Navigation Links
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."

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.)

Curos disinfects needless IV connectors to help prevent catheter-related bloodstream infections (CRBSI) including central line associated bloodstream infections (CLABSI) and to reduce the incidence of contaminated blood cultures. 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, headquartered in Carlsbad CA, developed and markets Curos disinfecting port protectors, the first disinfecting cap to be marketed in the US. Ivera's mission is to provide technologies and support services that help healthcare providers reduce the incidence of preventable bloodstream infections.  Hospital-acquired infections are estimated to cause or contribute to over 99,000 deaths annually, and to add nearly $6 billion each year to the cost of health care.     

Contact:
Bob Rogers
Chief Executive Officer
Ivera Medical Corp.
Bob.rogers@iveramed.com
760-612-6090


'/>"/>
SOURCE Ivera Medical Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Optimer Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
2. US Patent Office Grants COPAN Invention of Flocked Swabs
3. The European Commission Grants Marketing Authorization for DIFICLIR™ (fidaxomicin) Tablets for Treatment of Clostridium difficile Infections
4. Watson Confirms Court Grants Preliminary Injunction Preventing Launch of Generic LOVENOX®
5. FDA Awards NIPTE Potential $35 Million in Grants to Reform Drug Manufacturing Process
6. Optimer Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
7. Pevion Grants CSL Option Right to its Therapeutic Candida Vaccine
8. Muscular Dystrophy Association Awards $13.7 Million for 40 New Research Grants
9. FDA Grants Fast Track Designation to Bayers Investigational Compound Radium-223 Chloride for the Treatment of Castration-Resistant Prostate Cancer That Has Spread to the Bone
10. Echo Therapeutics Announces Multiple Patents and Trademark Grants
11. FDA Grants Orphan Drug Status to Merrimack Pharmaceuticals MM-398, a Nanotherapeutic Encapsulation of Irinotecan, for the Treatment of Pancreatic Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... 20, 2017  RXi Pharmaceuticals Corporation (NASDAQ: RXII), ... address significant unmet medical needs, today announced that ... consumer product development program, based on its proprietary ... Investigative Dermatology (SID) 76 th Annual Meeting.  ... the sciences relevant to skin health and disease ...
(Date:4/20/2017)... April 20, 2017   ZappRx, Inc ., a digital ... prescribing process, today announced it closed $25 million in Series ... capital firm based in Seattle that ... Partners . The Series B round included participation from ... 2014, and GV (formerly Google Ventures). As part ...
(Date:4/20/2017)... 2017 Eyevensys, a private biotechnology ... gene expression technology that enables the safe, local, sustained ... a wide range of ophthalmic diseases, announces it has ... Regulatory Agency (MHRA) to advance its technology into clinical ... The ...
Breaking Medicine Technology:
(Date:4/28/2017)... ... ... People are starting to accept that hearing aids can be helpful and ... it had when great-grandpa wore his hearing aids years ago,” said Dr. Maura Marks, ... American Speaker Series (NASS) segment. “He probably wore an iPod-size hearing aid on ...
(Date:4/28/2017)... Pensacola, FL (PRWEB) , ... April 28, 2017 ... ... Tampa, Florida are conducting a pilot study of ActiGraph’s CentrePoint Data ... ActiGraph is a leading provider of clinical-grade wearable activity and sleep monitoring solutions ...
(Date:4/28/2017)... ... April 28, 2017 , ... Woolsy Corporation Limited, a ... its Nova Skin Sciences division, recently announced the launch of Allumière Antiaging Cream, ... power of an anti-aging concentrate. , Anogeissus Leiocarpa Bark Extract and ...
(Date:4/28/2017)... ... April 28, 2017 , ... Semrock’s ... is the premier online modeling resource for fluorescence microscopists and optical system designers, ... during last 5 years spanning the globe, SearchLight has become a tremendously popular ...
(Date:4/27/2017)... DC (PRWEB) , ... April 27, 2017 , ... ... Behavioral Economics Insights in Incentives, Rewards, and Recognition: A Nudge Guide," a groundbreaking ... recognition (IRR) field. Offering practical takeaways to apply immediately to IRR programs, the ...
Breaking Medicine News(10 mins):