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FDA clears IV catheter system

By: Mike Verespej

September 17, 2012

ANN ARBOR, MICH. (Sept. 17, 8:45 a.m. ET) — A new IV catheter system designed to minimize the risk of needle-stick injuries and occupational exposure to blood has received market clearance from the Food and Drug Administration.

IV therapy products manufacturer Tangent Medical Technologies announced Sept. 13 that FDA has approved its NovaCath Secure IV Catheter System. The NovaCath system integrates a series of next-generation technologies designed to address IV therapy challenges including catheter stabilization, healthcare worker safety, tubing management and patient comfort.

“Up to 50 percent of all short-peripheral IV catheters develop complications that negatively impact catheter dwell times, clinical outcomes, patient safety and patient satisfaction,” said Curtis Bloch, vice president of sales and marketing for the Ann Arbor, Mich., company that was founded in 2009 as a spin-out of the University of Michigan’s Medical Innovation Center.

“Our innovative, closed IV catheter design uniquely integrates advanced catheter stabilization, next generation tubing management, passive needle encapsulation, and blood control on every short-peripheral IV start,” Bloch said. “The FDA clearance will pave the way for us to advance the safety and efficacy of IV therapy.”

In addition, NovaCath’s integrated advanced catheter stabilization technology can eliminate an external ‘j-loop’ based on its redirect of the fluid path internal to the device, said Tangent.

“Clinicians were quick to point out the novel design and benefits it would bring the practice of IV therapy, as well as patient and clinician safety,” said Tangent CEO and Chairman Jeff Williams.