Ethicon Launches New Echelon+ Stapler With GST Reloads To Increase Staple Line Security And Reduce Complications In Surgery

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Device Designed for More Uniform Tissue Compression, Better Staple Formation and Fewer Staple Line Leaks than Other Surgical Staplers, Even in Challenging Clinical Situations 1,2,3

Cincinnati, OH – March 24th 2021 – Ethicon*, part of the Johnson & Johnson Medical Devices Companies** today announced the global launch of the ECHELON+ Stapler with GST Reloads, a new powered surgical stapler designed to increase staple line security and reduce complications through more uniform tissue compression and better staple formation, even in challenging situations. 2,3  

20024_ECHELON+ Image with Callouts_3.5x2.5in_option 2_v1aThe ECHELON+ Stapler is the latest addition to the company’s market-leading ECHELON Powered Stapler portfolio.  The portfolio has been associated with improved clinical and economic outcomes including fewer bleeding complications, reduced hospital costs and improved efficiency across, procedures, patient populations and countries in large-scale retrospective studies.4,5,6,7,8  

Several innovative design features distinguish the new device from previous staplers including a reengineered ECHELON+ Anvil, that with Gripping Surface Technology (GST) Reloads, is designed for more uniform compression to better capture and form staples, as well as a new motor with Dynamic Firing, which optimizes firing speed in thick tissue to enhance compression and improve audible feedback. In recent benchtop testing, the ECHELON+ Stapler outperformed Medtronic’s Signia and EndoGIA Staplers with Tri-Staple Reloads providing better staple formation and reducing leaks at the staple line.2,9 

“The ECHELON+ Stapler is a meaningful innovation that addresses a key concern of bariatric surgeons, improving staple line security to help reduce complications,” said Joseph Northup, MD, Medical Director, Premier Weight Loss Solutions***. 

Despite recent advances in surgical stapling technology, perioperative complications persist across specialties.  Complications are driven primarily by postoperative anastomotic leaks and bleeding-related complications which may occur in up to 12% of colorectal resections  and in 2% to 10% of lobectomies, respectively.11,12   

“The launch of the ECHELON+ Stapler with GST Reloads is another milestone in our continuing commitment to evidence-based innovation that can enhance the surgeon’s experience, improve patient outcomes and deliver meaningful clinical and economic value. Our goal is to always elevate the standard of surgical care,” said Tom O’Brien, Worldwide Endomechanical President, Ethicon. 

About Ethicon
Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care 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 worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

About Johnson & Johnson Medical Devices Companies 
At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere. 
 
Cautions Concerning Forward-Looking Statements 
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the ECHELON CIRCULAR Powered Stapler. 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., any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; 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 30, 2018, 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. Neither Ethicon, Inc. the Johnson & Johnson Medical Devices Companies] nor Johnson & Johnson undertakes 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.

** The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.

*** Joseph Northup, MD is a paid consultant for Ethicon

1. Benchtop testing in porcine tissue ≤ 52mmHg (Double the 26mmHG average pressure experienced during intra-operative leak test), comparing Ethicon ECHELON+ Stapler PSEE60A with GST Reloads GST60B to Medtronic Signia Stapler with Tri-Staple Reloads EGIA60AMT and Medtronic EndoGIA with Tri-Staple Reloads EGIA60AMT. Cumulative number of leaked tests (14/30), (23/30), (25/30) respectively, n=30 p < 0.05. (150356-200818).

2. Benchtop testing in 3.2mm synthetic tissue comparing staple line compression between ECHELON+ Stapler with GST Reloads (PSEE60A, GST60B,GST60G) to Medtronic Signia™ and Endo GIA™ Staplers with Tri-Staple™ Reloads (EGIA60AMT). Resulting in a statistically significant compression uniformity, p<0.05. (155751-201014).

3. 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. (151140-200826).

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

5. Miller DL, Roy S, Kassis ES, et al. 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 Apr 16. doi: 10.1007/s12325-018-0679-z

6. Park SY, Kim DJ, Nam CM, et al. Clinical and Economic benefits Associated with the Use of Powered and Tissue-specific Endoscopic Staplers Among Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer. Journal of Medical Economics, doi: 10.1080/13696998.2019.1634081

7. 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; 20:4, 423-433, doi:10.1080/13696998.2017.1296453

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 https://doi.org/10.2147/MDER.S240343

9. Benchtop testing in porcine tissue ≤ 30mmHg (26mmHG average pressure experienced during intra-operative leak test), comparing Ethicon ECHELON+ Stapler PSEE60A with GST Reloads GST60B to Medtronic Signia™ and Endo GIA™ Staplers with Tri-Staple Reloads EGIA60AMT, p < 0.05. (150352-200818).

10. Koianka T, Kevin M. Martin W, et al. Identifying Important Predictors for Anastomotic Leak After Colon and Rectal Resection. Annals of Surgery. 2013; 257:108. 

11. Kent M, et al. Open, video-assisted thoracic surgery, and robotic lobectomy: review of a national database. Ann Thorac Surg. 2014;97:236-444. 

12. Based on Ethicon (2016) internal analysis of data from 26,955 lobectomy procedures captured in Premier Perspective database for the period of 2008-2014.