Tangent Medical has gained FDA 510(k) clearance for the NovaCath Secure IV Catheter System designed to address peripheral IV challenges including catheter stabilization, healthcare worker safety, tubing management and patient comfort.
The NovaCath Secure IV Catheter System integrates a series of next-generation technologies to address IV therapy challenges for clinicians and patients.
Tangent Medical sales and marketing vice president Curtis Bloch said up to 50% of all short-peripheral IV catheters develop complications that negatively impact catheter dwell times, clinical outcomes, patient safety and patient satisfaction.
"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 added.
"Our research with clinicians has validated there is nothing like it in the market. FDA clearance will pave the way for us to advance the safety and efficacy of IV therapy."
The peripheral IV catheter with advanced catheter stabilization was designed to exceed the highest CDC, OSHA and INS standards for IV catheter stabilization, according to the company.
The device with closed system design leverages passive needle shielding technology to minimize the risk of needlestick injuries and occupational exposure to blood to the lowest feasible extent.
"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 Jeff Williams, Tangent Medical’s CEO and Chairman.