Expanded indication for small jaw device provides valuable,
multifunctional tool for head and neck surgeons
BOULDER, Colo.--(BUSINESS WIRE)--Sep. 11, 2012--
(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, 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.
Learn more about the new U.S. FDA 510(k) clearance for use in ENT
procedures at: http://energysolutions.covidien.com/content/ppv-whats_new2.
1. The statements here reflect the views and opinion of Dr.
Rauth, and are not an endorsement from Vanderbilt University Medical
Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers
value through clinical leadership and excellence. Covidien manufactures,
distributes and services a diverse range of industry-leading product
lines in three segments: Medical Devices, Pharmaceuticals and Medical
Supplies. With 2011 revenue of $11.6 billion, Covidien has 43,000
employees worldwide in more than 65 countries, and its products are sold
in over 140 countries. Please visit www.covidien.com
to learn more about our business.
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Marguerite Copel, 203-821-4720
Lannum, CFA, 508-452-4343