FDA Approval for Covidien's iDrive - Analyst Blog

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Leading health care products company, Covidien plc. ( COV ) recently received 510(k) approval from the U.S. Food and Drug Association (FDA) for its iDrive Ultra powered stapling system. It is a first of its kind fully powered, battery-operated, reusable endoscopic stapler used during laparoscopic and open surgeries. The system will be available in the U.S. early in the fourth quarter of 2012.

The iDrive Ultra system is the latest offering from Covidien's Endomechanical Instruments under the Medical Devices business. Stapling products are already contributing to the growth of this business segment. The opportunity presented by this revolutionary powered stapling device with unique in-built features should be accretive to the company's top-line.

The iDrive Ultra system is the first stapler compatible with Covidien's entire range of Endo GIA reloads with Tri-Staple technology. The Tri-Staple technology integrated into the iDrive Ultra system enables better perfusion into the staple line, exerts lower pressure on tissue during compression and clamping and manages tissue variability effectively.

In addition, the iDrive Ultra system has been specifically designed for multi-patient use and is also environmentally friendly. With advanced features and extensive articulations, the system can be easily maneuvered without the application of manual firing force. All these special features will improve surgical precision and efficacy, resulting in better patient safety.

Covidien is a leading global health care products company with a history of developing high-quality products in a cost-effective manner. It competes with Johnson & Johnson ( JNJ ), Becton Dickinson ( BDX ) and C.R. Bard ( BCR ), among others. The company plans to bolster sales with the help of strategic acquisitions.

Covidien remains committed to rolling out new products and technologies, focusing on emerging markets, and boosting market share in core segments through investments in its sales and marketing infrastructure.

However, sustained pricing/procedure volume pressure, fluctuating foreign exchange rates, a sluggish U.S. and European economy represent major headwinds.  We currently have a Neutral recommendation on Covidien, which carries a short-term Zacks #4 Rank (Sell).


 
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: BCR , BDX , COV , JNJ

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