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ENSEAL G2 Articulating - 510(k) Clearance

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Ethicon’s Articulating Advanced Energy Device Enables Surgeons to Achieve Stronger Sealing and Better Access

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Manufacturing Group February 10, 2013

To address surgeons’ need for strong sealing in tight spaces where access is limited, Ethicon Endo-Surgery Inc. officials announce the 510(k) clearance from the U.S. Food and Drug Administration (FDA) 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,” states Dr. Joe Amaral, chief scientific office, Ethicon. “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.”

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

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