The ECHELON FLEX™ GST System - Controlling movement to help provide better outcomes

The ECHELON FLEXâ„¢ GST System

Controlling movement to help provide better outcomes

The ECHELON FLEX™ GST System

Controls tissue movement1 for a more targeted tissue transection with each firing2 Before firing

Pre-compression (15 seconds)— minimizes compression during final compression phase

During firing

Stabilizes tissue with Gripping Surface Technology3

Stabilizes movement at distal tip with powered firing4

1 Benchtop testing in porcine stomach tissue. Mean tissue movement from before clamping on tissue to release of tissue after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 1.5, 2.5, 3.3 and 4.0mm tissue thicknesses (1.5mm; GST60B 2.835mm vs EGIA60AMT 2.369mm NS; 2.5mm: GST60G 2.864mm vs EGIA60AMT 3.273mm p<0.001; 3.3mm: GST60T 0.897mm vs EGIA60AMT 6.814mm p<0.001; 4.0mm: GST60T 1.415mm vs EGIA60AXT 4.616mm p<0.001). PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, 2014, Data on File. (018986-140728) 2 Only reloads with Gripping Surface Technology have a proprietary ridged surface to provide an atraumatic grip on tissue to hold it in place during firing. Based on acute and long term evaluations in animate porcine stomach, bowel, lung and vasculature. Visual comparisons of 10-20 second clamp and release and full firing staple lines immediately following, 1hr after clamping, 14 days post op and at necropsy, as well as histological evaluation at 14 days post op, revealed no additional clinically relevant trauma to the tissues (018992-140728, 018992-151125, 018992-161026) 3 PRC048941D Completion Report for AMP Claims Testing for Stability and Motor Noise. May 2011. Ethicon data on file. (C922)

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1 GST System Blue and Green Reloads compared to Endo GIA with Tri Staple™ Technology Purple Reloads evaluated via gross observations of firings in 1.5mm to 3.0mm thick animate porcine ileum.

Average apposition ratings 2.81 (GST60B) and 2.56 (GST60G) vs 3.23 (EGIA60AMT), p=0.001. PSB004500 Compare compression damage and mucosal injury created during the firing of endoscopic stapling devices, 2016, Data on File (057886-160810) 2 Benchtop testing in porcine stomach tissue. Mean tissue movement from before clamping on tissue to release of tissue after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 1.5, 2.5, 3.3 and 4.0mm tissue thicknesses (1.5mm; GST60B 2.835mm vs EGIA60AMT 2.369mm NS; 2.5mm: GST60G 2.864mm vs EGIA60AMT 3.273mm p<0.001; 3.3mm: GST60T 0.897mm vs EGIA60AMT 6.814mm p<0.001; 4.0mm: GST60T 1.415mm vs EGIA60AXT 4.616mm p<0.001). PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, 2014, Data on File. (018986-140728) 3 Only reloads with Gripping Surface Technology have a proprietary ridged surface to provide an atraumatic grip on tissue to hold it in place during firing. Based on acute and long term evaluations in animate porcine stomach, bowel, lung and vasculature. Visual comparisons of 10-20 second clamp and release and full firing staple lines immediately following, 1hr after clamping, 14 days post op and at necropsy, as well as histological evaluation at 14 days post op, revealed no additional clinically relevant trauma to the tissues (018992-140728, 018992-151125, 018992-161026)

4 PRC048941D Completion Report for AMP Claims Testing for Stability and Motor Noise. May 2011. Data on File. (C922)

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Different approaches to device-to-tissue interaction

Tissue movement is influenced by manufacturer’s design principles ECHELON FLEX™ GST System1

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Endo GIA™ with Tri-Staple™ Technology

Control movement2

Promote movement3

• Multi-stage compression • Gripping Surface Technology • Closed channel

• Single-stage compression • Stepped cartridge face • Lagging staple deployment

System components include ECHELON FLEX™ Powered Plus Stapler and ENDOPATH ECHELON™ Reloads with Gripping Surface Technology.

GST System Blue and Green Reloads compared to Endo GIA with Tri Staple™ Technology Purple Reloads evaluated via gross observations of firings in 1.5mm to 3.0mm thick animate porcine ileum. Average apposition ratings 2.81 (GST60B) and 2.56 (GST60G) vs 3.23 (EGIA60AMT), p=0.001. PSB004500 - Compare compression damage and mucosal injury created during the firing of endoscopic stapling devices. August 2016. Ethicon data on file (057886-160810) Covidien Redefines Surgical Stapling with Introduction of New Tri-Staple. Available from https://www.youtube.com/watch?v=CXMvYBM0lcU [accessed 20 December 2016]

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New research: Movement creates unintended consequences

Tissue movement can result in incomplete capture of tissue layers in the staple line1 ECHELON FLEX™ GST System

Endo GIA™ with Tri-Staple™ Technology

Conceptual comparison demonstrating potential effects of tissue movement during firing. Results can vary based on tissue characteristics, device design, technique and other factors.

Please always refer to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.

Third-party trademarks used herein are trademarks of their respective owner.

1

PSB004500 - Compare compression damage and mucosal injury created during the firing of endoscopic stapling devices. August 2016. Ethicon data on file

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The ECHELON FLEX™ GST System

7 times more likely to fully capture mucosa in the staple line1

ECHELON FLEX™ GST System Blue and Green Reloads compared to Endo GIA™ with Tri Staple™ Technology Purple Reloads evaluated via gross observations of firings in 1.5mm to 3.0mm thick animate porcine ileum. PSB004500 Compare compression damage and mucosal injury created during the firing of endoscopic stapling devices, June 2016. Data on file (057885-160810, 057890-160810) 2 ECHELON FLEX™ GST System Blue and Green Reloads compared to Endo GIA™ with Tri Staple™ Technology Purple Reloads evaluated via gross observations of firings in 1.5mm to 3.0mm thick animate porcine ileum. Average apposition ratings 2.81 (GST60B) and 2.56 (GST60G) vs 3.23 (EGIA60AMT), p=0.001. PSB004500 Compare compression damage and mucosal injury created during the firing of endoscopic stapling devices. April 2016. Data on file (057886-160810).

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New research: Movement creates unintended consequences

The potential implications of tissue movement

Incomplete capture leads to an exposed mucosal edge with no protective mucus coating, making it more susceptible to bacterial invasion.

Certain bacteria can degrade collagen directly, as well as activate host cells that overproduce enzymes that break down collagen.

The increased breakdown of collagen upsets the progress of anastomotic healing which may lead to reduced tissue strength and increased incidence of leaks.

References Immune System Text, Ch 10: Parham, P. 2014. Preventing Infection at Mucosal Surfaces. The Immune System, Fourth Edition. (pp 267-294).

Shogan 2015 article: Shogan B, Belogorttseva N, Loung P, et al. Collagen degradation and MMP9 activation by Enterococcus faecalis contribute to intestinal anastomotic leak. Sci Transl Med. 2015. 7(286).

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Benchtop testingâ&#x20AC;&#x201D;relationship between mucosal capture and burst pressure

Better mucosal capture can improve leak resistance

Initial leak site is associated with areas of incomplete mucosal capture 78% of the time.1

ECHELON FLEX GST System staple lines exhibit a higher median burst pressure compared to TriStapleâ&#x201E;˘.2

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Benchtop testing of GST Green, GST Blue & Tri-Staple Purple in porcine ileum. Location of leak was associated with site of incomplete mucosal capture in 46 of 59 firings that had incomplete mucosal capture. PSB004560A Ex-vivo study of mucosal damage and first leak.

October 2016. Data on file (062244-161026)

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Benchtop testing in porcine ileum. Median leak onset pressure: Tri-Staple Purple (33.5mm Hg) vs GST Blue (46.7mm Hg) (p<0.001). Tri-Staple Purple (33.5mm Hg) vs GST Green (41.3mm Hg) (p=0.022). PSB004560A Ex-vivo study of mucosal damage and first leak. October 2016.

Data on file (062241-161026) 8

The ECHELON FLEX™ GST System

Controls tissue movement producing unsurpassed staple formation1,2,3,4 and better mucosal capture5

4x less tissue slippage6 during firing compared to Endo GIA™ Reloads with Tri-Staple™ Technology for unsurpassed staple performance1,2,3,4

7x more likely to fully capture mucosa in the staple line5

Exceptional staple line integrity across a range of tissue thicknesses with each reload7

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56% less tissue slippage during firing ECHELON Blue Reloads with GST compared to Covidien Endo GIA™ Purple Reloads with Tri-Staple™ Technology for unsurpassed stapling performance.

Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 1.5mm tissue thickness (GST60B 1.067mm vs EGIA60AMT 2.452mm p<0.001).

PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, July 2014, Data on File (018981-140728) 65% less tissue slippage during firing with ECHELON Green Reloads with GST compared to Covidien Endo GIA™ Purple Reloads with Tri-Staple™ Technology for unsurpassed stapling performance. Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 2.5mm tissue thickness (GST60G 1.148mm vs EGIA60AMT 3.261mm p<0.001). PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, July 2014, Data on File (018982140728) 87% less tissue slippage during firing with ECHELON Black Reloads with GST compared to Covidien Endo GIA™ Purple Reloads with Tri-Staple™ Technology for unsurpassed stapling performance. Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 3.3mm tissue thickness (GST60T 0.642mm vs EGIA60AMT 4.806mm p<0.001). PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, July 2014, Data on File (018983140728) 87% less tissue slippage during firing with ECHELON Black Reloads with GST compared to Covidien Endo GIA™ Black Reloads with Tri-Staple™ Technology for unsurpassed stapling performance. Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 4.0mm tissue thickness (GST60T 0.654mm vs EGIA60AXT 5.116mm p<0.001). PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, July 2014, Data on File (018983140728) GST System Blue and Green Reloads compared to Tri-Staple Purple Reloads evaluated via gross observations of firings in 1.5mm to 3.0mm thick animate porcine ileum. PSB004500 - Compare compression damage and mucosal injury created during the firing of endoscopic stapling devices. April 2016. Data on file. (057884-160810, 057890-160810) Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 1.5, 2.5, 3.3 and 4.0mm tissue thicknesses (1.5mm; GST60B 1.067mm vs EGIA60AMT 2.452mm p<0.001; 2.5mm: GST60G 1.148mm vs EGIA60AMT 3.261mm p<0.001; 3.3mm: GST60T 0.642mm vs EGIA60AMT 4.806mm p<0.001; 4.0mm: GST60T 0.654mm vs EGIA60AXT 5.116mm p<0.001). PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, July 2014, Data on File (018980-140728) Porcine tissue thickness measured at 8g/mm2 prior to firing. Tissue comfortably compressed to closed staple height per IFU. E0000000669 Design Intent and Verification Testing for Project RoadRunner to Support Tissue Range Claims, August 2014, Data on File, (020293-140820, 020293-161103)

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Appendix

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Surgeonsâ&#x20AC;&#x2122; needs change as procedures evolve and demands on instruments increase

Evolution of bariatric surgery

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25 years of leadership in MIP

Ethicon has evolved our portfolio to address changing surgical needs As MIP surgery has developed and patient challenges have increased, we continue to focus our product innovation on tissue-specific stapling that delivers superior outcomes.

Enabling minimally invasive approaches in thoracic, GYN, and general surgery

Delivering enhanced compression in bariatric and colorectal surgery

Delivering innovation to address evolving bariatric, colorectal, and thoracic procedures

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ECHELON FLEXâ&#x201E;˘ GST System design features

Mitigating effects of tissue slippage on staple formation Gripping Surface Technology utilizes proprietary pocket extensions to hold tissue in place as well as support and guide staple legs toward anvil pockets during firing

Re-designed bent staple tips with asymmetrical legs aims to mitigate remaining tissue slippage during firing

Closed channel gun provides a rigid foundation aiming to withstand high loads and stresses encountered in thick or dense tissue firings*

RESULT: Exceptional staple line integrity now across a range of tissue thicknesses with each reload1 * See Instruction for Use for tissue and reload specifications 1 Porcine tissue thickness measured at 8g/mm2 prior to firing. Tissue comfortably compressed to closed staple height per IFU. E0000000669 Design Intent and Verification Testing for Project RoadRunner to Support Tissue Range Claims, August 2014, Data on file , (020293-140820, 020293-161103)

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Providing alignment for the staple legs to hit the anvil pockets

Tissue slippage effect on staple formation ECHELON FLEXâ&#x201E;˘ GST System

Conventional stapler reloads

Tissue slippage

Model simulation of firing in challenging situations.

For illustrative purposes only.

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Unmet need in stapling:

Tissue slippage Thicker tissue creates unique challenges in stapling that surgeons address by modifying their approach to attain good stapling outcomes. One of these challenges is tissue slippage between the jaws of the device during firing.

Controlling movement delivers â&#x20AC;˘ Targeted tissue transections = greater precision1 â&#x20AC;˘ Less tissue slippage, may eliminate one reload per procedure2

Staple formation

Tissue milking

Endocutter on tissue

before firing

Endocutter on tissue after firing

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1

2

Benchtop testing in porcine stomach tissue. Mean tissue movement from before clamping on tissue to release of tissue after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 1.5, 2.5, 3.3 and 4.0mm tissue thicknesses (1.5mm; GST60B 2.835mm vs EGIA60AMT 2.369mm NS; 2.5mm: GST60G 2.864mm vs EGIA60AMT 3.273mm p<0.001; 3.3mm: GST60T 0.897mm vs EGIA60AMT 6.814mm p<0.001; 4.0mm: GST60T 1.415mm vs EGIA60AXT 4.616mm p<0.001). PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, July 2014, Data on File(C1725) Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 1.5, 2.5, 3.3 and 4.0mm tissue thicknesses (1.5mm; GST60B 1.067mm vs EGIA60AMT 2.452mm p<0.001; 2.5mm: GST60G 1.148mm vs EGIA60AMT 3.261mm p<0.001; 3.3mm: GST60T 0.642mm vs EGIA60AMT 4.806mm p<0.001; 4.0mm: GST60T 0.654mm vs EGIA60AXT 5.116mm p<0.001). PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, July 2014, Data on File (C1727)

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ECHELON FLEXâ&#x201E;˘ GST System increases performance in thick tissue

4x less tissue slippage1 for improved staple formation2,3,4,5

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Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 1.5, 2.5, 3.3 and 4.0mm tissue thicknesses (1.5mm; GST60B 1.067mm vs EGIA60AMT 2.452mm p<0.001; 2.5mm: GST60G 1.148mm vs EGIA60AMT 3.261mm p<0.001; 3.3mm: GST60T 0.642mm vs EGIA60AMT 4.806mm p<0.001; 4.0mm: GST60T 0.654mm vs EGIA60AXT 5.116mm p<0.001). PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, July 2014, Data on File (018980-140728) 56% less tissue slippage during firing ECHELON Blue Reloads with GST compared to Covidien Endo GIA™ Purple Reloads with Tri-Staple™ Technology for unsurpassed stapling performance.

Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 1.5mm tissue thickness (GST60B 1.067mm vs EGIA60AMT 2.452mm p<0.001).

PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, July 2014, Data on File (018981-140728) 65% less tissue slippage during firing with ECHELON Green Reloads with GST compared to Covidien Endo GIA™ Purple Reloads with Tri-Staple™ Technology for unsurpassed stapling performance. Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 2.5mm tissue thickness (GST60G 1.148mm vs EGIA60AMT 3.261mm p<0.001). PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, July 2014, Data on File (018982140728) 87% less tissue slippage during firing with ECHELON Black Reloads with GST compared to Covidien Endo GIA™ Purple Reloads with Tri-Staple™ Technology for unsurpassed stapling performance. Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 3.3mm tissue thickness (GST60T 0.642mm vs EGIA60AMT 4.806mm p<0.001). PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, July 2014, Data on File (018983140728) 87% less tissue slippage during firing with ECHELON Black Reloads with GST compared to Covidien Endo GIA™ Black Reloads with Tri-Staple™ Technology for unsurpassed stapling performance. Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 4.0mm tissue thickness (GST60T 0.654mm vs EGIA60AXT 5.116mm p<0.001). PRC067394 Tissue flow and functional performance of ENDOPATH ECHELON Reloads (GST) and Covidien’s reloads with TriStaple technology, July 2014, Data on File (

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Reliable staple formation across a range for each reload

Less tissue slippageâ&#x20AC;&#x201D;consistent staple formation

* Porcine tissue thickness measured at 8g/mm2 prior to firing. Tissue comfortably compressed to closed staple height per IFU. Ethicon, E0000000669 Design Intent and Verification Testing for Project RoadRunner to Support Tissue Range Claims, August 2014, Data on file (020293-140820, 020293-161103)

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Reliable staple formation across a range for each reload

Less tissue slippage—consistent staple formation

1 System components include ECHELON FLEX™ Powered Plus Stapler and ENDOPATH ECHELON™ Reloads with Gripping Surface Technology 2 Porcine tissue thickness measured at 8g/mm2 prior to firing. Tissue comfortably compressed to closed staple height per IFU. Ethicon, E0000000669 Design Intent and Verification Testing for Project RoadRunner to Support Tissue Range Claims, August 2014, Data on file. (020293-140820, 020293-161103) 3 GST – Porcine tissue thickness measured at 8g/mm2 prior to firing 4 EGIA – Intended tissue thickness range per manufacturer IFU

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Choosing the right reload for your procedure

Focus on closed staple height instead of color to choose the most effective reload for your patient situation

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ECHELON FLEXâ&#x201E;˘ GST System

System components and codes ECHELON FLEXâ&#x201E;˘ GST System Code

Description

Quantity per sales unit

PCEE60A

60mm Compact Articulating Endoscopic Linear Cutter,* 280mm

3

PSEE60A

60mm Standard Articulating Endoscopic Linear Cutter,* 340mm

3

PLEE60A

60mm Long Articulating Endoscopic Linear Cutter,* 440mm

3

*Instrument does not contain a reload.

Code

Color

Description

Open staple height

Closed staple height

Quantity per sales unit

GST60W

White

White reload intended for use in vascular/thin tissue

2.6mm

1.0mm

12

GST60B

Blue

Blue reload intended for use in regular tissue

3.6mm

1.5mm

12

GST60D

Gold

Gold reload intended for use in regular/thick tissue

3.8mm

1.8mm

12

GST60G

Green

Green reload intended for use in thick tissue

4.1mm

2.0mm

12

GST60T

Black

Black reload intended for use in very thick tissue

4.2mm

2.3mm

12

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Please always refer to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.

The third-party trademarks used herein are trademarks of their respective owners.

Ethicon Endo-Surgery (Europe) GmbH HummelsbĂźtteler Steindamm 71 22851 Norderstedt, Germany www.ethicon.com

Š Ethicon Endo-Surgery (Europe) GmbH 2017, 066580-170203 EMEA 24