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ECHELON ENDOPATH™ Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. ECHELON ENDOPATH™ Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, and colorectal procedures.

Echelon Endopath™ Staple Line Reinforcement is a staple line reinforcement, also known as a buttress, for use in the surgical environment for the purpose of reinforcing a staple line.

This submission is to increase the maximum sterilization dose from 25-30 kGy to 25-40 kGy and device Shelf-Life from 2 years to 3 years. There are no changes to the device itself associated with this submission.

Echelon Endopath™ Staple Line Reinforcement is to be used with surgical stapling devices. Surgical stapling devices place staggered rows of staples with a reinforcement material and simultaneously divide the tissue and the reinforcement material between the stapled rows.

The Subject Device is an absorbable staple line reinforcement material which is secured to both the stapler anvil and reload with a synthetic attachment material. The product consists of an applicator which includes the implantable device, one for each of the upper and lower stapler jaws. The implantable material consists of 3 materials: the Vicryl material, the Polydioxanone film and the attachment adhesive material.

Echelon Endopath™ Staple Line Reinforcement is an implanted material which works as an adjunct to surgical staples after transection, to provide support to soft tissue during the healing process. There are no modifications to the design of the Predicate device; and the materials of the Subject Device and Predicate Device are the same. Each unit is packaged sterile in separate pouch.

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