US-based Tangent Medical has received CE Mark approval for the NovaCath Integrated IV Catheter System.
The approval shows that NovaCath meets the safety, health and environmental requirements in the European Union (EU) and clears the company to launch the product across Europe and other countries recognising the CE Mark.
Tangent Medical president Eric Sandberg said that this is another significant milestone for the company and allows the initiation of selling NovaCath in Europe.
"NovaCath is a breakthrough technology designed to address IV therapy challenges common throughout the world," Sandberg said.
"Receiving CE Mark approval gives us the opportunity to advance the safety and efficacy of IV therapy for patients, clinicians, and hospitals in additional international markets."
NovaCath Integrated IV Catheter System includes a series of next-generation technologies designed to address IV therapy challenges such as catheter stabilisation, healthcare worker safety, tubing management and patient comfort.
It is the only peripheral IV catheter with advanced catheter stabilisation designed to exceed the highest CDC, OSHA and INS standards for IV catheter stabilisation.
The system’s passive needle shielding technology and closed system design reduces risk of needlestick injuries and occupational exposure to blood to the lowest feasible extent.
Tangent Medical vice-president of sales and marketing Curtis Bloch said NovaCath integrates several patented design elements that not only reduce the risk of IV complications, but also improve healthcare worker safety and clinical efficiency.
"Our innovative, award-winning design delivers advanced catheter stabilisation, next-generation tubing management, passive needle encapsulation and blood control on every short-peripheral IV start," Bloch said.