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ECHELON+ Stapler
ECHELON+ Stapler
The ECHELON+Stapler with GST Reloads advances staple line security to deliver fewer leakage pathways at the staple line, even in challenging conditions.1*
The Dynamic Firing in the ECHELON+ Stapler with GST Reloads slows as it engages thick tissue to optimize compression and audible feedback.2†
ECHELON+ Anvil is designed for consistent compression and to optimally capture and form staples.3 It features wide tapered anvil pockets for optimal capture area3, and atraumatic tapered tip designed to achieve gentle tissue handling and optimized otomy entry.3‡
IMAGES
Advanced staple line security, even in challenging conditions1*
Less malformed staples4§
ECHELON+ Anvil is designed for consistent compression and to optimally capture tissue and form staples.3
Fewer leakage pathways at the staple line5¶
ECHELON+ Stapler delivered fewer leakage pathways at the staple line across a range of physiologic to supraphysiologic pressures5¶ and demonstrated better staple formation in thick tissue compared to Medtronic Staplers with Tri-Staple™ Reloads. 4§
More uniform compression.6β Less tissue slippage7€
The ECHELON+ Stapler with GST Reloads demonstrated 32% more uniform staple line compression6β and delivered 4x less slippage compared to Medtronic Signia with Tri-Staple™ Reloads.8\\
Echelon Plus Stapler Body of Evidence
Since 2017, the use of ECHELON Powered Staplers has demonstrated an association with improved hemostasis-related and economic outcomes¥ – across tissue types, patient populations, and countries—in large-scale, peer-reviewed studies.9-13
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References
* Advancing staple line security with fewer leakage pathways and less malformed staples. Fewer leakage pathways: benchtop testing in porcine tissue ≤ 30mmHg (26mmHG average pressure experienced during typical leak test), comparing Ethicon ECHELON+ Stapler PSEE60A with GST Reloads GST60B to Medtronic Signia™ and Endo GIA™ Staplers with Tri-Staple™ Reloads EGIA60AMT. Cumulative number of leaked tests (0/30), (7/30) & (9/30) respectively, n=30, p < 0.05. Fewer malformed staples: benchtop testing in 3.3mm and 4.0mm porcine tissue comparing malformed staples between ECHELON+ Stapler with GST Reloads (GST60B, GST60T) to Medtronic Signia™ Stapler with Tri-Staple™ Reloads (EGIA60AMT, EGIA60AXT) and Endo GIA™ with Tri-Staple™ Reloads (EGIA60AMT, EGIA60AXT). Percentage malformed results: 1.14% vs 4.28%, p < 0.05
† Dynamic Firing refines the performance of the ECHELON+ Stapler to reduce variation within design specifications. The average transection time difference between 1.0mm and 4.0mm porcine tissue was 4.889 vs 2.992, p-value <0.05
‡The design of the ECHELON+ Stapler is refined with an updated anvil to reduce variation within design specifications.
§ Benchtop testing in 3.3mm and 4.0mm porcine tissue comparing malformed staples between ECHELON+ Stapler with GST Reloads (GST60B, GST60T) to Medtronic Signia™ Stapler with Tri-Staple™ Reloads (EGIA60AMT, SIG60AXT) and Endo GIA™ with Tri-Staple™ Reloads (EGIA60AMT, EGIA60AXT). Percentage malformed results: 1.14% vs 4.28%, p < 0.05
¶ Benchtop testing in porcine tissue ≤ 30mmHg, ≤ 40mmHg, ≤ 50mmHg (26mmHG average pressure experienced during intra-operative leak test), comparing Ethicon ECHELON+ Stapler PSEE60A with GST Reloads GST60B to Medtronic Signia™ and Endo GIA™ Staplers with Tri-Staple™ Reloads EGIA60AMT. Leak results at ≤ 30mmHg, ≤ 40mmHg, ≤ 50mmHg respectively, (0/30, 7/30, 14/30), (7/30, 13/30, 23/30), (9/30, 21/30, 22/30), p < 0.05.
β Benchtop testing in 3.2mm synthetic tissue comparing staple line compression between ECHELON+ Stapler with GST Reloads (PSEE60A, GST60B, GST60G) to Medtronic Signia™ and Endo GIA™ Staplers with Tri-Staple™ Reloads (EGIA60AMT). Resulting in a statistically significant compression uniformity, p<0.05.
€ In benchtop testing in porcine tissue, the ECHELON™ GST System (PSEE60A, GST60G) had less mean longitudinal change in 3.3mm thick tissue, 0.94 vs. 3.65, compared to the Signia™ Stapling System (SIGPHANDLE, EGIA60AMT), p-value <0.05. Based on unchanged design input specifications between ECHELON FLEX™ GST System and ECHELON+ Stapler with GST Reloads, no significant difference in performance is expected.
\\ In benchtop testing in porcine stomach tissue, the ECHELON+ Stapler with GST Reloads (PSEE60A, GST60T) had less mean longitudinal change in 4.0mm thick tissue, 0.79mm vs. 4.09mm, compared to the Signia™ Stapling System (SIGPHANDLE, SIG60AXT), p-value <0.05.
¥ Compared with manual and/or competitive powered staplers
1. Ethicon, PRC096436A Ex-Vivo Comparison of Staple Line Leak Pressure: Echelon Flex Powered Plus Stapler with GST vs Endo GIA and Signia with Tri-Staple Technology, Aug 2020, Data on file. Ethicon, PRC096858A Evaluation of Malformed Staples in Thick Tissue for Claims: Echelon Flex Powered Plus Stapler with GST vs Endo GIA and Signia with TriStaple Technology, Aug 2020, Data on file (159504-201117 EMEA)
2. Ethicon, 08122020 Design Intent for ECHELON+ Firing Memo (Project Cowbell), Dec 2020, Data on file (159847-201119 EMEA)
3. Ethicon, 03122020 Design Intent for ECHELON+ Anvil (Project Cowbell), Dec 2020, Data on file (159848-210510 EMEA, 159850-210510 EMEA)
4. Ethicon, PRC096858A Evaluation of Malformed Staples in Thick Tissue for Claims: Echelon Flex Powered Plus Stapler with GST vs Endo GIA and Signia with Tri-Staple Technology, Aug 2020, Data on file (158877-201112 EMEA)
5. Ethicon, PRC096436A Ex-Vivo Comparison of Staple Line Leak Pressure: Echelon Flex Powered Plus Stapler with GST vs Endo GIA and Signia with Tri-Staple Technology, Aug 2020, Data on file (173220-210408 EMEA)
6. Ethicon, PRC097500B.3 Cowbell Foam Uniform Compression Study for Claims: Cowbell Powered Plus with GST vs. Covidien Endo GIA with Tri-Staple, Oct 2020, Data on file (158247-201105 EMEA)
7. Ethicon, PSB004799 Tissue-device biomechanics during stapler firing: ETHICON ECHELON FLEX GST System vs. COVIDIEN SIGNIA Stapling System with Tri-Staple Technology, Sep 2018, Data on file Ethicon, SCN078248A Assessment of No Impact to existing evaluation of clinical evidence, Aug 2020, Data on file (158888-201112 EMEA)
8. Ethicon, PRC097776A Evaluation of stomach tissue movement during stapler firing for claims: Cowbell vs Signia, Nov 2020, Data on file (160327-201124 EMEA)
9. 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.
10. Miller DL, Roy S, Kassis ES, 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. Adv Ther. 2018 Apr 16.
11. Park SY, Kim DJ, Nam CM, et al. Clinical and Economic benefits Associated with the Use of Powered and Tissue-specific Endoscopic Staplers Among Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer. Journal of Medical Economics,
12. Roy S, Yoo A, Yadalam S, et al. Comparison of economic and clinical outcomes between patients undergoing laparoscopic bariatric surgery with powered versus manual endoscopic surgical staplers. Journal of Medical Economics. 2017; 20:4, 423-433, doi:13.1080/13696998.2017.1296453
13. Tsunezuka Y, Tanaka N, Fujimori H. The Impact of Endoscopic Stapler Selection on Bleeding at the Vascular Stump in Pulmonary Artery Transection. Med Devices (Auckl). 2020;13:41-47 https://doi.org/10.2147/MDER.S240343
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Last updated February 22, 2019. The third-party trademarks used herein are trademarks of their respective owners. Data and usage fees may apply. See your carrier for more information.
*As of March 2017, per internal research conducted by Ethicon.
Please refer always to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.