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Ethicon Receives 510(K) Clearance for ENSEAL® G2 Cordless

  Ethicon Receives 510(K)Clearance for ENSEAL® G2 Cordless

   First of its Kind, Ready-to-Use Cordless Advanced Bipolar Energy Device
     Maintains Superior Sealing Benefits of ENSEAL^® Tissue Sealers While
                          Simplifying Set Up and Use

Business Wire

CINCINNATI -- March 20, 2013

In an effort to continue improving physician experience, while helping to
simplify the operating room, Ethicon Endo-Surgery, Inc. (Ethicon) today
announces the 510(k) clearance from the U.S. Food and Drug Administration for
the ENSEAL^® G2 Cordless Tissue Sealer Device. The ready-to-use cordless
design allows surgeons a new option for procedures where speed and range of
motion may be critical. This self-contained device includes the generator and
power source so no assembly is required which allows for quick procedure
set-up. Furthermore, the cordless feature removes the potential for tangled
cords while multiple instruments are in use.

ENSEAL G2 Cordless (Photo: Business Wire)

ENSEAL G2 Cordless (Photo: Business Wire)

ENSEAL^® G2 Cordless builds on an already wide portfolio of advanced bipolar
tissue sealers, offering surgeons more choices to find the best fit for their
procedures and patients. ENSEAL^® G2 Cordless offers the same unique superior
sealing* benefits of the ENSEAL^® portfolio by providing uniform compression,
controlling temperature and minimizing thermal spread – now in a cordless
ready to use design. ENSEAL^® technology is used in a wide range of
colorectal, gynecological, bariatric and general surgeries.

“I get the same superior sealing that I rely on from the ENSEAL^® technology,
with the added benefits of no set up or interruptions from potential cord
tangles,” says James Dana Kondrup, MD, Department of OB/GYN, Upstate Medical
Center Syracuse NY, Binghamton Campus. “This allows my team and me to stay
completely focused on the surgery.”

“As healthcare delivery evolves, Ethicon is committed to providing surgeons
more choices to meet the unique needs of their patients and procedures, while
reducing complexity and helping to reduce cost,” said Dr. Joe Amaral, Ethicon
Chief Scientific Officer. “We see cordless as one of the advances that
delivers on this commitment.”

About Our Energy Business

Ethicon is a leader in advanced energy solutions and offers the broadest
portfolio of ultrasonic energy devices using HARMONIC^® technology and
advanced bipolar energy devices using ENSEAL^® technology. Click here to learn
more.

HARMONIC^® ultrasonic devices combine precision and multifunctionality: With a
jaw and blade uniquely designed for precise dissection, sealing and
transection, one device enables surgeons to perform multiple jobs without
instrument exchanges. HARMONIC^® is used in more than 14 million surgical
procedures annually around the world. Click here to learn more.

ENSEAL^® advanced bipolar devices are strong on sealing, yet gentle on tissue.
With an I-BLADE^® that delivers high uniform compression along the entire
length of the jaw, ENSEAL^® seals vessels up to 7mm in diameter. The G2 line
also includes the ENSEAL^® G2 Super Jaw device, launched in 2011, and the
ENSEAL^® G2 Curved and Straight Tissue Sealers, launched in 2012. Click here
to learn more.

About Our Company

The ETHICON brand is used for the products of Ethicon, Inc. and Ethicon
Endo-Surgery, Inc., two companies with long histories of medical innovation,
which provide globally a broad range of surgical technologies and products
(including energy devices, sutures, staplers, clip appliers, trocars and
meshes) used to treat colorectal and thoracic conditions, women’s health
conditions, hernias, cancer and obesity. www.ethicon.com

Dr. James Dana Kondrup is a consultant for Ethicon and receives compensation
for his services.

* Enseal G2 Cordless device demonstrated seal burst pressures greater than 240
mmHg with 0.804 reliability at 95% confidence with no demonstrated difference
(p = 0.9525) to the burst pressure values of 10 ETRIO devices on vessels
6.0-7.5mm.

* Enseal G2 demonstrated seal burst pressures greater than 240 mmHg with 0.883
reliability at 95% confidence with demonstrated higher burst pressure values
(p = 0.010) than 10 ETRIO devices on vessels 4.5-7.5mm.

Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20130320005315/en/

Multimedia
Available:http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50594148&lang=en

Contact:

Ethicon
Bridgett Golden, 513-375-9524
bgolden@its.jnj.com
or
Ann Leibson, 513-479-1210
aleibso@its.jnj.com