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25.09.2019 – 08:01

ETHICON, INC.

Ethicon Launches New Powered Circular Stapler With Dual Technologies to Reduce Anastomotic Complications in Colorectal, Gastric, and Thoracic Surgery

Vienna (ots/PRNewswire)

Innovative technology helps address critical challenge of anastomotic leaks which can occur in up to 8.6% of colorectal surgeries1,11% in oesophagectomies2 and 4% in gastrectomies3

Ethicon*, part of the Johnson & Johnson Medical Devices Companies**, today announced the launch of the ECHELON CIRCULAR(TM) Powered Stapler - the new powered circular stapler which utilises an innovative Gripping Surface and 3D Stapling Technologies. It is now available across Europe, the Middle East and Africa and will be commercially launched at the European Society of Coloproctology's (ESCP) 14th Annual Meeting in Vienna, 25-27 September 2019.

Anastomosis is the process of surgically connecting two structures and is performed after resection of part of the gastrointestinal tract to connect the remaining sections. It is a critical step in surgery and has a high risk for complications. Tissue tension, poor blood supply and variable tissue thickness can compromise the anastomosis which can lead to significant complications, such as anastomotic leaks. The causes are complex, including patient, surgical and technological factors.

"Improving the chances to effectively stop an anastomotic leak is our duty to our patients," said Professor Tan Arulampalam, Consultant General Surgeon, NHS. "The time to act is now, this is a problem that we cannot ignore any longer."

In colorectal surgery the rate of an anastomotic leak varies widely, with some rates as high as 39%4, however a recent international study estimated the overall rate of anastomotic leak to be 8.6%1. Anastomotic leaks can reduce patient 5-year overall survival rates to as low as 33.3%5. Furthermore, patients with anastomotic leaks had a longer hospital stay6 and up to 95% required low anterior resection (LAR) reoperation7. The impact on overall healthcare costs varies, albeit costly and in some cases can result in an additional cost to the procedure up to EUR35,000 +/- 1.500 per patient8.

"We are really excited to be launching the ECHELON CIRCULAR(TM), the first ever Powered Circular Stapler of its kind," stated Said Haddad, Vice President ETHICON, EMEA. "This is just another example of how focused we are on reaching new frontiers in surgery and aiming to make a positive difference to patient outcomes with innovative technologies. We're confident that ECHELON CIRCULAR(TM) will have a significant impact on surgical experiences and improve outcomes of many patients, even in the most complex of procedures."

In preclinical studies, the new ECHELON CIRCULAR(TM) Powered Stapler was shown to significantly reduce leaks at the staple line without compromising perfusion9,¥, compared to the Medtronic Manual DST Series(TM) EEA(TM) Stapler. This is in part due to two innovative technologies: Gripping Surface Technology, a proprietary ridge surface, which provides gentler handling with a 33% reduction in compressive forces on tissue10,?, and 3-Dimensional Stapling Technology designed to evenly distribute compression throughout the anastomosis11,?.

Built on a powered firing platform, the ECHELON CIRCULAR Powered Stapler had 37% less movement at the distal tip for increased stability12,§ and reduces the force to fire by 97% compared to the Covidien (Medtronic) Manual DST Series(TM) EEA(TM) Stapler13,#. The new ECHELON CIRCULAR Powered Stapler is also designed with safety features that may help to minimize variation in usage and standardize performance across users14.

Ethicon and the new ECHELON CIRCULAR Powered Stapler will be on Stand #54 at ESCP 2019 in Vienna, Austria (25-27 September).

For further information about the product, visit http://bit.ly/2mNCdIN

Notes to Editors

About Ethicon

Ethicon, part of the 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 adjunctive hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit https://www.jnjmedicaldevices.com/en-EMEA/companies/ethicon

About the Johnson & Johnson Medical Devices Companies

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.

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates.

**Comprising the surgery, orthopaedics, and interventional solutions businesses within the Johnson & Johnson's Medical Devices segment.

¥Benchtop testing in porcine tissue <=30mmHg (26mmHg average pressure experienced during intra-operative leak test), comparing Ethicon CDH29P to Medtronic (Covidien) manual EEA2835 (p<0.001) and preclinical perfusion model, in which perfusion was not significantly different between devices.

?Benchtop testing on porcine colon, comparing Ethicon CDH29P to Covidien (Medtronic) manual EEA2835, p<0.001.

?Staple line analysis in benchtop testing, comparing Ethicon CDH25P to Covidien (Medtronic) manual EEA2535.

§Users firing in a porcine model, comparing Ethicon CDH29P to Medtronic Covidien manual EEA2835, p=0.003.

#Benchtop testing, comparing Ethicon CDH29P to Medtronic Covidien EEA2835, p=0.001.

References:

1. The European Society of Coloproctology collaborating group (2018). The 2017 European Society of Coloproctology (ESCP) international snapshot audit of left colon, sigmoid and rectal resections - Executive Summary. Colorectal Dis Suppl 6:13-14

2. Kassis E, Kosinski A, Ross P, et al. Predictors of anastomotic leak after esophagectomy: an analysis of the society of thoracic surgeons general thoracic database. Ann Thorac Surg. 2013; 96:1919

3. Oh SJ, Choi WB, Song J. et al. Complications requiring reoperation after gastrectomy for gastric cancer: 17 years experience in a single institute. J Gastrointest Surg. 2009; 13:239

4. Nordentoft, T, Pommergaard, H-C, Rosenberg, J, Achiam, MP (2015). Fibrin Glue Does Not Improve Healing of Gastrointestinal Anastomoses: A Systematic Review. Eur Surg Res 54:1-13

5. Marra, F, Steffen, T, Kalak, N, et al. (2009) Anastomotic leakage as a risk factor for the long-term outcomes after curative resection of colon cancer. Eur J Surg Oncol 35: 1060-64

6. Schiff, A, Roy, S, Pignot, M, Ghosh, K, Fegelman, EJ (2017) Diagnosis and management of intraoperative colorectal anastomotic leaks: A global retrospective patient chart review study. Surg Res Pract Article ID 3852731

7. Buchs, NC, Gervaz, P, Secic, M, Bucher, P, Mugnier-Konrad, B, Morel, P (2008) Incidence, consequences, and risk factors for anastomotic dehiscence after colorectal surgery: a prospective monocentric study. Int J Colorectal Dis 23:265-70

8. Zoucas, E, & Lydrup, ML (2014) Hospital costs associated with surgical morbidity after elective colorectal procedures: a retrospective observational cohort study in 530 patients. Patient Saf Surg 8:2

9. Ethicon, PRC077848 Leak Claims Testing, October 2016, Data on File. Ethicon, PSB004557 A comparison of staple line perfusion between 29mm ECHELON CIRCULAR(TM) Powered Stapler (CDH29P) and 28mm DST Series(TM) EEA(TM) Circular Stapler (EEA2835), November 2016, Data on File (114092-190513 EMEA)

10. Ethicon, PRC078621 Echelon Powered Circular Gentler Handling Test Completion Report, January 2017, Data on File (115224-190528 EMEA)

11. Ethicon, PRC078258 Even Compression Claims Testing, November 2016, Data on File (115263-190528 EMEA)

12. Ethicon, PRC078105 Distal Tip Movement Claims Testing, November 2016, Data on File (114093-190513 EMEA)

13. Ethicon, PRC078173 Reduced Force to Fire Claims Study, November 2016, Data on File (115898-190605 EMEA)

14. Ethicon, Summary of Design intent for ECHELON CIRCULAR Powered Stapler to support claims, November 2016, Data on File (115899-190605 EMEA)

© Ethicon Endo-Surgery (Europe) GmbH 2019, 123443-190914 EMEA

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