Looking past recall, Covidien gets 510(k) for next-gen stapler

One week after recalling and discontinuing its Duet tissue-reinforcement device, Covidien ($COV) has won 510(k) clearance for the iDrive Ultra power stapler, used to seal surgical incisions.

The Ultra stapler follows Covidien's initial iDrive, launched in 2010, and the company says the new generation is the only fully-powered, reusable, battery-operated endoscopic surgical stapler on the market. Covidien plans to get the device on the market in the fourth quarter of this year, and a JPMorgan analyst told Reuters that the company will start to see a sales benefit next year.

That's good news for New Haven, CT-based devicemaker, which derives about 12% of its revenue from staplers and tissue-reinforcement techs. Last week, the company recalled and discontinued its Duet TRS system, used to reinforce staple lines in tissues after surgery. After three deaths and reports that the device can damage nearby tissues, Covidien called back all 540,000 units of Duet and halted its production.

Despite the ongoing trouble with Duet, Covidien reported double-digit sales increases among its stapler devices in the last quarter, contributing to a 4% net income jump.

The iDrive Ultra clearance wasn't Covidien's only positive regulatory news: The FDA also approved an extended-release 32-milligram version of Exalgo, a pain drug made by the company's pharma arm, Mallinckrodt, The Wall Street Journal reports. Last year, Covidien announced plans to spin off Mallinckrodt into a private company.

- read Covidien's release
- get more from Reuters
- read the Exalgo news from the WSJ (sub. req.)

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