(By Balaseshan) ICU Medical Inc. (NASDAQ: ICUI) said it will voluntarily discontinue U.S. distribution of the CLC2000 Positive Displacement Needlefree Connector effective April 30, 2013 due to concerns from the U.S. Food and Drug Administration (FDA).
FDA concerns over the safety of positive displacement connectors coupled with increasing market demand for its newer technologies leads ICU Medical to discontinue U.S. sales of the 16-year-old CLC2000 technology, the company noted.
The CLC2000 will continue to be available for purchase in markets outside the United States. The company said it is facing sharply decreasing U.S. sales volumes as customers are switching to its newer, clinically superior needlefree connector technologies.
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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.
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ICU Medical has chosen to remove the CLC2000 from the U.S. market rather than invest in an expensive study of an outdated technology.
The 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.
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The Neutron Catheter Patency Device is 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.
ICUI is trading down 0.11% at $63.84 on Monday. The stock has been trading between $43.51 and $64.03 for the past 52 weeks.