ANN ARBOR — Tangent Medical Tuesday announced submission of a United States Food and Drug Administration 510(k) application for its NovaCath Secure IV Catheter System, developed from extensive clinical research of health care worker and patient needs.
This new closed IV catheter system is a next-generation technology designed to address several complex IV therapy challenges including catheter stabilization, occupational exposure to blood, and patient discomfort. When cleared by the FDA, the NovaCath system will be the first safety IV catheter offering advanced catheter stabilization technology designed to exceed the highest CDC, OSHA, and INS standards for peripheral IV catheter stabilization.
“The NovaCath Secure IV System is a promising new IV catheter designed to advance the safety and welfare of both patients and healthcare workers,” said Curtis Bloch, vice president of sales and marketing. “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. Several patent pending features will uniquely position the NovaCath System to offer healthcare facilities uncompromising safety — both to the clinician and the patient.”
Tangent Medical chairman and CEO Jeff Williams added: “The initial feedback on the NovaCath Secure IV Catheter System design has been extremely positive from both industry professionals and potential users. We are excited to announce NovaCath’s submission milestone and look forward to working with the FDA through the review process to gain 510(k) marketing clearance. The company has attracted an accomplished management team that is incredibly passionate about commercializing this innovative technology, which will be publicly unveiled for the first time in the coming weeks.”
Tangent Medical is focused on the development and commercialization of IV therapy products. Founded in 2009 as a spin-out of the University of Michigan’s Medical Innovation Center, the company’s patent-pending NovaCath Secure IV Catheter System is the only safety IV catheter to cost-effectively integrate advanced catheter stabilization, passive needle encapsulation and blood control. Based on extensive clinical research into the needs of both healthcare workers and patients, this next-generation system is designed to establish a new standard in catheter design, functionality and performance. For more information, visit www.tangentmedical.com.