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ICU Medical has chosen to remove the CLC2000 from the U.S. market rather than invest in an expensive study of an outdated technology.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

iOnTheMarket Premium
Advertisement

Advertisement


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

rss feed

Latest Stories

article imageChipotle Mexican Grill, Inc. (CMG) Q2 Earnings Preview: Will Higher Traffic Offset Higher Costs the Key

Chipotle Mexican Grill, Inc. (NYSE:CMG) will host a conference call to discuss second quarter 2014 read on...

article imageNetflix, Inc. (NFLX) Q2 Earnings Preview: The Ruby Month for a Reason

Netflix, Inc. (NASDAQ:NFLX) will post its second-quarter 2014 financial results and business outlook on its read on...

article imageLadenburg Thalmann Financial Services (NYSEMKT:LTS): Heavy, Durable Insider Buying

Ahh, but any worries over price levels didn’t stop multiple insiders at Ladenburg Thalmann Financial read on...

article imageInternational Business Machines Corp. (IBM) Q2 Earnings Preview: Small Beat and Pop

International Business Machines Corp. (NYSE:IBM) will host a conference call Wednesday, Jul. 16, 2014 at read on...

Advertisement
Popular Articles

Advertisement
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.