ICU Medical, Inc. ICUI today announced it will voluntarily discontinue U.S. distribution of the
CLC2000® Positive Displacement Needlefree Connector effective April 30, 2013
due to FDA concerns over the safety of positive displacement needlefree
connectors and sharply decreasing U.S. sales volumes caused by customers
switching to the company's newer, clinically superior needlefree connector
technologies. The CLC2000 will continue to be available for purchase in
markets outside the United States.
Launched over a decade and a half ago, CLC2000 was the first positive
displacement needlefree connector on the market and the first connector ever
developed specifically to help maintain catheter patency. Today, this positive
displacement technology has largely been replaced in the U.S. by clinicians
choosing the neutral displacement features of the MicroClave^® Clear and, more
recently, the anti-reflux technology of the Neutron™ Catheter Patency Device,
the first and only FDA-cleared device shown to significantly reduce all types
of reflux into a catheter and be cleared for use on all patients, including
pediatric and immunocompromised patients.
In addition, FDA concerns regarding the safety of positive displacement
needlefree connectors prompted the agency to require manufacturers to perform
extensive post-market surveillance of these devices.^1 Given the decreasing
demand for the CLC2000 and the ready availability of its clinically superior
needlefree technology options, ICU Medical has chosen to remove the CLC2000
from the U.S. market rather than invest in an expensive study of an outdated
technology.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Posted In: News
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in