FDA Clears Covidien’s LigaSure™ Small Jaw Sealer/Divider For ENT Use

In short

Covidien has announced that it has received 510(k) clearance from the U.S. FDA for its LigaSure™ curved, small jaw, open sealer/divider surgical instrument to be used in ear, nose and throat (ENT) procedures. Covidien says its proprietary device offers a low-temperature profile and minimal thermal spread to surrounding tissues, important when working in the confined surgical spaces often encountered in ENT procedures.

Background

Covidien’s LigaSure small jaw instrument, sold worldwide, was previously cleared for use in general surgery by the FDA in February 2011. It provides an integrated cutting mechanism independent of sealing, leaving critical cutting decisions in the surgeon’s hands. The technology is powered by the ForceTriad™ energy platform which the company says gives surgeons a continuous output of energy, monitoring the tissue and making real-time adjustments 3,333 times/second to seal vessel walls.

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, of which there are more than 160,000 performed each year in the United States.

Company comments

“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.”

Clinician comments

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”

Source: Covidien, Business Wire