MANSFIELD – Covidien PLC has received 510(k) clearance from the U.S. Food and Drug Administration to use its LigaSure curved, small jaw, open sealer/divider in ear, nose and throat procedures.
The LigaSure, originally approved for general surgery, is now approved for use in head and neck procedures and will allow for additional uses including thyroidectomies, parotidectomies and other open ENT procedures.
The small jaw instrument provides an integrated cutting mechanism that is independent of sealing, leaving critical cutting decisions in the surgeon’s hands.
Originally, the LigaSure, which is sold worldwide, was 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,” Bryan Hanson, president of surgical solutions at Covidien, said in prepared remarks.
“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,” added Hanson.