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Covidien (COV) Receives 510(K) Clearance For Ligasure Instrument In ENT Procedures

 September 11, 2012 08:23 AM
 

(By Balaseshan) Covidien Plc (NYSE:COV), a provider of healthcare products, announced 510(k) clearance from the U.S. regulatory authorities for LigaSure small jaw instrument to be used in ear, nose and throat (ENT) surgical procedures.

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 U.S. Food and Drug Administration (FDA) in February 2011.

When working in confined surgical spaces, the LigaSure curved, small jaw, open sealer/divider surgical device addresses surgeons' needs by offering a low-temperature profile and minimal thermal spread to surrounding tissues.

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 to October 4 in Chicago, IL.

COV closed Monday's regular session down 0.61% at $56.79. The stock has been trading between $41.35 and $57.86 for the past 52 weeks.


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