|ICU Medical is pulling its CLC2000 after 16 years on the U.S. market--courtesy of ICU Medical|
ICU Medical ($ICUI) is pulling its CLC2000 Positive Displacement Needle-Free Connector off the U.S. market, responding to slumping demand and FDA concerns about infection risk.
The devices have been on the market for 16 years, ICU says, but, in 2010, the FDA warned customers of the risk of hospital-borne infection with positive displacement devices, requiring detailed post-market surveillance from devicemakers and torpedoing demand for the technology.
At the same time, ICU's own MicroClave Clear and Neutron Catheter Patency Device have overtaken CLC2000 and can serve the same function without the risk, and the company has chosen to phase out its old standby rather than undertake an expensive study, Vice President of Sales Richard Costello said in a statement.
When it launched, CLC2000 was the first device of its kind on the market and the first connector ever developed specifically to help maintain catheter patency, ICU says. And while the device's removal marks the end of a long-running revenue source for the company, ICU is less dependent on connectors, having expanded its offerings into oncology, patient monitoring and critical care technologies.
The CLC2000 will remain available outside the U.S.
- read ICU's statement