Ethicon Endo-Surgery, LLC received FDA approval for the Echelon Endopath Staple Line Reinforcement on 10/14/2019.
The Echelon Endopath Staple Line Reinforcement is an absorbable, synthetic buttress material intended to be used with the Echelon family of 60 mm endoscopic linear staplers for the purpose of reinforcing surgical staple lines. The individually packaged device consists of an applicator for the staple reload and the reinforcement which consists of Vicryl, a Polydioxanone (PDO) film, and the attachment material. These materials degrade via hydrolysis and are absorbed in 120 days. The Echelon Endopath GST60 mm reload places staggered rows of titanium staples with the reinforcement material, and simultaneously divides the tissue. The Echelon Endopath reinforcement has improved coverage over the staples when compared to predicate reinforcement devices.
As with other staple line reinforcements, the Echelon Endopath reinforcement serves as an adjunct to surgical staples after transection by providing support to soft tissue during the healing process. The Echelon Endopath offers quick loading and delivery. Due to a simpler click and go application, there is a significant reduction in the number of steps to prepare the reinforcement, which ultimately results in less preparatory time. Rather than a sleeve construction with suture pullcord in some other predicate devices, the Echelon Endopath reinforcement utilizes a thin adhesive that readily attaches to the staple reload. By reducing the assembly time and reducing opportunities for disruptions related to reinforcement application, there is the potential for decreased OR time and thus cost savings.
Performance tests were performed ex-vivo (Implant Characteristics, Compatibility, and Tissue Manipulation) and in-vivo (Hemostasis, Tissue Healing, and Usability) and demonstrated that the Echelon Endopath Staple Line Reinforcement is substantially equivalent to predicate devices.
There was no assessment of clinical performance data to demonstrate substantial equivalence.
The conclusions of testing criteria and animal studies demonstrate that the Echelon Endopath Staple Line Reinforcement is as safe and effective and performs as well as predicate devices such as Gore Seamguard in terms of intended use, design, materials, biocompatibility, sterility, and performance. There is a smaller list of applicable anatomical sites when compared to predicate devices.
The Echelon Endopath Staple Line Reinforcement is indicated for use in surgical procedures where soft tissue transection or resection with staple line reinforcement is needed. The Echelon Endopath reinforcement can be used for buttressing of staple lines during lung resection and bariatric surgical procedures, as well as staple lines during gastric, small bowel and colorectal procedures.
There are no specific contraindications to using the Echelon Endopath Staple Line Reinforcement.