Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson, has received FDA 510(k) clearance to expand the use of the ENSEAL Tissue Sealers to Ear, Nose and Throat (ENT) procedures. Both the first and second generation ENSEAL devices are covered under the expanded indication.
Ethicons’s ENSEAL line approved for ENT use includes the following:
- The G2 Super Jaw Tissue Sealer with a 22 cm shaft that is used for sealing large vessels upto 7mm. It has a curved jaw that allows for improved visualization and access to anatomies of interest. The G2 Super Jaw makes use of I-BLADE Technology to provide uniform compression force over the entire length of the jaws.
- The ENSEAL Trio Tissue Sealer with a 3mm curved jawn This sealer’s one step actuation allows for simultaneous sealing and transecting of vessels up to a 7mm diameter. Automatic temperature regulation technology in the ENSEAL Trio Tissue Sealer ensures minimal tissue damage during the sealing procedure.
- The ENSEAL Round Tip Tissue Sealer has features similar to the Trio Tissue Sealer but comes with a rounded tip. This sealer with a 5mm shaft and 360 degree rotation is used for bipolar coagulation and mechanical transection of tissue.
- The G2 Curved and Straight Tissue Sealers with a 3mm curved or 5mm straight jaws. This sealer is advertised by Ethicon as providing twice the compression force at the distal tip of the jaw, consistent seal strength and less sticking over multiple activations than competing products.
- The G2 Articulating Tissue Sealers allow for perpendicular access to vessels through 110° of articulation with 360° shaft rotation resulting in a stronger seal than when vessels are sealed with a 45 degree access.
Product page: ENSEAL…
Flashbacks: Ethicon ENSEAL G2 Cordless Tissue Sealer Gets U.S. Approval; Ethicon’s ENSEAL G2 Super Jaw Provides Improved Compression and Heat Delivery…; Ethicon’s ENSEAL G2 Articulating Tissue Sealer FDA Cleared…