Ethicon Receives 510(k) Clearance for New HARMONIC FOCUS®+ Shears with Adaptive Tissue Technology

  Ethicon Receives 510(k) Clearance for New HARMONIC FOCUS®+ Shears with
  Adaptive Tissue Technology

Adaptive Tissue Technology empowers surgeons to handle multiple surgical jobs
 with greater precision, building on the strong, innovative foundation of the
               uniquely designed HARMONIC^® Energy product line

Business Wire

CINCINNATI -- December 11, 2013

In an effort to drive greater efficiency in surgery, Ethicon Endo-Surgery,
Inc. (Ethicon) today announces that HARMONIC FOCUS^®+ Shears with Adaptive
Tissue Technology (HARMONIC FOCUS^®+) has received 510(k) clearance from the
U.S. FDA. The HARMONIC FOCUS^®+ is a next generation ultrasonic surgical
device that now brings Adaptive Tissue Technology to open procedures while
delivering on the HARMONIC^® promise of precision. This is the fifth 510(k)
clearance for the Ethicon Energy portfolio this year.

HARMONIC FOCUS+ Shears with Adaptive Tissue Technology (Photo: Business Wire)

HARMONIC FOCUS+ Shears with Adaptive Tissue Technology (Photo: Business Wire)

The new HARMONIC FOCUS^®+ leverages the proprietary Adaptive Tissue Technology
that was originally introduced in HARMONIC ACE^®+ earlier this year. This
technology enables the system to actively sense and adapt to changing tissue
conditions and intelligently deliver energy resulting in improved performance
with superior precision. In addition, the new slimmer profile is designed to
increase speed and visibility, as well as improved dissection.

“I currently use HARMONIC FOCUS as it provides a number of novel utilities in
my surgical practice beyond traditional utility in thyroid surgery. The
instrument allows for hemostatic resection with minimal blood loss. There is
also a marked minimal thermal spread which can impact on interpretation of
surgical margins,” said Dr. Dennis Kraus, MD, Otolaryngology, North Shore-LIJ
Cancer Institute, New York, NY.“With the enhanced precision that comes with
the Focus+ Shears, it has the potential to eliminate the need for instrument
exchanges and further improve my operative efficiency.”

HARMONIC FOCUS^®+ is designed for use in numerous procedures and specialties
including ENT and General, enhancing surgeons’ ability to handle multiple jobs
with superior precision.

HARMONIC FOCUS^®+ is the latest example of our commitment to developing
meaningful innovations that can help improve outcomes in critical procedures,”
says Tom O’Brien, Ethicon Vice President, Energy Global Strategic Marketing.
“As we move toward the future, our Adaptive Tissue Technology will serve as a
platform for developing a portfolio of HARMONIC^® devices that offer even
greater functionality and benefits, providing surgeons increased choice and
the flexibility to meet their diverse set of clinical needs for their patients
and procedures.”

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

HARMONIC^® ultrasonic devices combine precision and multifunctionality:
Uniquely designed for precise dissection, sealing and transection, one device
enables surgeons to perform multiple jobs without instrument exchanges.
HARMONIC^® technology is the proven leader in advanced energy with more than
16 million procedures worldwide^1. Devices in the HARMONIC^® portfolio are
used for open and laparoscopic procedures that require precision. The
portfolio can be used across a range of surgical specialties: General,
Colorectal, Bariatric, Vascular, Gynecology, ENT, Urology, Thoracic, and
Plastic and Reconstructive. Click here to learn more.

ENSEAL^® Tissue Sealers consistently cut and seal vessels up to and including
7mm through high uniform compression. Devices in the ENSEAL^® portfolio are
intended for use during both open and laparoscopic surgical procedures where
division of vessels, lymphatics and tissue bundles is performed. These
surgical specialties include: General, Colorectal, Bariatric, Gynecology,
Thoracic, Plastic and Reconstructive, Urology, and ENT. Click here to learn

About Our Company
Ethicon, Inc. and Ethicon Endo-Surgery, Inc., two companies with long
histories of medical innovation, do business under the Ethicon brand. Their
surgical technologies and products (including sutures, staplers, energy
devices, clip appliers, trocars and meshes) are used around the world to treat
colorectal and thoracic conditions, women’s health conditions, hernias, cancer
and obesity. Ethicon, Inc. and Ethicon Endo-Surgery, Inc. are part of the
Johnson & Johnson Family of Companies. Learn more at, or
follow us on Twitter @Ethicon.

Safe Harbor Statement
This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. The reader is cautioned not
to rely on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results could
vary materially from the expectations and projections of Ethicon, Inc.,
Ethicon Endo-Surgery, Inc. or Johnson & Johnson. Risks and uncertainties
include, but are not limited to, general industry conditions and competition;
economic factors, such as interest rate and currency exchange rate
fluctuations; technological advances, new products and patents attained by
competitors; challenges inherent in new product development, including
obtaining regulatory approvals; challenges to patents; changes in behavior and
spending patterns or financial distress of purchasers of health care products
and services; changes to governmental laws and regulations and domestic and
foreign health care reforms; trends toward health care cost containment; and
increased scrutiny of the health care industry by government agencies. A
further list and description of these risks, uncertainties and other factors
can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K
for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well
as subsequent filings, are available online at, or on
request from Johnson & Johnson. None of Ethicon, Inc., Ethicon Endo-Surgery,
Inc. or Johnson & Johnson undertakes to update any forward-looking statement
as a result of new information or future events or developments.


^1  Internal sales data as of June 10, 2013.
     Dr. Kraus is a paid consultant for Ethicon

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Energy Worldwide Communications
Bridgett Golden, 513-375-9524
Ann Leibson, 513-479-1210
Follow us on Twitter @Ethicon
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