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Covidien plc (COV) Announces FDA 510(k) Clearance of LigaSure™ Small Jaw Instrument for Ear, Nose and Throat Surgical Procedures



9/11/2012 8:09:01 AM

BOULDER, Colo.--(BUSINESS WIRE)-- Covidien (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 LigaSure™ 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 surgeons’ needs by offering a low-temperature profile and minimal thermal spread to surrounding tissues.

The new clearance, for the device’s 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.

“This 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,” said Bryan Hanson, Group President, Surgical Solutions, Covidien. “LigaSure 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.”

LigaSure’s features received positive comments from surgeons during development as well as post-commercialization. “I confidently placed my finger immediately adjacent to the tips while sealing without feeling any significant heat,” said Dr. Thomas P. Rauth, a surgeon at Vanderbilt University Medical Center. “The importance of this cannot be stressed enough.” He also praised the device’s functionality, stating that “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 didn’t have to search for a foot control or second button to activate the current.1”

The LigaSure small jaw instrument provides an integrated cutting mechanism independent of sealing, leaving critical cutting decisions in the surgeon’s 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 ForceTriad™ 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 – 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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Contact:

Covidien

Marguerite Copel, 203-821-4720

Vice President, Communications

Surgical Solutions

marguerite.copel@covidien.com

or

Coleman Lannum, CFA, 508-452-4343

Vice President

Investor Relations

cole.lannum@covidien.com

or

John Jordan, 508-452-4891

Manager, Communications

Surgical Solutions

john.jordan@covidien.com

or

Todd Carpenter, 508-452-4363

Director

Investor Relations

todd.carpenter@covidien.com


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