New device combines Ethicon’s proven Gripping Surface Technology (GST) and 3D-stapling technology for greater staple line integrity
CINCINNATI, OH – May 27, 2024 – Ethicon*, a Johnson & Johnson MedTech** company, today announced the U.S. launch of the ECHELON LINEAR™ Cutter. It 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 first-of-its-kind 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 3- to 8-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 “As a leader in MedTech, it’s imperative that we continue innovating with purpose to help solve for the challenges surgeons are facing and make a profound impact along the continuum of care,” Makkar added.
Dr. Shekar Narayanan, board-certified colon and rectal surgeon and Chief of Surgical Oncology at Community Health Network, added: “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.”
“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,” he continued.
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 design and development of the ECHELON LINEAR™ Cutter 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.
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 transformative promise of digital surgery. Its latest technologies and state-of-the-art training connect the vast 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.
For additional information about the ECHELON LINEAR™ Cutter, visit ethicon.com/LinearCutter
About Ethicon’s Gripping Surface Technology (GST) and 3D-Stapling Technology
ECHELON Gripping Surface Technology (GST) is designed to stabilize and compress the 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 exceptional staple line integrity across the broadest range of tissue thicknesses giving surgeons more flexibility to meet their needs in the OR.
About Ethicon
At Ethicon, a Johnson & Johnson MedTech company, putting humanity at the core of care is our passion and our purpose. In collaboration with clinicians and health care experts around the world, we develop clinically-differentiated surgical technologies and solutions to help address some of the most pressing health challenges of our time such as metabolic disease, cardiovascular disease and cancer. Through our efforts and ingenuity, we aspire to elevate standards of care and create a healthier future for the patients of today and tomorrow. Visit www.ethicon.com to learn more about us.
About Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. For more, visit https://thenext.jnjmedtech.com.
Cautions Concerning Forward-Looking Notices
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc., Ethicon Endo-Surgery, LLC, Ethicon Endo-Surgery, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Ethicon, Inc., Ethicon Endo-Surgery, LLC, Ethicon Endo-Surgery, Inc., nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.
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*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.
Dr. Matthew Albert is a paid consultant for Ethicon. He has not been compensated for any media work.
Dr. Shekar Narayanan is a paid consultant for Ethicon. He has not been compensated for any media work.
Footnotes:
*** 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.
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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