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Product is capable of delivering 47% fewer leaks at the staple line to help reduce surgical risks.
May 28, 2024
By: Michael Barbella
Managing Editor
Ethicon* has officially launched the ECHELON LINEAR Cutter in the United States. The company claims ECHELON is the first linear cutter to market with combined innovative and proprietary technologies: 3D-stapling technology and gripping surface technology (GST)—two advanced capabilities proven to enable greater staple line security, which can help surgeons reduce risks and support patient outcomes. Backed by science, this surgical stapler delivered 47% fewer leaks at the staple line to help reduce surgical risks.i,*** Its unique design provides surgeons with the option to keep the device halves locked, or to separate them, offering more control of the device placement when navigating the differing needs of each patient’s anatomy.i,ii,****,***** In colorectal surgery, an anastomosis is a critical part of the procedure in which two ends of the colon are connected with staples after part of the organ has been resected or removed due to damage or disease. If this connection is faulty or weak, an anastomotic leak may occur, which can lead to lengthier hospitalization, increased healthcare costs, and/or death.iii,iv Studies show the mortality rate associated with anastomotic leaks can range from 10% to 15%.v The risk of death can be three to eight times greater if an anastomotic leak is present.vi,vii “Today, surgeons are treating an aging population as well as patients who are increasingly obese and presenting with comorbidities that can negatively impact surgical outcomes. This requires surgeons to manage various tissue types and navigate difficult-to-access anatomy, raising the risk of complications,” said Sandeep Makkar, global president of Ethicon Energy and Endomechanical. “Informed by surgeon experience, we’re pleased to add the new ECHELON LINEAR Cutter to the portfolio given its first-of-its-kind design to provide surgeons with greater control, while also leveraging our proven GST and 3D-stapling technologies to help reduce surgical risks.” Complications associated with colorectal surgery can be severe, with anastomotic leaks remaining the most serious due to the dramatically increased associated risks of postoperative mortality and the need for a permanent stoma.iii “… it’s imperative that we continue innovating with purpose to help solve for the challenges surgeons are facing and make an impact along the continuum of care,” Makkar added. The ECHELON LINEAR Cutter is the latest colorectal surgical solution added to the ECHELON portfolio, bringing forward similar stapling capabilities in advancing staple line security as ECHELON CIRCULAR Powered Stapler and ECHELON 3000. ECHELON LINEAR Cutter will soon be added to a clinical and real-world evidence program for advanced stapling that includes the publication of nine peer-reviewed studies in seven countries spanning more than 700 hospitals and over 46,000 patients, as clinical evidence is generated post-launch. The ECHELON LINEAR Cutter’s design and development was informed by input from surgeons, as well as Ethicon’s deep understanding of the properties of living tissue and its interaction with devices. It’s these insights—coupled with a purpose-driven approach to innovation—that have resulted in the product’s greater device control, staple line integrity and staple consistency, ultimately helping to drive improved patient outcomes. “The most critical safeguard of a successful operation is managing surgical risks wherever possible, and the advanced technologies behind ECHELON devices help our surgical team to do that,” said Dr. Shekar Narayanan, a board-certified colon and rectal surgeon and chief of Surgical Oncology at Community Health Network. “The combined technology of an ECHELON stapler plus GST reloads and 3D Stapling are remarkable in their ability to stabilize and compress tissue and reduce slippage, all of which are critical factors in reducing the potential for complications during colorectal surgery.” Ethicon partners with hospitals, surgeons, and surgical staff to capture the learnings gained from performing countless procedures to address unmet clinical needs and deliver on the promise of digital surgery. Its latest technologies and training connect the knowledge, resourcefulness, and deep experience across the continuum of care for more informed decision making and better connectivity on behalf of patients pre- and post-operatively. ECHELON Gripping Surface Technology (GST) is designed to stabilize and compress tissue where it is needed, resulting in lower potential of tissue slippage versus traditional linear cutters. 3D Stapling Technology has offset staple legs designed to distribute tissue compression load more evenly over a greater surface area and reduce potential leak pathways. Together these advanced stapling technologies offer staple line integrity across a broad range of tissue thicknesses. Ethicon is a a Johnson & Johnson MedTech company that develops clinically-differentiated surgical technologies and solutions to help address health challenges like metabolic disease, cardiovascular disease and cancer. Johnson & Johnson MedTech drives scientific innovation to address unmet needs in surgery, orthopedics, vision, and interventional solutions. *Ethicon represents the products and services of Ethicon Inc., Ethicon Endo-Surgery LLC and certain of their affiliates. All other trademarks are the property of their respective owners. **Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment. *** Benchtop testing on porcine colon measuring staple line leak rate at 30mmHg, comparing rates of 52.8% for Medtronic GIA with TriStaple, Ethicon Linear Cutter, and Proximate Linear Cutter to 27.7% for Echelon Linear Cutter (n=36, p<0.001) **** Surgeon usability evaluation of one-handed positioning and placement when the halves are locked. ***** Greater control supported by a surgeon usability evaluation = 65% agreed, n=37. Dr. Shekar Narayanan is a paid consultant for Ethicon who has not been compensated for any media work. References i Ethicon. Echelon Linear Cutter (Cornerstone) Staple Line Leak Claims Testing. 1/28/2022. Windchill #500897557 Ethicon. ii Echelon Linear Cutter (Cornerstone) Customer Usability Claim Summary Report. 7/15/2022. Windchill #501027381 iii Trencheva K, Morrissey K, Wells M, et al. Identifying Important Predictors for Anastomotic Leak After Colon and Rectal Resection. Annals of Surgery. 2013; 257: 108. iv Schiff A, Brady BL, Ghosh SK, et al. Estimated Rate of Post-Operative Anastomotic Leak Following Colorectal Resection Surgery: A Systematic Review. Journal of Surgery and Surgical Research. 2016;2(1): 060-067. v Hyman, Neil MD; Manchester, Thomas L. MD; Osler, Turner MD; Burns, Betsy NP; Cataldo, Peter A. MD; Annals of Surgery: February 2007 – Volume 245 – Issue 2 – p 254-258 doi: 10.1097/01.sla.0000225083.27182.85 vi Gessler B, Eriksson O, Angenete E. Diagnosis, treatment, and consequences of anastomotic leakage in colorectal surgery. Int J Colorectal Dis .2017. 32:549–556. DOI 10.1007/s00384-016-2744-x vii Turrentine F, Denlinger C, Simpson V. Morbidity, Mortality, Cost, and Survival Estimates of Gastrointestinal Anastomotic Leaks. J Am Coll Surg. 2015. DOI: /10.1016/i.jamcollsurg.2014.11.002
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