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

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

Vienna (ots/PRNewswire) - 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

MEDIA CONTACTS
Chiara Antoniucci
Office: +39-06-9119-4064
cantoniu@its.jnj.com

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