides effective, consistent and reliable passive disinfection of the port.

"In the battle to prevent bloodstream infections, the ease of use of a solution is critically important to its effectiveness. Curos is designed for minimal effort and maximum effect," said Bob Rogers, Ivera Medical's chief executive officer. "With a shorter time to disinfection and a longer duration of use, the patient's IV ports are verifiably clean and guaranteed to stay that way between accesses because the Curos design complies with the 2011 INS Standards of Practice which specifies the use of secure lock-locks on all "add-on" devices."

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SOURCE Ivera Medical Corporation
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