Ethicon08.06.20
According to a real-world evidence study comparing the two leading powered surgical stapling systems, Ethicon’s Echelon Powered Stapler with Gripping Surface Technology (GST) reloads was associated with a lower rate of bleeding-related complications than Medtronic’s Signia Stapling System with Tri-Staple among patients undergoing laparoscopic sleeve gastrectomy for obesity.
The peer-reviewed study, which appears online in Medical Devices: Evidence and Research, was funded by Ethicon, part of the Johnson & Johnson Medical Devices Companies.
Ethicon has now sponsored six, large-scale, retrospective real-world studies on clinical outcomes associated with Echelon Powered Staplers. The research, which spans four countries and more than 41,000 patients, showed a reduction in both bleeding complications and hospital costs when Echelon Powered Staplers are used versus other leading surgical staplers.
Findings of the Study
In the latest study, researchers found bleeding complication rates were up to 73% lower in the Echelon Powered Stapler with GST reloads group than they were in the Signia group (0.61% vs. 2.24%).1 The complication rate associated with Echelon Powered Staplers was below the national average for the bariatric procedure, which previous studies have shown to range from 1.16% to 4.94%.2 While bleeding complications are not common, they can be life threatening.3
The study also found median total hospital costs were approximately 7% lower for the Echelon Powered Stapler with GST reloads group4 – although the difference was not significant for mean total hospital costs. Differences between the two stapler groups for length of stay, operating room time and all-cause inpatient readmissions within 90 days were also not statistically significant.
The study authors used the Premier Healthcare Database of U.S. hospital discharge records to identify and analyze the real-world outcomes of 982 inpatient sleeve gastrectomy patients (491 Echelon Powered Stapler with GST and 491 Signia System with Tri-Staple) matched for patient and hospital/provider characteristics from a pool of 5,573 patients who had the procedure between March 2017 and December 2018.
“While the study demonstrated that Echelon Powered Stapler with GST reloads was associated with lower hemostasis related complications, further analysis is required to determine why. What we do know is stapler selection in bariatric surgery could be very important. The differences in stapler design can correlate with outcomes and complications following bariatric surgery,” said lead study author Michael “Logan” Rawlins, MD, a bariatric surgeon with the Allegheny Health Network Bariatric & Metabolic Institute in Pittsburgh, PA.
The study authors noted, “Whereas (Echelon) GST stabilizes and controls tissue movement through a multi-stage compression, gripping surface technology, and surgeon-controlled power; Signia with Tri-Staple has more tissue movement through a single-stage compression, a stepped cartridge and device-controlled power, thus potentially having different tissue effects intra and postoperatively.”
The Echelon Powered Stapler with GST reloads provides a better way to staple due to its gripping surface technology, 2-stage compression and ability to handle a broad range of tissue thicknesses. The Echelon Powered Stapler with GST reloads delivered 4-times less tissue slippage and can accommodate the broadest range of tissue thicknesses compared to Medtronic staplers.5,6 It is the only surgical stapling brand backed by large-scale, real-world, peer-reviewed evidence.7
“Ethicon is committed to improving outcomes and reducing complication rates in surgery through an evidence-based approach to elevate standard of care. Our approach encompasses understanding of the disease state, impact of surgical techniques, science of device-tissue interaction, innovative stapler design and professional education,” said Sanjoy Roy, director, global health economics and market access, Ethicon Inc. and a co-author of the study.
References:
1. 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. Analysis of hemostasis-related complication outcomes from 982 laparoscopic sleeve gastrectomy cases between March 1, 2017 and December 31, 2018 from Premier Healthcare Database (0.61% versus 2.24%, p=0.0012).
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5339325/#:~:text=Discussion,the%20abdominal%20wall%20%5B12%5D.
3. https://www.sages.org/meetings/annual-meeting/abstracts-archive/risk-factors-and-outcomes-for-bleeding-following-bariatric-surgery-results-from-the-metabolic-and-bariatric-surgery-accreditation-and-quality-improvement-program-mbsaqip/
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. Analysis of median total hospital cost outcomes from 982 laparoscopic sleeve gastrectomy cases between March 1, 2017 and December 31, 2018 from Premier Healthcare Database ($9,771 vs. $10,487, p=0.184)
5. 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 3.3 and 4.0mm tissue thicknesses (3.3mm: GST60T 0.642mm vs EGIA60AMT 4.806mm p<0.001; 4.0mm: GST60T 0.654mm vs EGIA60AXT 5.116mm p<0.001).
6. Comparison of the ECHELON FLEX™ GST System designed to accommodate a compressed tissue thickness range of 1.0mm to 4.0mm vs the Medtronic Tri-Staple portfolio intended for a thickness range of 0.75mm to 3.0mm (Medtronic literature, downloaded from Medtronic website on Nov 16, 2016).
7. Based on literature search performed May 2019. Large-scale is defined as sample size greater than 3,500 cases.
The peer-reviewed study, which appears online in Medical Devices: Evidence and Research, was funded by Ethicon, part of the Johnson & Johnson Medical Devices Companies.
Ethicon has now sponsored six, large-scale, retrospective real-world studies on clinical outcomes associated with Echelon Powered Staplers. The research, which spans four countries and more than 41,000 patients, showed a reduction in both bleeding complications and hospital costs when Echelon Powered Staplers are used versus other leading surgical staplers.
Findings of the Study
In the latest study, researchers found bleeding complication rates were up to 73% lower in the Echelon Powered Stapler with GST reloads group than they were in the Signia group (0.61% vs. 2.24%).1 The complication rate associated with Echelon Powered Staplers was below the national average for the bariatric procedure, which previous studies have shown to range from 1.16% to 4.94%.2 While bleeding complications are not common, they can be life threatening.3
The study also found median total hospital costs were approximately 7% lower for the Echelon Powered Stapler with GST reloads group4 – although the difference was not significant for mean total hospital costs. Differences between the two stapler groups for length of stay, operating room time and all-cause inpatient readmissions within 90 days were also not statistically significant.
The study authors used the Premier Healthcare Database of U.S. hospital discharge records to identify and analyze the real-world outcomes of 982 inpatient sleeve gastrectomy patients (491 Echelon Powered Stapler with GST and 491 Signia System with Tri-Staple) matched for patient and hospital/provider characteristics from a pool of 5,573 patients who had the procedure between March 2017 and December 2018.
“While the study demonstrated that Echelon Powered Stapler with GST reloads was associated with lower hemostasis related complications, further analysis is required to determine why. What we do know is stapler selection in bariatric surgery could be very important. The differences in stapler design can correlate with outcomes and complications following bariatric surgery,” said lead study author Michael “Logan” Rawlins, MD, a bariatric surgeon with the Allegheny Health Network Bariatric & Metabolic Institute in Pittsburgh, PA.
The study authors noted, “Whereas (Echelon) GST stabilizes and controls tissue movement through a multi-stage compression, gripping surface technology, and surgeon-controlled power; Signia with Tri-Staple has more tissue movement through a single-stage compression, a stepped cartridge and device-controlled power, thus potentially having different tissue effects intra and postoperatively.”
The Echelon Powered Stapler with GST reloads provides a better way to staple due to its gripping surface technology, 2-stage compression and ability to handle a broad range of tissue thicknesses. The Echelon Powered Stapler with GST reloads delivered 4-times less tissue slippage and can accommodate the broadest range of tissue thicknesses compared to Medtronic staplers.5,6 It is the only surgical stapling brand backed by large-scale, real-world, peer-reviewed evidence.7
“Ethicon is committed to improving outcomes and reducing complication rates in surgery through an evidence-based approach to elevate standard of care. Our approach encompasses understanding of the disease state, impact of surgical techniques, science of device-tissue interaction, innovative stapler design and professional education,” said Sanjoy Roy, director, global health economics and market access, Ethicon Inc. and a co-author of the study.
References:
1. 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. Analysis of hemostasis-related complication outcomes from 982 laparoscopic sleeve gastrectomy cases between March 1, 2017 and December 31, 2018 from Premier Healthcare Database (0.61% versus 2.24%, p=0.0012).
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5339325/#:~:text=Discussion,the%20abdominal%20wall%20%5B12%5D.
3. https://www.sages.org/meetings/annual-meeting/abstracts-archive/risk-factors-and-outcomes-for-bleeding-following-bariatric-surgery-results-from-the-metabolic-and-bariatric-surgery-accreditation-and-quality-improvement-program-mbsaqip/
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. Analysis of median total hospital cost outcomes from 982 laparoscopic sleeve gastrectomy cases between March 1, 2017 and December 31, 2018 from Premier Healthcare Database ($9,771 vs. $10,487, p=0.184)
5. 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 3.3 and 4.0mm tissue thicknesses (3.3mm: GST60T 0.642mm vs EGIA60AMT 4.806mm p<0.001; 4.0mm: GST60T 0.654mm vs EGIA60AXT 5.116mm p<0.001).
6. Comparison of the ECHELON FLEX™ GST System designed to accommodate a compressed tissue thickness range of 1.0mm to 4.0mm vs the Medtronic Tri-Staple portfolio intended for a thickness range of 0.75mm to 3.0mm (Medtronic literature, downloaded from Medtronic website on Nov 16, 2016).
7. Based on literature search performed May 2019. Large-scale is defined as sample size greater than 3,500 cases.
