Covidien’s LigaSure Small Jaw Instrument Now for Open ENT Procedures

Covidien’s LigaSure Small Jaw Instrument Now for Open ENT Procedures

BOULDER, Colo.–(BUSINESS WIRE)–Sep. 11, 2012– Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LigaSure™ curved, small jaw, open sealer/divider surgical instrument to be used in ear, nose and throat (ENT) procedures. 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, l …

The LigaSure small jaw instrument provides an integrated cutting mechanism independent of sealing, leaving critical cutting decisions in the surgeon’s hands. (Photo: Business Wire)

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 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,” 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.”

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”

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 – October 4 in Chicago, IL. Surgeons are invited to booth 1819 to further explore the benefits of the LigaSure small jaw instrument.

Overview

Sealer/divider

Hand or foot activation

Fuses vessels, including pulmonary vasculature, up to and including 7 mm in size, lymphatics and tissue bundles

Approximately 2 to 4 second seal cycle

May reduce the exchange of instruments compared to mechanical ligation

Compatible with the ForceTriad™ energy platform only, v 3.4 or greater

Procedures

General procedures

Plastic/reconstructive procedures

Urologic procedures

Thoracic procedures

Covidien has received 510(k) clearance from the FDA for the firm’s LigaSure Curved, Small Jaw, Open Sealer/Divider, a device used in general surgery. It will be available in the US later this quarter.

The LigaSure Curved, Small Jaw, Open Sealer/Divider, the newest addition to the LigaSure family of advanced surgical cutting/sealing devices, provides an integrated cutting mechanism independent of sealing, leaving the critical cutting decisions in the hands of the surgeon. Its multi-functional design also provides for blunt dissection and an enhanced, more efficient experience for the surgeon, especially in confined surgical spaces. A primary feature of this new LigaSure device is a low-temperature profile and minimal thermal spread to surrounding tissues.

The proven LigaSure technology, powered by the ForceTriadTM energy platform, provides surgeons with a continuous output of energy, monitoring the tissue and making real-time adjustments 3,333 times/second to seal vessel walls.

Source : http://investor.covidien.com/phoenix.zhtml?c=207592&p=irol-newsArticle&ID=1733818&highlight=

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