Intravenous Catheter System Awaits FDA Clearance

Ann Arbor, Mich.-based Tangent Medical has submitted a 510(k) clearance request to the U.S. Food and Drug Administration (FDA) for its NovaCath Secure Intravenous (IV) Catheter System. The system has been developed in an effort to address several complex IV therapy challenges including catheter stabilization, occupational exposure to blood, and patient discomfort. If the device receives FDA clearance it will be the first safety IV catheter to offer advanced catheter stabilization technology designed to exceed the highest CDC (Center for Disease Control), OSHA (Occupational Safety & Health Administration), and INS (Infusion Nursing Standards) standards for peripheral IV catheter stabilization.

Nurse testimonials featured on the company website point out how that because it is a closed system, there is less “blood mess.” Others claim the system requires less tape and stays in place more readily. Curtis Bloch, Tangent vice president of sales and marketing, said of the system:

“It’s designed to reduce overall IV complications including dislodgement, infiltration, phlebitis, and occlusion. Furthermore, its passive needle shielding technology and closed system is designed to minimize occupational exposure to blood.”

Born out of the University of Michigan’s Medical Innovation Center, Tangent Medical was founded in 2009. The company’s focus is in the development and commercialization of IV therapy products.