Ivera Medical’s Curos Port Protector Gets Expanded FDA Clearance

Ivera Medical’s Curos Port Protector Gets Expanded FDA Clearance

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 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.”

The Curos disinfecting port protector cap may be used in the home or healthcare facility and is intended for use on swab-able luer-activated IV valves to both disinfect and protect vulnerable points of entry to the patient’s bloodstream. According to the new 510(k) clearance, Curos will disinfect the valve three minutes after application and act as a physical barrier to contamination for up to seven days if not removed. The effectiveness of Curos disinfecting port protectors were tested in vitro and found to provide effective disinfection of gram positive organisms (Staphylococcus aureus and Staphylococcus epidermidis), gram negative organisms (Escherichia coli and Pseudomonas aeruginosa) and fungi (Candida glabrata and Candida albicans.)

In a six-month controlled study conducted by a university hospital Curos contributed to an 86.2 percent reduction in CLABSI and a 92 percent fall in contaminated blood cultures in a 12-bed bone marrow transplant unit and 20-bed oncology unit. Annualized cost avoidance (within the 32-bed study area) as a result of Curos use was estimated at $500,000. Researchers concluded that the reduction in CLABSI rate and the efficacy of Curos, in part, is ascribed to the easily monitored disinfection compliance (greater than 85 percent on average.)

Although disinfection caps are a simple solution for hospital infection prevention — an alcohol-soaked foam inside a small plastic screw cap — much thought and ingenuity were required to develop it. Curos technology is designed to integrate smoothly with clinical practice, support port protection compliance and avoid waste in product use and disposal.

“We carefully engineered every detail of Curos to be more safe and effective. Even the distinctive green color was chosen specifically to allow clinicians to verify that a port is clean — at a glance — without creating confusion among other colors which imply specific therapies such as enteral tubes. We’ve created dispensing methods that put Curos in reach when and where nurses need them and limit the packaging waste to the bare minimum,” stated Rogers. “A key component in the fight against hospital-acquired bloodstream infections is the ability to put validated tools into the hands of caregivers. The FDA’s 510(k) clearance of Curos is a pivotal step in that direction, and reinforces Ivera’s commitment to providing higher-quality and innovative solutions to our customers.”

About Ivera Medical (www.iveramed.com)

Ivera Medical Corporation is focused on the design, development, manufacture, marketing and sale of products that help healthcare providers reduce hospital-acquired patient infections. Curos, manufactured in Carlsbad, CA, is the first disinfecting cap to be marketed in the U.S. and has received FDA’s 510(k) market clearance. For more information about Curos and Ivera Medical, visit the website at www.curos.com.

The Curos® Port Protector is a simple, innovative, disposable infection control product intended for use on swabbable luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. Curos will disinfect the valve three minutes after application and act as a physical barrier to contamination for up to 7 days if not removed.

The Curos® Port Protector:

Effectively disinfects luer-lock needleless valves, killing the organisms associated with catheter-related bloodstream infections.

Assures high visibility compliance with hospital infection control protocols – the vibrant green cap is easy to see and will not be confused with other color-indicated therapies

Protects iv access ports and needleless connectors between accesses – keeping ports always protected and clean

Minimizes packaging waste

Simply peel off the seal and twist Curos® Port Protector disinfection cap over the top of a luer-activated IV access port. Inside this revolutionary green cap is a 70% IPA (isopropyl alcohol) saturated sponge-like foam. Once secured, the Curos Port Protector automatically provides effective, consistent and reliable passive disinfection of the port.

Hospitalized patients with bloodstream infections have extended lengths of stay, which increase patient and hospital costs, and contribute to higher incidence of mortality.2-5

Valves have been associated with increases in BSI rates.1 As part of a broader infection control program, effective disinfection of valves may reduce microbial ingress into the patient’s bloodstream which may lead to improvements in catheter-related bloodstream infection (CRBSI) rates.

1.Jarvis WR, Murphy C, Hall KK, Fogle PJ, Karchmer TB, Harrington G, Salgado C, Giannetta ET, Cameron C, Sherertz RJ. Health care-associated bloodstream infections associated with negative- or positive-pressure or displacement mechanical valve needleless connectors. Clin Infect Dis. 2009 Dec 15;49(12):1821-7. Free Article

2.Pittet, D., Tarara, D., Wenzel, R. P. Nosocomial bloodstream infection in critically ill patients: excess length of stay, extra costs and attributable mortalilty. JAMA 1994; 271:1598-601.

3 Eggimann, P., Sax, H., Pittet, D. Catheter-related infections. Microbes Infect 2004; 6:1033-42.

4 Byers, K. E., Adal, K. A., Anglim, A. M., Farr, B. M. Case fatality rate for catheter-related bloodstream infections: a meta-analysis (abstract 43). 5th Annual Meeting of the Society of Healthcare Epidemiology of America. San Diego: Mt. Royal, NJ: The Society of Healthcare Epidemiology of America; 1995; 16(4):23.

5 Rosenthal, V. D., Guzman, S., Migone, O., Crnich, C. J. The attributable cost, length of hospital stay, and mortality of central line-associated bloodstream infection in intensive care departments in Argentina: a prospective, matched analysis. Am J Infect Control 2003; 31:475-80.

Source : http://www.curos.com/fda-grants-510k-clearance-to-curos%C2%AE-disinfecting-port-protector

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