Curos® Disinfecting Port Protector Gains Extended Approval From FDA

Abstract

San Diego based Ivera Medical Corporation has announced it has received a new FDA 510(k) clearance for its Curos disinfecting port protector, allowing it to claim improved performance including a reduction in disinfection time and an extension of the product’s effective duration of use.

Background

The Curos passive disinfection cap, designed to reduce hospital-acquired catheter related bloodstream infections, first received 510(k) clearance in 2008. According to a company statement, 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.

Company comments

“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.”

“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.”

“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.”

And what about Europe?

The product does carry  CE marking and the company is establishing European distribution at this time.

The full press release can be found here.

Source: Ivera