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
CINCINNATI, Ohio – 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.
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 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 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. Ethicon, Inc. and Ethicon Endo-Surgery, Inc. are part of the Johnson & Johnson Family of Companies. www.ethicon.com
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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.