SALT LAKE CITY--(BUSINESS WIRE)--Catheter Connections, a leading developer of medical devices for the prevention of catheter related bloodstream infections, announced today that it denies all allegations of its competitor’s, Ivera Medical, most recent legal filings attacking the disinfection performance of DualCap® for male luer connectors (Case No. 3:14-cv-01997-BAS-JLB, U.S. District Court, District of Southern California). DualCap is FDA-cleared, safe, effective, and has been fully tested by an independent, FDA-registered and accredited laboratory.
“Ivera’s latest attack on DualCap is completely without merit,” said Donald Solomon, Ph.D., Senior Vice President of Operations and Engineering and Chief Technology Officer of Catheter Connections. “The FDA cleared our DualCap for male luer connectors in 2010 after an extensive review of the lab protocols, analysis and results we submitted. Based upon its review, the FDA allows the indication that DualCap disinfects within five minutes and then acts as a physical barrier to contamination for 96 hours if not removed. Nelson Laboratories, a nationally recognized, independent, FDA-registered and ISO 17025 accredited lab, performed our DualCap testing. The data generated by Nelson Laboratories was extremely rigorous and directly contradicts the Ivera-sponsored tests. Ivera’s test design is flawed and the results are wrong. It is worth noting Catheter Connections believes that all of Ivera’s commercialized Curos® Tips™ products are not FDA cleared.”
“Ivera’s desperate actions are the result of the excitement and impressive traction DualCap is gaining in the global marketplace and our recently granted preliminary injunction against them (Case No. 2:14-cv-00070-TC, U.S. District Court, District of Utah),” said Vicki Farrar, Founder, President and Chief Operating Officer of Catheter Connections. “Ivera’s speculations about DualCap are just that, speculations, and are not surprising given its recent losses to Catheter Connections and the superiority of our products. One reason Ivera may be attempting to create confusion is its realization that we own the patents and intellectual property necessary for long-term success in the disinfecting cap market. As DualCap rapidly expands across the world, we anticipate that Ivera will continue to attempt to discredit the strength and value of our products and distract us from our ultimate goal: save lives by reducing catheter related bloodstream infections.”
About Catheter Connections®
Headquartered in Salt Lake City, Utah, Catheter Connections, Inc., develops and commercializes innovative vascular access products designed to protect patients from acquiring infections during intravenous infusion therapy. Its DualCap System™ is a family of user-friendly products that provides healthcare facilities with a cost-effective, integrated solution for IV disinfection and protection, helping in the fight against IV catheter-related blood stream infections. Designed by nurses for nurses, flagship product DualCap® safely disinfects both IV tubing end connectors and IV catheter access valves—a major breakthrough for infection control. For more information, visit dualcap.com.