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Ongoing Innovation to Reduce Complications
Ongoing Innovation to Reduce Complications
Our surgical stapling portfolio addresses the challenges of tissue thickness, tissue movement during firing, staple line security, and tissue tension with the objective of providing greater stapling precision in surgery.
Improving outcomes with a scientific approach to stapling and evaluating the impact with evidence – our portfolio goes "beyond the benchtop," using real-world evidence in colorectal, bariatric and thoracic surgery.
“ECHELON Reloads with Gripping Surface Technology mean security to me, a certain peace of mind.”
Pr. David Nocca, MD, PhD, Bariatric Surgeon
Body of Evidence: Colorectal
Put the power to reduce leaks in your hands.11€ ECHELON CIRCULAR demonstrated an 1.8% anastomotic leak rate in a multi-site, multi-country clinical study.12\\ In a separate clinical study, it demonstrated an 1.7% anastomotic leak rate, which was an 85% reduction compared to manual circular staplers (1.7% vs. 11.8%, p=0.002).11€
All Surgical Stapling Products
Shaping the future of surgery
At Ethicon, we’re focused on improving health outcomes for patients and helping solve the greatest health challenges… with meaningful innovation. The kind that led to the creation of the first sutures, helped revolutionize surgery with minimally invasive procedures and elevate the standards of care around the world.
*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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