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BOULDER, Colo.--([ BUSINESS WIRE ])--[ Covidien ] (NYSE: COV), a leading global provider of healthcare products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the [ LigaSurea" curved, small jaw, open sealer/divider ] surgical instrument to be used in ear, nose and throat (ENT) procedures. When working in confined surgical spaces, the proprietary LigaSure device addresses surgeonsa needs by offering a low-temperature profile and minimal thermal spread to surrounding tissues.

"the ergonomics of the device are outstanding. The hand activation with the closing of the instrument is a simple, yet brilliant, concept. It sped up the operation since I didnat have to search for a foot control or second button to activate the current.1"

The new clearance, for the deviceas use in head and neck procedures, will allow for additional uses such as [ thyroidectomies ], parotidectomies and additional open ENT procedures. There are more than 160,000 of these procedures performed each year in the United States. The LigaSure small jaw instrument, sold worldwide, was previously cleared for use in general surgery by the FDA in February 2011.

aThis is a major milestone in recognizing the LigaSure small jaw instrument as an effective open surgical device and significantly expands its use throughout the surgical community. We believe surgeons will see it as a valuable tool for ENT procedures,a said Bryan Hanson, Group President, Surgical Solutions, Covidien. aLigaSure technology has set the industry standard in vessel sealing since 1998. This technology has been used in millions of surgical procedures worldwide and is supported by an every growing body of evidence-based research.a

LigaSureas features received positive comments from surgeons during development as well as post-commercialization. aI confidently placed my finger immediately adjacent to the tips while sealing without feeling any significant heat,a said Dr. Thomas P. Rauth, a surgeon at Vanderbilt University Medical Center. aThe importance of this cannot be stressed enough.a He also praised the deviceas functionality, stating that athe ergonomics of the device are outstanding. The hand activation with the closing of the instrument is a simple, yet brilliant, concept. It sped up the operation since I didnat have to search for a foot control or second button to activate the current.¹a

The LigaSure small jaw instrument provides an integrated cutting mechanism independent of sealing, leaving critical cutting decisions in the surgeonas hands. Its multifunctional design also provides for blunt dissection and an enhanced experience for the surgeon, especially in confined surgical spaces. LigaSure technology, powered by the [ ForceTriada" energy platform ], gives surgeons a continuous output of energy, monitoring the tissue and making real-time adjustments 3,333 times/second to seal vessel walls.

The product will be showcased this year at the American College of Surgeons Annual Clinical Congress, to be held September 30 a" October 4 in Chicago, IL. Surgeons are invited to booth 1819 to further explore the benefits of the LigaSure small jaw instrument.

Learn more about the new U.S. FDA 510(k) clearance for use in ENT procedures at: [ http://energysolutions.covidien.com/content/ppv-whats_new2 ].

1.The statements here reflect the views and opinion of Dr. Rauth, and are not an endorsement from Vanderbilt University Medical Center.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 43,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit [ www.covidien.com ] to learn more about our business.

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