Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for an expanded indication of ear, nose and throat (ENT) procedures for the ENSEAL tissue sealers.
The FDA 510(k) approval covers both the first and second generation devices that include ENSEAL trio, ENSEAL round tip, ENSEAL G2 curved tissue sealer, and ENSEAL G2 straight tissue sealers.
Ethicon Endo-Surgery worldwide energy surgical science vice president Dr Joe Amaral noted that every patient and every surgery is unique.
"With that in mind we continue to strive to offer surgeons the best in both advanced bipolar and ultrasonic so they can choose the device best suited to improve outcomes for their patients," Dr Amaral added.
The new indication allows surgeons to choose their ENT surgical device from either the ENSEAL portfolio or HARMONIC portfolio.
The HARMONIC ultrasonic devices include the HARMONIC SYNERGY blades and the HARMONIC FOCUS curved shears.
Through high uniform compression, the ENSEAL tissue sealers consistently cut and seal vessels up to and including 7mm.
Devices in the ENSEAL portfolio can be used for both open and laparoscopic surgical procedures where division of vessels, lymphatics and tissue bundles is performed.
These surgical procedures include general, colorectal, bariatric, gynecology, thoracic, plastic and reconstructive, urology, and ENT.
Devices in the HARMONIC portfolio can be used for both open and laparoscopic procedures including general, colorectal, bariatric, vascular surgery, gynecology, ENT, urology, thoracic, and plastic and reconstructive.