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ETHICON ANNOUNCES LAUNCH OF NEXT GENERATION ECHELON™ 3000 STAPLER

02 July 2024

2^nd July 2024: Ethicon, The Surgical Technologies Company of Johnson & Johnson MedTech announces the launch of ECHELON™ 3000 Stapler, a digitally enabled device that provides surgeons with one-handed powered articulation to help address the unique needs of their patients.

Designed with 39% greater jaw aperture^A,1 and a 27% greater articulation.^B,1 The ECHELON™ 3000 Stapler can enable better access with the greatest left/right articulation span of leading handheld laparoscopic staplers.^C,1 It allows surgeons to position the jaws of the stapler where they want.^D,1,2 It can simultaneously cut and staple tissue across a variety of tissue types in both open and minimally invasive surgical procedures.³ One-handed, powered articulation with the ability to set the jaws to any point within the articulation span gives you more control when you need it most.^E,4

"Surgical complications often arise from difficult-to-access anatomy and compromised tissue, which this next generation ECHELON stapler is specifically designed to address,” commented Sandy Phillips, Business Unit Director Endo Mechanical and Energy, UK, at Johnson & Johnson MedTech. "Our aim, with ECHELON 3000, is to arm surgeons with a device that that helps address the root causes of surgical complications, enabling them to successfully navigate the differing needs of each patient’s anatomy, deliver on their preoperative plans and ultimately enhance patient outcomes.”

“Surgeons encounter challenges in accessing intricate anatomy and compromised tissue on a daily basis, resulting in potential surgical complications” commented Alison Wilson, Ethicon Lead, Ireland, at Johnson & Johnson MedTech. The Echelon 3000 stapler represents a revolutionary advancement in surgical stapling, tailored to specifically assist surgeons in effectively tackling these challenges. By doing so, it empowers surgeons to navigate each patient's unique anatomy with more precision, adhere to their perioperative plan, and ultimately elevate patient outcomes.

‘’The powered 55-degree articulation of the ECHELON 3000 allows for better access, especially in the tight thoracic cavity. The greater jaw aperture of the device allows you to transect the fissure effectively which could potentially save a reload during a case’’ said Mike Shackcloth,^F Thoracic Consultant & Head of Thoracic Research and Audits at Liverpool Heart & Chest.

“The Echelon 3000 is a completely new experience; it’s really easy to use and I appreciate that the design is not overly complex, and it is a reliable one-handed device. It has been a game changer for me and my practise for both VATs and open thoracic cases” said Julius Asante-Siaw,^F Thoracic Consultant, Clinical Lead and Head of Department at Liverpool Heart & Chest.

Staple Line Integrity
ECHELON 3000 builds upon the ECHELON™+ Stapler with GST Reloads, bringing forward the same capabilities in advancing staple line security to deliver fewer leakage pathways at the staple line, even in thick tissue.^G,5,6 While it can be used in a wide range of surgical procedures, it was designed to be used in thoracic, colorectal, and bariatric/gastric laparoscopic procedures³ where improvements in device access and control can make a meaningful difference.

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. Our 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 more information about the ECHELON 3000 stapler, visit: https://www.jnjmedtech.com/en-GB/product/echelon-3000-stapler

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 Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding Johnson & Johnson MedTech UK. 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 Johnson & Johnson Medical Limited 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 January 1, 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 Johnson & Johnson Medical Limited nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.

Footnotes:
A.    Comparison of average jaw aperture for ECHELON™ 3000 Stapler 60mm (22.79mm) vs. Medtronic Signia™ Stapling System 60mm (16.38mm), p< 0.001
B.    Comparison of average maximum articulation angle for ECHELON™ 3000 60mm Stapler (56.51°) vs. Medtronic Signia™ Stapling System 60mm (44.56°), p<0.05
C.    Comparison of average maximum articulation angle for ECHELON™ 3000 60mm Stapler (56.51°) and ECHELON™ 3000 45mm Stapler (56.95°) vs. leading competitors: Medtronic Signia™ Stapling System 60mm (44.56°), Medtronic Signia™ Stapling System 45mm (45.87°), ECHELON™+ Stapler 60mm (43.87°), ECHELON™+ Stapler 45mm (43.92°), p<0.001.
D.    The average maximum articulation angle of ECHELON™ 3000 60mm Stapler (56.51°) and ECHELON™ 3000 45mm Stapler (56.95°) with the ability to move the jaws in 1° increments.
E.    Compared to the legacy Powered Plus Stapler
F.    Mike Shackcloth and Julius Asante-Siaw have not been compensated for their testimonials.
G.    Advancing staple line security with fewer leakage pathways and less malformed staples. Fewer leakage pathways: benchtop testing in porcine tissue ≤ 30mmHg (26mmHG average pressure experienced during typical leak test), comparing Ethicon ECHELON+ Stapler PSEE60A with GST Reloads GST60B to Medtronic Signia™ and Endo GIA™ Staplers with Tri-Staple™ Reloads EGIA60AMT. Cumulative number of leaked tests (0/30), (7/30) & (9/30) respectively, n=30, p<0.05. Fewer malformed staples: benchtop testing in 3.3mm and 4.0mm porcine tissue comparing malformed staples between ECHELON+ Stapler with GST Reloads (GST60G, GST60T) to Medtronic Signia™ Stapler with Tri-Staple™ Reloads (EGIA60AMT, SIG60AXT) and Endo GIA™ with Tri-Staple™ Reloads (EGIA60AMT, EGIA60AXT). Percentage malformed results: 1.14% vs 4.28%, p<0.05. Based on benchtop testing and clinical effect is unknown.

References:

Ethicon Jaw Aperture and Articulation Angle Measurement: Echelon™ 3000 Stapler with GST vs EndoGIA and Signia with Tri-Staple Technology, A.6. 01/10/2022. Windchill #500657863 (EM_ETH_STAP_302287, EM_ETH_STAP_302290, EM_ETH_STAP_304790, EM_ETH_STAP_302018)
Ethicon Echelon 3000 (McLaren) EP1.1 Sub-Completion Report - Functional Characteristic Tests,
B.2. 10/13/2021. Windchill Document #500675279 (EM_ETH_STAP_302018)
ECHELON™ 3000 Stapler Instructions for Use.
Ethicon Memorandum for Echelon™ 3000 Devices Design Claims 2022, A.3. 02/14/2022. Windchill Document #500884201 (EM_ETH_STAP_303559)
Ethicon Ex-Vivo Comparison of Staple Line Leak Pressure: Echelon Flex Powered Plus Stapler with GST vs EndoGIA and Signia with Tri-Staple Technology, A.1. 08_13_2020. Windchill Document #PRC096436 (EM_ETH_STAP_223261)
Ethicon Evaluation of Malformed Staples in Thick Tissue for Claims: Echelon Flex Powered Plus Stapler with GST vs EndoGIA and Signia with Tri-Staple Technology, A.1. 08_25_2020. Windchill Document #PRC096858 (EM_ETH_STAP_223261)

Please refer always to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.

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Johnson & Johnson Medical Limited Baird House, 4 Lower Gilmore Bank, Edinburgh, EH3 9QP.
www.jnjmedtech.com

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