Join        Login             Stock Quote

ICU Medical (ICUI) To Discontinue Positive Displacement Technology Sale On FDA Concerns

 January 28, 2013 09:54 AM

(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.

[Related -Stock Upgrades And Downgrades: AWK, BLK, ICUI, MGM, RAX, TSLA, VSAT]

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ICU Medical has chosen to remove the CLC2000 from the U.S. market rather than invest in an expensive study of an outdated technology.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.

[Related -Stamps.Com Is A Standout Performer For The Crabtree Technology Model]

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.



Post Comment -- Login is required to post message
Alert for new comments:
Your email:
Your Website:

rss feed

Latest Stories

article imageHas Warren Buffett Found The Best Investment In Oil?

Shares of oil stocks plunged again as the price of West Texas Intermediate wiped out nearly half of its read on...

article imageDemand For Safe-Haven Bonds Surged Last Week

The crowd piled into investment-grade bonds last week as economic worries triggered an exodus out of risky read on...

article imageThoughts on MetLife and AIG

In some ways, this is a boring time in insurance investing.  A lot of companies seem cheap on a book and/or read on...

article imageA 2016 Recession Would Be Different

If the US or the Eurozone entered a recession this year, a few macroeconomic variables would look very read on...

Popular Articles

Daily Sector Scan
Partner Center

Related Articles:

Volume Up As Week Ends; DHX And BJRI Breakout
More Articles on: Medical

Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.