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Covidien Gets FDA 510(k) Clearance For LigaSure Small Jaw, Open Sealer/divider

Covidien Ltd. (COV) said it secured 510(k) clearance from the U.S. Food and Drug Administration, or FDA, for the LigaSure curved, small jaw, open sealer/divider surgical instrument to be used in ear, nose and throat procedures.

According to the company, 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 LigaSure small jaw instrument provides an integrated cutting mechanism independent of sealing, leaving critical cutting decisions in the surgeon's hands.

In addition, LigaSure small jaw instrument's multifunctional design 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.

Covidien noted that 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.

by RTT Staff Writer

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