J&J's Ethicon gets FDA OK on new tissue sealer
|Ethicon snagged 510(k) clearance for its Enseal G2 tissue sealer--courtesy of Ethicon|
The G2 is the first articulating advanced energy device designed to allow surgeons to take a perpendicular approach to seal vessels, the company said. That comes in handy in colorectal, gynecological and other surgeries in which anatomy presents a challenge to surgeons trying to close up incisions.
And the angle of approach can make all the difference: Vessels sealed perpendicularly are stronger than those closed from oblique angles, Ethicon says, and stronger sealing means lower risk of internal bleeding and repeat surgery.
The energy-based device uses Ethicon's I-Blade technology, which the company says can seal tissues with uniform compression while controlling temperature and minimizing thermal spread. Using proprietary offset electrode configuration technology, the device can hone its energy with little to no errant heat.
Ethicon, J&J's surgical device unit, has struggled with recalls over the past year, facing a Class I in October over its Proximate hemorrhoidal staplers and launching a voluntary recall of wound-draining products in March. But, as J&J's growing surgical revenue demonstrates, Ethicon has weathered regulatory woe, and the parent company has committed $185 million to expand Ethicon's Athens, GA, suture-making plant.
- read the announcement
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