Ethicon Receives 510(k) Clearance for ENSEAL® G2 Articulating

  Ethicon Receives 510(k) Clearance for ENSEAL® G2 Articulating

  First of its Kind Articulating Advanced Energy Device Enables Surgeons to
                  Achieve Stronger Sealing and Better Access

Business Wire

CINCINNATI -- February 4, 2013

To address surgeons’ need for strong sealing in tight spaces where access is
limited, Ethicon Endo-Surgery, Inc. (Ethicon) today announces the 510(k)
clearance from the U.S. Food and Drug Administration for the ENSEAL^® G2
Articulating Tissue Sealer. ENSEAL^® G2 Articulating is the first articulating
advanced energy device designed to allow surgeons to take a perpendicular
approach to seal vessels up to 7mm in diameter and lymphatics through a 5mm
port. Vessels sealed perpendicularly are stronger than those sealed at oblique
angles.* Stronger sealing helps reduce the likelihood of internal bleeding and
post-surgery complications.

ENSEAL G2 Articulating (Photo: Business Wire)

ENSEAL G2 Articulating (Photo: Business Wire)

One of the big challenges surgeons face when performing colorectal,
gynecological and general surgeries is operating in challenging anatomy.
ENSEAL^® G2 Articulating will help surgeons maneuver around corners and behind
structures in the body, and provide better access to tissue in deep or tight
spaces for greater control of the angle of approach to vessels.

“The articulation helps give me a perpendicular angle on vessels which gives
me a strong seal in one bite,” says Steven A. Elg, M.D., GYN Oncologist, Iowa
Methodist. “For my oncology patients, I anticipate that it will help in the
tight spots where access is limited and making procedures smoother.”

ENSEAL^® G2 Articulating builds on the unique benefits of the ENSEAL^®
portfolio, which is designed for superior tissue sealing by providing uniform
compression, controlling temperature and minimizing thermal spread. The
Proprietary I-BLADE^® technology delivers high uniform compression for sealing
vessels consistently along the length of the jaw. The proprietary offset
electrode configuration device is designed to minimize thermal spread. Other
bipolar devices do not have the Positive Temperature Coefficient technology
and offset electrode configuration designed for minimizing energy spread into
surrounding tissue.

“ENSEAL^® G2 Articulating builds on an existing portfolio of advanced bipolar
tissue sealers designed to give surgeons confidence and choice in surgery,”
said Dr. Joe Amaral, Ethicon Chief Scientific Officer. “Ethicon continues to
work with surgeons around the world and across specialties to design
innovations to help surgeons deliver the best outcomes based on the unique
needs of 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: 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 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

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. Ethicon, Inc. and Ethicon
Endo-Surgery, Inc. are part of the Johnson & Johnson Family of Companies.

Dr. Steven A. Elg is a paid consultant for Ethicon Endo-Surgery.

*Compared to a non-articulating device. Based on a benchtop burst pressure
study number PRC051608.

Photos/Multimedia Gallery Available:



Ethicon Endo-Surgery, Inc.
Bridgett Golden, 513-375-9524
Ann Leibson, 513-479-1210
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