Staple line reinforcement or buttressing is a popular surgical technique used to increase staple line strength and to help prevent internal bleeding during and after surgery. ECHELON ENDOPATH™ Staple Line Reinforcement (SLR) is a novel buttressing device that provides sterile, bioabsorbable staple line reinforcement to reduce potential complications in bariatric, thoracic and general surgeries. Used with ECHELON FLEX™ Powered Staplers with GST reloads, this first buttress solution from Ethicon improves ease of use, performance, functionality and OR efficiency over existing buttressing options.

· Click-and-go applicator provides clamp-and-release buttress loading with accurate, pre-applied, self-adhesive material for consistent application1 and increased OR efficiency.2 Surgeons can place anvil or cartridge stapler jaws on top or bottom of the applicator for faster buttress application in only 4 steps and 18 seconds,2 in 1/3 the time as competing buttressing solutions.

· Proprietary buttress attachment material (BAM) affixes a specially patterned buttress across the entire anvil and cartridge stapler face for precise control with no slipping, twisting, sliding or bunching when manipulating on tissue.1 The material also gently releases from the device as to not compromise tissue that has been transected during surgery.3

· Made from materials trusted in VICRYL® and PDS® sutures, water-soluble copolymers achieve the same hemostasis (prevention of bleeding) as competitors with 45% less foreign material left behind for patients to absorb.4,5

1. Based on coverage after manipulation assessment on porcine tissue. 2. Ethicon ECHELON ENDOPATH™ Staple Line Reinforcement. Value Analysis Summary. 2020. pg. 5. Publication 133989-200304. 3. Ethicon ECHELON ENDOPATH™ Staple Line Reinforcement. Value Analysis Summary. 2020. pg. 6. Publication 133989-200304. 4. ECHELON ENDOPATH™ Staple Line Reinforcement vs. GORE® SEAMGUARD® Staple Line Reinforcement. Hemostasis: evaluated via gross observations of firings requiring intervention in 1.38mm to 2.32mm thick porcine ileum and jejunum tissues, evaluated via a 5-point Likert scale resulting in statistically no difference in Likert scores. Material: based on average total surface area measurements (26.79cm2 vs. 49.21cm2). 5. In a tissue test ECHELON ENDOPATH™ Reinforcement covered all staple legs in (40/40) applications compared to GORE™ SEAMGUARD™ (11/40), p<0.05.

Staple line reinforcement, or buttressing, is a popular technique used to increase staple line strength and potentially reduce internal bleeding and air leaks during and after thoracic, bariatric or general surgeries. ECHELON ENDOPATH™ Staple Line Reinforcement (SLR) is a unique buttressing device that is used with market-leading ECHELON FLEX™ Powered Staplers to provide sterile, bioabsorbable staple line reinforcement.

The design and development process

The ECHELON ENDOPATH™ Staple Line Reinforcement (SLR) is Ethicon's first buttressing solution. Ethicon recognized the need to add a solution that could strengthen the ECHELON brand, a recognized leader in surgical stapling solutions, and eliminate the need for users to turn to another brand for the buttressing portion of their surgical needs. ECHELON ENDOPATH™ SLR offers significant improvements over existing buttressing options, which can require special attention to attach, do not consistently cover all staples and may break loose with typical maneuvering during stapling procedures.6

The design team addressed numerous challenges to create the ECHELON ENDOPATH™ SLR. This buttressing solution represents many significant "firsts."

· The team needed to create a buttressing material that attached securely through application and tissue manipulation, but released gently when needed. To address these conflicting requirements, the design team, located in Ohio; New Jersey; and Norderstedt, Germany, spent 5 years concurrently developing both a buttress material and proprietary buttressing attachment material (BAM). The BAM reacts to humidity and moisture, passing from the surgical site within an hour and flushing from the patient's body within 48 hours.

· Research showed the design needed to deliver superior strength at the staple line. To address this, the team developed a specially designed knit architecture within the buttressing to deliver superior strength at the staple line during the first 14 days of tissue healing.7

· The team also wanted to design a solution that would not lead to patient inflammation during healing. To do this, the team sterilized the buttressing material using a novel, tightly dosed E-beam sterilization process that provides uncompromised performance without causing irritation during healing. The buttress material is also 16% thinner than competitors (on average),8 leaves behind 45% less foreign absorbable material4,5 and absorbs faster than other absorbable buttress options.9

· The team also needed a solution that attached the buttress and BAM onto the stapler face with consistency. To meet this need, the team developed an innovative click-and-go applicator that eliminates the need for suture lacings or tubes of adhesives. This SLR applicator covers all staples with the buttress in 100% of applications.10 For increased efficiency, this SLR requires only 4 steps to load.2

· Because OR staff members are often working under time pressure in the OR to avoid procedure delays, the team needed the intended use of this device to be intuitive within the design. All design attributes were extensively tested through several rounds of formative and summative testing worldwide.

· Finally, the team needed to protect the buttress and BAM in a variety of environments, including during transport and in storage on a hospital shelf for up to 3 years. To address this, the team had to design special packaging. Because this product could not be transported using global temperature-controlled shipping lanes, the team designed thick, deep foil nitrogen-filled packaging to protect the product. Team members also designed a temperature tracking indicator on the exterior of the packaging to help ensure the integrity of the product both during transit and while in possibly lengthy storage.

The solution

ECHELON ENDOPATH™ Staple Line Reinforcement (SLR) improves ease of use, performance, functionality and OR efficiency with consistent, quicker loading; precise control; and more secure attachment for uninterrupted tissue manipulation from start to finish.1

· Easy, consistent buttress loading with a novel click-and-go applicator. This applicator provides easy clamp-and-release buttress loading with pre-applied, self-adhesive material for consistent application1 and increased OR efficiency.2

- There's no dedicated anvil or cartridge side for faster application in the OR.

- This SLR applicator covers all staples with the buttress in 100% of applications versus competitors that cover 28% or fewer staples.10

- Specific features within the applicator securely hold the buttressing material, protect the buttress adhesive (BAM) from premature contact and immediately communicate the correct orientation for buttress application.

- Special guiding ridges help ensure proper positioning of the stapler jaws for consistent and accurate buttress placement.

- The click-and-go applicator is designed with no dedicated up or down orientation so the buttress applies evenly on the stapler jaws whether the anvil or cartridge side clamps on the top or bottom of the device.

· Seamless performance and exceptional coverage after tissue manipulation: With this device's proprietary buttress attachment material (BAM), the buttressing stays in place on the stapler with no slipping, twisting, sliding or bunching1 when manipulating tissue. It also gently releases from tissue when needed, so surgeons can transect as desired.

· Designed for OR efficiency: This SLR requires fewer steps and less time to load than competitors.2 This SLR requires only 4 steps to load in 18 seconds2 rather than the competitor's 12-16 steps in 78-81 seconds. In addition, 100% of nurses surveyed agree ECHELON ENDOPATH™ SLR is more efficient to load than competitors.11

· This SLR is designed for use with ECHELON FLEX™ Powered Staplers with GST reloads, which are associated with a lower rate of air leaks and bleeding complications than other surgical stapling systems.12,13

Positive impact on healthcare

Studies estimate that at least 70% of US bariatric surgeons use staple line reinforcement (SLR), or buttresses, in sleeve procedures and 48% use this SLR in bypass procedures. Current buttresses require larger port access in patients and special attention in attaching to the stapler. They may also loosen during typical maneuvering in procedures.6

Advances in application and uninterrupted buttressing, such as those offered by the ECHELON ENDOPATH™ SLR may increase OR efficiency.

· 30% of general laparoscopic cases have at least one device-related interruption.14

· 32% of admission costs can be attributed to OR time in laparoscopic bariatric surgery.15

· Distractions increase the chance of adverse patient outcomes in perioperative settings, according to AORN.16

· Loading in less time may lower OR costs. Studies demonstrate an estimated $197 in OR time-savings compared to competition in typical sleeve gastrectomy.17

With its intuitive design and ease of use, the ECHELON ENDOPATH™ SLR has also reduced the need for additional hospital staff training in what is typically a very high turnover position. This device may also help to reduce the potential for errors in device preparation prior to patient use.

Better healing experience for the OR staff and patient

ECHELON ENDOPATH™ SLR may help provide a better healing experience for the patient. Studies show buttresses may improve outcomes in key surgeries. This device offers the strongest buttress in the market and helps ensure full coverage of staples for the first 14 days of critical healing.7

The device is also shown to increase OR efficiency, which may lead to shorter time under anesthesia for the patient. In addition, this buttressing solution may offer surgeons greater stability on the tissue,3 again benefitting patients.

Surgeons have responded enthusiastically to the ECHELON ENDOPATH™ SLR with comments including:

"The genius of [this] buttressing is in making it a knit-based product… it doesn't add a lot of thickness… but adds strength by becoming part of the tissue."

"… clearly covers 100% of staples…"

"It's a game changer..."

"I'm shocked how easy this is to use!"

"It is much easier to use… Good hemostasis too."

Responsible design choices

· 97% of surveyed nurses agreed ECHELON ENDOPATH™ SLR wastes less buttress material.11

· In addition, the design and engineering team carefully considered manufacturing requirements during design. Top and bottom shrouds on the applicator are identical, as are several internal components, in order to minimize injection molding tooling and waste.

Ongoing benefits to the client

· This first-of-its-kind buttress solution has infused new innovation into Ethicon's stapler portfolio, demonstrating a commitment to both surgeon and patient while offering the most complete, advanced stapling portfolio to help surgeons optimize outcomes.

· This addition contributes to the strength of the ECHELON brand—a recognized leader in surgical stapling solutions—and should help drive portfolio growth.

· Several proprietary or novel solutions developed for SLR, including shipping and package indicators as well as proprietary design formulas, will have application in other parts of the client's business:

· The joint global effort in developing this device across multi-national client locations has strengthened teamwork for both Ethicon and the brand, paving the way for continued innovative solutions in the future.

See footnotes supporting claims in this response in the image section.