Covidien has announced FDA 510(k) clearance of its LigaSure small jaw surgical instrument for use in head and neck procedures.
The expanded indication for the LigaSure curved, open sealer/divider surgical instrument enables its use for ear, nose and throat surgical procedures.
The device provides an integrated cutting mechanism independent of sealing, and offers a low-temperature profile and minimal thermal spread to surrounding tissues.
Covidien surgical solutions group president Bryan Hanson said with the FDA clearance will significantly expand LigaSure’s use throughout the surgical community.
"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," Hanson said.
The FDA had previously cleared LigaSure for use in general surgery, while the new clearance will allow for additional uses such as thyroidectomies, parotidectomies and additional open ENT procedures.
Vanderbilt University Medical Center surgeon Dr Thomas Rauth said; "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."
LigaSure technology, powered by the ForceTriad energy platform, gives surgeons a continuous output of energy, monitoring the tissue and making adjustments 3,333 times a second to seal vessel walls, according to Covidien.
Image: The LigaSure small jaw instrument provides an integrated cutting mechanism independent of sealing, leaving critical cutting decisions in the surgeon’s hands. Photo: Courtesy of Business Wire.