FDA Nod For Ethicon Endo’s ENSEAL® G2 Articulating Tissue Sealer

In short

Ethicon Endo-Surgery, Inc. has announced the FDA 510(k) clearance of its “ENSEAL® G2 Articulating” bipolar tissue sealing system. The company says this device addresses surgeons’ need for strong sealing in tight spaces where access is limited

Background

One of the big challenges surgeons face when performing colorectal, gynecological and general surgeries is operating in challenging anatomy. Ethicon says its articulating system is designed to help surgeons manoeuvre 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.

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 reputedly stronger than those sealed at oblique angles, thereby reducing the likelihood of internal bleeding and post-surgery complications.

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 minimising 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 minimise thermal spread.

Other bipolar devices do not have the Positive Temperature Coefficient technology and offset electrode configuration designed for minimising energy spread into surrounding tissue.

Physician comments

“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, and a paid consultant to Ethicon. “For my oncology patients, I anticipate that it will help in the tight spots where access is limited and making procedures smoother.”

Company comments 

“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.”

Source: Ethicon Endo-Surgery, Inc., Business Wire