Reuters: Regulatory News: Covidien wins U.S. FDA clearance for surgical stapler system

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Covidien wins U.S. FDA clearance for surgical stapler system Aug 28th 2012, 11:36 Tue Aug 28, 2012 7:36am EDT Aug 28 (Reuters) - Covidien Plc said on Tuesday that it had won clearance from the U.S. Food and Drug Administration for its iDrive Ultra powered stapling system, a tool used during surgery. This comes a week after the medical device and products maker recalled its Duet product, which was used to reinforce tissues after stapling. After reports of complications, Covidien said it would stop manufacturing the product. The new iDrive stapling system will be on the U.S. market in the fourth quarter, the company said. It is the only fully powered, reusable, battery-operated endoscopic surgical stapler on the market, it added. Covidien's stapler products account for 12 percent to 13 percent of total company revenue, according to JPMorgan analyst Michael Weinstein. He said the company should start to benefit from the introduction of the iDrive in 2013.

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