New Study Highlights Impact of Surgical Staplers on Tissue and Staple-Line Healing

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New Study Highlights Impact of Surgical Staplers on Tissue and Staple-line Healing

Ethicon ECHELON FLEX™ GST System is associated with a stronger staple line and higher leak pressures when compared to Endo GIA™ Reload with Tri-Staple™ Technology

GST InfographicCINCINNATI, OH – October 22, 2018 –. Ethicon, part of Johnson & Johnson Medical Device Companies, and a leading global provider of medical devices, is continuing to invest in research aimed at minimizing complications and improving surgical outcomes.  Ethicon’s research strategy includes a mix of clinical, pre-clinical and real-world evidence to support the development of innovative products that help reduce patient risk factors. As part of this commitment, Ethicon announced a first-of-its-kind study published in Obesity Surgery that evaluates how the interaction between the surgical stapler and tissue may impact staple-line integrity and leak pressure.  

Anastomotic leaks, although rare, are a leading cause of morbidity and mortality in gastrointestinal surgery, and staple-line integrity is an important factor in preventing the complications of these leaks. To better understand how stapling devices may impact leaks in gastrointestinal surgery, Ethicon initiated a study to assess how capturing all layers of the tissue, including the mucosa, in the staple line influences staple-line and anastomotic integrity. The mucosa layer, the inner most lining of the gastrointestinal tract, provides a barrier that prevents bacteria from entering the internal tissues, therefore helping to limit infections. This study, “Initial Assessment of Mucosal Capture and Leak Pressure After Gastrointestinal Stapling in a Porcine Model1, found that there are differences in the degree of mucosal capture between commercial staplers and that there is a relationship between mucosal capture, leak site location and initial leak pressure.

The study demonstrated that the Ethicon ECHELON FLEX™ GST System, as compared to Medtronic’s Endo GIA™ Reload with Tri-Staple™ Technology, more consistently captured all layers of tissue in the staple line, promoting conditions for tissue healing. This study is the first to show that the degree of mucosal capture may play a role in initial leak pressure, supported by the fact that first leak occurred predominately in the areas where mucosal capture was poor. This suggests mucosal capture may be an important factor in initial staple line and anastomotic integrity.  Further research is needed to determine the significance of these findings on staple-line healing throughout the postoperative period

Ethicon shares a commitment with surgeons to improve patient outcomes and to ensure that our products deliver the best outcomes in real-world use. Ethicon strives to reduce complications by designing tissue specific products, validating them with evidence, deeply understanding the effects on tissue, and using those insights to guide future innovation.  

“Evidence matters and is at the heart of everything we do,” says Tom O’Brien, Vice President, Global Endomechanical Platform Leader at Ethicon. “We’ve taken this evidence-based approach across our entire portfolio so that our devices are poised to deliver the best outcomes for patients all over the world.”

An example of this commitment can be found in one of the largest retrospective studies of surgical stapling ever conducted, “Comparison of Economic and Clinical Outcomes between Patients Undergoing Laparoscopic Bariatric Surgery with Powered vs. Manual Endoscopic Surgical Staplers2, discharge data from the Premier Healthcare Database was analyzed on over 21,000 bariatric patients and demonstrated that ECHELON FLEX™ Powered Staplers are associated with significantly reduced hemostasis-related complications as well as total hospital costs in bariatric procedures.‡,§

Ethicon will continue to invest in evidence to continuously drive a greater understanding of the science of device and tissue interaction and use our expertise to improve products with the ultimate goal of improving patient outcomes. 

The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, interventional and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

About Ethicon

From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing healthcare issues, and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.

 

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References

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. Ethicon Endo-Surgery, Inc. is the legal manufacturer of ECHELON FLEX™ Powered Staplers. All other trademarks are the property of their respective owners.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.
†ECHELON™ GST System 60mm Blue and Green Reloads compared to Endo GIA with Tri-Staple™ Technology 60mm Purple Reloads evaluated via gross observations of firings in 1.5mm to 3.0mm thick animate porcine ileum.  Additional testing demonstrated no significant performance difference between 60mm and 45mm reloads of the same brands.
‡Use of Ethicon powered staplers was associated with fewer bleeding / transfusion complications (1.61%) compared to Medtronic non-powered staplers (3.05%), p=0.010, in laparoscopic Sleeve Gastrectomy and Roux-en-Y Gastric Bypass procedures. Based on retrospective analysis of 21,466 cases from the Premier Perspective® Hospital Database.
§Use of Ethicon powered staplers was associated with lower overall hospital costs ($12,261) compared to Medtronic non-powered staplers ($14,038), p=0.022, in laparoscopic Sleeve Gastrectomy and Roux-en-Y Gastric Bypass procedures. Based on retrospective analysis of 21,466 cases from the Premier Perspective® Hospital Database.

  1. Thompson S, Young M, Lewis M, et al. Initial Assessment of Mucosal Capture and Leak Pressure After Gastrointestinal Stapling in a Porcine Model. Obesity Surgery. 2018 June. https://doi.org/10.1007/s11695-018-3363-0
  2. 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 Apr; 20(4): 423-433. http://dx.doi.org/10.1080/13696998.2017.1296453