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“ECHELON Reloads with Gripping Surface Technology mean security to me, a certain peace of mind.”
Pr. David Nocca, MD, PhD, Bariatric Surgeon
All Surgical Stapling Products
References
*Benchtop testing in porcine tissue for ECHELON+ Stapler with GST Reloads. Reliable staple line integrity defined as 0.9 reliability at 90% confidence over the intended tissue thickness range for each reload. The Echelon+ Stapler with GST Reloads accommodates a tissue thickness range of 1.0mm to 4.0mm (measured at 8g/mm2, tissue comfortably compressed to closed staple height during firing per IFU)
† 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
‡ Based on articulation data from IFUs of each device.
§ Benchtop testing in porcine tissue at <34mmHg, comparing number of leaks of 11 for ECHELON CIRCULAR Powered Stapler (CDH29P) (n=30) to 21 for Medtronic EEA™ Circular Stapler with Tri-Staple™ Technology (TRIEEA28MT) (n=30), p<0.05, and preclinical perfusion model comparing means of 0.35085 (n=23) for CDH29P to 0.32665 (n=23) for TRIEEA28MT, p<0.05
¶ Unique curved head design gives low pelvic access.
β Large-scale is defined as sample size greater than 3,500 cases.
€ 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]
\\ A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses, N=168
1. Ethicon, PRC093801A Project Cowbell 45mm GST Reload SLI/FSH DV Completion Report, April 2020, Data on file Ethicon, PRC095237B Project Cowbell 60mm GST Reload SLI/FSH DV Completion Report, July 2020, Data on file Ethicon, 18082020 ECHELON+ with GST Reloads Tissue Thickness Range Memo, Aug 2020, Data on file (167038-211112 EMEA)
2. Ethicon, PRC096436A Ex-Vivo Comparison of Staple Line Leak Pressure: Echelon Flex Powered Plus Stapler with GST vs EndoGIA 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 Tri-Staple Technology, Aug 2020, Data on file (159504-201117 EMEA)
3. Ethicon, PRC067966A ECHELON FLEX™ Powered Vascular Stapler Commercial Claims Completion Report 2, Oct 2014, Data on file Ethicon, PRC068229A ECHELON FLEX™ Powered Vascular Stapler Commercial Claim Sub-Completion Report 1, Sep 2014, Data on file (128776-211115 EMEA)
4. Ethicon, PRC097405A Echelon Circular Powered Stapler Leak Claims Testing, Sep 2020, Data on file Ethicon, 500669863A Echelon Circular Powered Stapler Perfusion Testing Completion Report , May 2021, Data on file (184966-210803 EMEA)
5. Ethicon, PRC093434A Silhouette Pelvic Access [Claims], March 2020, Data on file (162307-201209 EMEA)
6. Rawlins L, Johnson BH, Johnston S, Elangovanraaj N, et al. Comparative effectiveness assessment of two powered surgical stapling platforms in laparoscopic sleeve gastrectomy: a retrospective matched study. Med Devices (Auckl). 2020;13:195-204.
7. Roy S, Yoo A, Yadalam S, et al. Comparison of economic and clinical outcomes between patients undergoing laparoscopic bariatric surgery with powered vs. manual endoscopic surgical staplers. J Med Econ. 2017;20(4):423-433.
8. 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.
9. Park SY, Kim DJ, Mo Nam C, 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. J Med Econ. 2019;22(12):1274-1280.
10. Miller D, Roy S, Kassis E, Yadalam S, Ramisetti S, Johnston S. 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;35(5):707-723.
11. Pla-Martí V, Martín-Arévalo 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. Tech Coloproctol. 2021;25(3):279-284
12. Herzig DO, Ogilvie JW, Chudzinski A, et al. Assessment of a circular powered stapler for creation of anastomosis in left-sided colorectal surgery: A prospective cohort study. Int J Surg. 2020;84:140-146.
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*As of March 2017, per internal research conducted by Ethicon.
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