Intended for healthcare professionals

Surgical stapling

Surgical complications and readmissions remain a critical burden in surgery. For over 30 years, we're studied tissue in the most complex conditions to design the most advanced technology available - offering you a staple line you can rely on.

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Surgical stapling
Surgical stapling
Surgical stapling
Surgical stapling
Surgical stapling
Surgical stapling

Evidence

Surgical stapling

Economic evidence

Preventing just one surgical complication can lower costs for your system.


  • Bariatric bleed - $7,000 in cost savings1
  • Thoracic bleed - $9,500 in cost savings1
  • Thoracic air leak - $6,500 in cost savings2
  • Colorectal leak - $12,000 in cost savings1
Surgical stapling

Clinical evidence

The use of Johnson & Johnson MedTech Surgical Stapling devices has demonstrated an association with improved clinical outcomes—across varied tissue types, patient populations and countries—in bariatric and thoracic procedures.


  • Reduced bleeding, strictures and leaks in gastric resections3
  • 73% reduced hemostasis-related complications in laparoscopic sleeve gastrectomy4
  • Reduced intra-operative air leaks in thoracoscopic lobectomy5
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Better outcomes, lower costs

$11,410

Estimated savings per 100 casesA based on reduction in hemostasis-related complications with ECHELON™ Powered Staplers1,4

$89,300

Estimated savings per 100 casesA based on reduction in bleeding-related complications with ECHELON FLEX™ Powered Vascular Stapler1,6

$61,200

Estimated savings per 100 casesA based on reduction in anastomotic leaks with ECHELON CIRCULAR™ Powered Stapler1,7

3D stapling and gripping surface technology
3D stapling and gripping surface technology

3D stapling and gripping surface technology

Our most advanced technologies to date are designed and tested for optimal staple line security - during and after a procedure. With enhanced Gripping Surface Technology, tissue is stabilized throughout the jaws of the device, while offset closure of our 3D staple design evenly distributes compression throughout the staple line and reduced potential leakage pathways compared to traditional 2D staples.8B  ETHICON™ 3D Reloads provide exceptional staple line integrity.9,10C

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Fewer complications, better outcomes

We commit 100,000+ hours to research and development, performing 200+ rigorous tests and 850,000+ hours of quality inspections on every stapler we design before it is released. So you can feel confident in your staple line.

Ethicon 4000 Stapler
Ethicon 4000 Stapler

Our most secure staple line yet9D

ETHICON™ 4000 Stapler

Our latest innovation in laparoscopic stapling, the ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are designed to manage tissue complexities for the most secure staple line yet.9D Featuring 3D Technology and enhanced Gripping Surface Technology, it more evenly distributes pressure for reduced leaks and bleeds.8E

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Improved leak resistance with 23% fewer staple line interventions due to bleeding11F

Delivered more consistent staples, from the first staple to the last9,12G

Exceptional staple line integrity across the broadest range of tissue thickness9,10C

Echelon Endopath SLR
Echelon Endopath SLR

Superior clinical performance

ECHELON ENDOPATH™ Staple Line Reinforcement

ECHELON ENDOPATH Staple Line Reinforcement is the first and only buttress designed specifically for use with ETHICON™ and ECHELON™ Staplers. It can be used with any 60mm ETHICON™ 3D or ECHELON™ Gripping Surface Technology (GST) Reloads and is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. It can also be used with Intuitive SureForm™ 60mm blue, green and black reloads.28

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In a multi-center clinical study of thoracic procedures, no prolonged air leaks or empyema occurred related to SLR.13

In an independent clinical study of lobectomy procedures, usage of SLR was associated with significantly lower incidence of intraoperative air leakage at the staple line and significantly shorter time of indwelling chest drainage and length of hospital stay compared to conventional staplers.5

In a multi-center clinical study on bariatric procedures, no bleeding, leaks or strictures were associated with the use of SLR.3

ECHELON LINEAR™ Cutter
ECHELON LINEAR™ Cutter

Fewer leaks. Greater control.14,15H

ECHELON LINEAR™ Cutter

The ECHELON LINEAR™ Cutter features Gripping Surface Technology (GST), 3D Stapling Technology and re-engineered jaws. Narrow jaws and a four-row staple pattern are designed for easier insertion into tissue, less force to fire the stapler16I and less staple height variation even in thick tissue.16J

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ECHELON LINEAR Cutter delivered 47% fewer leaks at the staple line compared to PROXIMATE™ Linear Cutter.14,15H

GST and 3D Stapling Technology work together to help surgeons support patient outcomes17K

3D Stapling Technology more evenly distributes compression throughout the staple lineL and reduced potential leak pathways.18M

ECHELON FLEX™ Powered Vascular Stapler

Optimized for vessel transections

ECHELON FLEX™ Powered Vascular Stapler

Designed specifically for enhanced performance vessel transection, the ECHELON FLEX™ Powered Vascular Stapler is optimized to navigate in tight and challenging spaces with a narrower anvil19N, thinner shaft,19,20O and greater articulation19P than Endo GIA™ Curved Tip Reload with Tri-Staple™ Technology.


  • 66% reduction in bleeding complications compared to Medtronic non-powered staplers,6Q 56% reduction in intra-op blood loss compared to non-powered staplers21R

  • 12% reduction in hospital costs,21S 14% reduction in length of stay,6T 28% shorter OR time in VATS Lobectomy procedures.21U

  • 26% narrower curved, blunt tip anvil, providing enhanced maneuverability around vascular structures than Endo GIA™ Curved Tip Reload with Tri-Staple™ Technology.19N

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Reduced leaks22,23V with optimized perfusion23V

ECHELON CIRCULAR™ Powered Stapler

Designed for anastomosis creation in colorectal, bariatric, and thoracic procedures, the ECHELON CIRCULAR™ Powered Stapler provided 61% fewer leaks at the staple line without compromising perfusion compared to Medtronic DST Series™ EEA™ Stapler.22,23W It combines 3D Stapling and GST on a powered platform and is backed by large-scale real world evidence.7X


  • 85% reduction in anastomotic leaks compared to manual circular staplers24Y
  • Associated with a 50% reduction in anastomotic leak rateZ and 88% reduction in anastomotic bleeding rateAA as compared vs. manual circular staplers25
  • Associated with $53,987 annual hospital cost savings (per 100 cases related to anastomotic leaks) vs manual circular staplers26BB
  • Delivered 1.8%24CC and 1.7% anastomotic leak rates27DD in two clinical studies compared to manual circular staplers
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Supporting documentation

PDF

The science of stapling: 3D staple form

PDF

ETHICON™ 4000 with ETHICON™ 3D Reloads fact sheet

PDF

ECHELON CIRCULAR™ Powered Stapler product brochure
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References

A. Number of cases is for illustrative purposes. Complication rates are based on published evidence, and cost savings is based on Ethicon market research on complication cost.


B. Evaluation of leakage pathways. ETHICON™ 3D Reload (ER60B) had less leak pathway area at 0.302 in2 compared to ECHELON ENDOPATH™ GST Reload (GST60B) at 0.401 in2.


C. Exceptional staple line integrity based on staple form quality assessment for ETHICON™ 3D Reloads (ER60W/B/G/T). Tissue thickness range comparison: ETHICON™ 3D reloads (maximum 4.0mm) versus Tri-Staple™ reloads (maximum 3.0mm).


D. Staple line security was evaluated for the following staplers by assessing the consistency of staple formation and height: the ETHICON™ 4000 Stapler with ETHICON™ 3D Reloads, the ECHELON™ 3000 Stapler with GST Reloads, Medtronic Staplers with Tri-Staple™ Reloads, and the Intuitive SureForm™ Stapler.


E. Finite element analysis found a 37% increase in staple line area for ETHICON™ 3D Reloads compared to ECHELON ENDOPATH™ Reloads with GST. Evaluation of leakage pathways found ETHICON™ 3D Reload (ER60B) had less leak pathway area at 0.302 in2 compared to ECHELON ENDOPATH™ GST Reload (GST60B) at 0.401 in2.


F. Based on retrospective comparative analysis of hemostasis performance in a porcine model comparing the proportion of transections requiring intervention for the ETHICON 4000 Stapler with 3D Reloads (EC3D60C & ER60W) vs. the ECHELON™ 3000 with GST Reloads (ECH60C & GST60W), n=114.


G. Consistency is defined as reduced staple height variation along the staple line. This is measured by the range of average delta from nominal staple height within the functional zone (in mm): ETHICON™ 3D Reloads (0.0128 - 0.0242); Tri-Staple™ Reloads (0.0403 - 0.0720).


H. Benchtop testing on porcine colon measuring staple line leak rate at 30mmHg, 52.8% for Medtronic GIA™ with TriStaple™ Technology, 52.8% for ETHICON™ Linear Cutter [NTLC], and 52.8% for PROXIMATE™ Linear Cutter [TLC] to 27.7% for ECHELON LINEAR™ Cutter (n=36, p<0.001). Greater control supported by a surgeon usability evaluation = 65% agreed, n=37.


I. Benchtop testing on porcine colon measuring force to fire on 1.5mm colon with blue reload, comparing the 4-row, ECHELON LINEAR™ Cutter to the 6-row, ETHICON™ Linear Cutter (NTLC) (n=32, p<0.001).


J. Benchtop testing comparing to ETHICON™ Linear Cutter [NTLC], PROXIMATE™ Linear Cutter [TLC], and Medtronic GIA™ with DST™ Technology, averaged across on a range of tissue thickness (1.5-3.3mm), n=32 per device per tissue thickness, p<0.001.


K. 3D staple design and Gripping Surface technology (GST) is designed to reduce surgical risk factors.


L. Staple line compression analysis on Ethylene-Vinyl Acetate (EVA) foam assessing the deformation of foam. ECHELON LINEAR™ Cutter had better distributed compression pressure at 7.20% average pressure variation compared to PROXIMATE™ Linear Cutter [TLC] at 7.44% (P=.012), Medtronic GIA™ with DST™ Technology at 10.93% (P<.001), (N=32000)


M. Staple line assessment of compression zones inside of the staple line, comparing lower pressure outliers rates of 0.6% for ECHELON LINEAR™ Cutter (N= 30320) to [1.3% for PROXIMATE™ Linear Cutter [TLC] (N=30314) and 0.8% for Medtronic GIA™ with DST™ Technology (N=31980) (P<0.001).


N. Comparison of anvil widths for ECHELON FLEX™ Powered Vascular Stapler (PVE35A) vs. Endo GIA™ Curved Tip Reload with Tri-Staple™ Technology (EGIA30CTAVM). Measurement results: 7.0mm vs. 9.5mm respectively.


O. Approach angles assessed in a virtual CAD environment in the 5th intercostal space.


P. Based on articulation data from IFUs of each device.


Q. Review of 1,051 cases between 2015 and 2016 from the Premier Healthcare Database (4.8% vs 14.2%; p=0.010).


R. Review of 275 cases between 2008 and 2016 from Yonsei University College of Medicine, Seoul, Korea (182.4 vs. 79.8; p=0.0004).


S. Review of 275 cases between 2008 and 2016 from Yonsei University College of Medicine, Seoul, Korea ($12,281 vs. $10,822; p<0.0001).


T. Review of 1,051 cases between 2015 and 2016 from the Premier Healthcare Database. Length of stay: 4.99 vs 5.82; p=0.047.


U. Review of 275 cases between 2008 and 2016 from Yonsei University College of Medicine, Seoul, Korea (189.9 min vs 137.1 min, p < 0.0001).


V. Preclinical perfusion model comparing Ethicon CDH29P to Medtronic Covidien EEA2835, in which perfusion was not statistically significantly different between devices (p>0.05).


W. Benchtop testing in porcine tissue ≤30mmHg (26mmHg average pressure experienced during intra-operative leak test), comparing Ethicon CDH29P to Medtronic (Covidien) EEA2835 (p<0.001) and preclinical perfusion model, in which perfusion was not significantly different between devices.


X. A retrospective matched analysis of 165 Echelon Circular cases from clinical study, and 1,348 manual circular stapler cases from Premier Healthcare Database [ECHELON CIRCULAR 1.8% (3/165) vs. manual circular 6.9% (93/1348) for anastomotic leaks, p<0.001; ECHELON CIRCULAR 6.1% (10/165) vs. manual circular 10.8% (146/1348) for re-admissions, p=0.019].


Y. Impact of the Novel Powered Circular Stapler on Risk of Anastomotic Leakage in Colorectal Anastomosis. A Propensity Score-Matched Study. [ECHELON CIRCULAR 1.7% (1/60) vs. manual circular 11.8% (14/119), p=0.022].


Z. Based on a meta-analysis of 2497 subjects with an anastomotic leak rate of 4.1% for Powered Circular stapler and 8.23% for Manual Circular Stapler (p<0.001).


AA. Based on a meta-analysis of 2497 subjects with an bleeding rate of 0.96% for Powered Circular stapler and 7.91% for Manual Circular Stapler (p<0.001).


BB. Budget Impact Model for the ECHELON CIRCULAR Powered Stapler (N=100) versus manual circular staplers (N=100) in colectomies with left-sided anastomosis.


CC. A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses. While this study was not statistically powered to determine anastomotic leak rate, 3 of the 168 patients experienced an anastomotic leak at the circular staple line and 1 patient leak was not related to the anastomosis. Thirty-five of the 168 patients had a diverting ostomy.


DD. Impact of the Novel Powered Circular Stapler on Risk of Anastomotic Leakage in Colorectal Anastomosis. A Propensity Score-Matched Study. [ECHELON CIRCULAR 1.7% (1/60) vs. manual circular 11.8% (14/119), p=0.022].


  1. Ethicon. Specialty Health Economic Market Access: Focus on Complication Outcomes to Improve Patient Care. 2018.
  2. Yoo A, et al. Burden of air leak complications in thoracic surgery estimated using a national hospital billing database. ClinicoEconomics Outcomes Res. 2017;9:373-383.
  3. Andrew Wheeler, Jon Schram, Keith Gersin and Dmitri Stefanidis, et al. Safety and Usability of the ECHELON ENDOPATH™ Staple Line Reinforcement in Gastric Resections. J Surg 19 (2023): 85. 
  4. Rawlins L, Johnson BH, Johnston SS, et al. Comparative Effectiveness Assessment of Two Powered Surgical Stapling Platforms in Laparoscopic Sleeve Gastrectomy: A Retrospective Matched Study. Medical Devices: Evidence and Research. 2020:13 195–204. doi: https://doi.org/10.2147/MDER.S256237.   
  5. Mitsui, S., Tanaka, Y., Nishikubo, M., et al. Safety and efficacy of new staple-line reinforcement in lung resection: a prospective study of 48 patients. Surg Today 54, 779–786 (2024). https://doi.org/10.1007/s00595-024-02798-x.
  6. Miller DL, et al. Impact of powered and tissue-specific endoscopic stapling technology on clinical and economic outcomes of video-assisted thoracic surgery lobectomy procedures: a retrospective, observational study. Advances in Therapy. 2018; 35:707-723.
  7. Sylla P, Sagar P, Johnston S, et al. Outcomes associated with the use of a new powered circular stapler for left-sided colorectal reconstructions: a propensity score matching-adjusted indirect comparison with manual circular staplers. Surgical Endoscopy. 2021. In print.   
  8. Johnson & Johnson and its affiliates. Evaluation of Leak Pathways for Claims: Echelon 4000 with 3D Reloads vs Echelon 3000 Stapler with GST. November 2024. Windchill # 502123426.
  9. Johnson & Johnson and its affiliates. Ethicon™ 4000 with Ethicon™ 3D Reloads – Staple Performance Claims. February, 2024. Windchill # 502188145
  10. Medtronic Tri-Staple™ Reload. Intended Tissue Thickness Range. Document #P100153.
  11. ETHICON. Project Royal Retrospective Analysis: Hemostasis Performance Evaluation of Royal Stapler with Royal 3D 60 mm White Reload Compared to the ECHELON™ 3000 Stapler with 2D Gripping Surface Technology 60 mm White Reload in Non-Survival Swine Gastroepiploic Models.  1/23/2025. Windchill #PRE 24-0058.
  12. Global Business Insights. JJMT Market & Share 4Q'24 WW Surgery. March, 2025.
  13. Kesler KA, Zeltsman D, Martin LW, et al. Safety and usability of an endo staple line reinforcement device for pulmonary resections. J Thorac Dis. 2023;15(11):6151-6159.
  14. Ethicon, Cornerstone Staple Line Leak Claims Testing. 1.19.2023. Windchill Document #500897557.
  15. Ethicon, Echelon Linear Cutter (Cornerstone) Customer Usability Claim Summary Report. 11.10.2022. Windchill Document #501027381.
  16. Ethicon, Cornerstone Stapling Performance Claim Test Completion Report. 1.30.2023. Windchill Document #500927926.
  17. Ethicon, Cornerstone Design Plan. 11.14.2023. Windchill Document #DC002975.
  18. Ethicon, Cornerstone More Evenly Distributed Pressure Claim Completion Report. 9.27.2023. Windchill Document #500916693.
  19. Ethicon, ECHELON FLEXTM Powered Vascular Stapler Commercial Claim Sub-Completion Report 1. 11.19.2014. Windchill Document #PRC068229.
  20. Ethicon, ECHELON FLEX Powered Vascular Stapler Commercial Claims Sub-Protocol 1. 10.17.2014. Windchill Document #PRC068228.
  21. Park et al, Clinical and economic benefits associated with the use of powered and tissue-specific endoscopic staplers among the patients undergoing thoracoscopic lobectomy for lung cancer. Journal of Medical Economics. 2019;4: 1-8.
  22. Ethicon, Leak Claims Testing. 11.29.2016. Windchill Document #PRC077848.
  23. Ethicon, COMPARISON OF STAPLE LINE PERFUSION BETWEEN 29MM ECHELON CIRCULAR POWERED STAPLER (CDH29P) AND 28MM DST SERIES EEA CIRCULAR STAPLER (EEA2835). 1.11.2017. Windchill Document #PSB004557.
  24. Pla-Marti V, Martin-Arevalo J, Moro-Valdezate D, et al. Impact of the novel powered circular stapler on risk of anastomotic leakage in colorectal anastomosis: a propensity score‑matched study. Techniques in Coloproctology.2020; 25:279-284.
  25. Martín-Arévalo J, Pla-Martí V, Huntley D, et al. Two-row, three-row or powered circular stapler, which to choose when performing colorectal anastomosis? A systematic review and meta-analysis. Int J Colorectal Dis. 2024;39:51.
  26. Pollack E, Johnston S, Petraiuolo WJ, Roy S, Galvin T. Economic analysis of leak complications in anastomoses performed with powered versus manual circular staplers in left-sided colorectal resections: A US-based cost-analysis. ClinicoEconomics and Outcomes Research. 2021;13:531-540.
  27. Herzig D, Ogilvie J, Chudzinski A, et al. Assesment of a circular powered stapler for creation of anastomosis in left-sided colorectal surgery: A prospective cohort study. International Journal of Surgery. 2020; 84: 140-146.
  28. ECHELON ENDOPATH™ Staple Line Reinforcement Instructions for Use. Johnson and Johnson MedTech.

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For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

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