Johnson & Johnson Launches the ETHICON™ 4000 Stapler for Elevated Surgical Experience and the Most Secure Staple Line Yet1

The stapling system features ETHICON™ 3D Reloads with proprietary 3D Stapling Technology and enhanced Gripping Surface Technology to manage tissue complexities and reduced potential leaks and bleeds at the staple line^2I

New ETHICON advanced stapling technology to be harnessed for future use exclusively on the OTTAVA™ Robotic Surgical System

ETHICON 4000 Stapler and ETHICON™ 3D Reloads will be showcased at the American Society for Metabolic and Bariatric Surgery Annual Meeting on June 15-19, 2025

Johnson & Johnson MedTech, a global leader in surgical technologies and solutions, today announced the U.S. launch of the ETHICON™ 4000 Stapler, an advanced surgical stapler designed to manage tissue complexities and deliver exceptional staple line integrity to minimize risk factors for surgical leaks and bleeding complications across specialties.

With proprietary 3D Staple Technology, a redesigned end effector, and streamlined reload options for consistency from the first staple to the last to reduce potential leak pathways, the ETHICON™ 4000 and ETHICON™ 3D Reloads are approved for use in open and laparoscopic surgery today. The new advanced stapling technology and reloads are also planned for future use exclusively on the OTTAVA™ Robotic Surgical System. The company will showcase the ETHICON 4000 System alongside its comprehensive portfolio of surgical technologies at the American Society for Metabolic and Bariatric Surgery Annual Meeting taking place in Washington, DC, on June 15-19, 2025.

“We are building on a legacy of innovation and trusted performance in surgical instrumentation to offer new innovations that address some of the most common and costly surgical complications,” said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. “As surgeons work diligently to meet the changing needs of patients, surgical technology must adapt. Johnson & Johnson MedTech is responding by delivering innovation for consistent and reliable experiences across open, minimally invasive, and robotic surgery.”

Addressing surgical complications across specialties
When stapling is used during surgery to compress and fuse tissue together, thick, fragile, and inconsistent tissue create complex variables that can compromise the integrity of the staple line, which may result in leaks or bleeds. Complications in priority procedures are estimated to be nearly $3B in cost burden in the U.S. alone.³ About half of bariatric surgeons report taking extra steps to reduce complications from leaks and bleeding at the staple line,⁴ including using adjunctive hemostasis products, placing clips, or oversewing.

The ETHICON 4000 Stapler with ETHICON 3D Reloads elevates stapler performance to address common complications and reduced staple line interventions due to bleeding by 23% compared to traditional 2D staples.^5II

“The 3D Stapling Technology allows me to more evenly distribute pressure throughout the staple line with more consistency,” said, Kelvin D. Higa, MD, FACS, FASMBS, FIFSO, Clinical Professor of Surgery at the UCSF Fresno Medical Education Program, and VP, Chief Medical and Quality Officer at Fresno Heart and Surgical Hospital. “As a surgeon, these technological advancements featured on the ETHICON 4000 will give me greater peace of mind when navigating tissue complexities, even in my most complicated procedures. As Chief Medical and Quality Officer, it is essential we evaluate all devices in the context of safety and value for our organization.”

Surgical stapling technology backed by real-world evidence
Since 2017, the use of ETHICON™ Surgical Stapling devices has demonstrated an association with improved clinical and economic outcomes—across varied tissue types, patient populations and countries—in bariatric, thoracic, and colorectal procedures.^6-8

The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads build on this expertise to deliver staples with offset closure of the staple legs to more evenly distribute compression throughout the staple line,^8III improving staple line integrity,¹ leak resistance,⁹ and hemostasis.⁵ The redesigned stapler reload continues to feature enhanced Gripping Surface Technology (GST) that has been optimized to stabilize tissue and reduce tissue slippage.^10IV The new ETHICON advanced stapling technology, including the end-effector and reloads, are designed for future use exclusively on the OTTAVA Robotic Surgical System.

“When I am performing surgery, potential complications related to tissue variability are top of mind,” said Dr. Erik Wilson**, Chief of Minimally Invasive and Elective General Surgery UT Health Houston. “Consistency and reliability of performance across open, laparoscopic, and robotic surgery could address a significant unmet need in today’s OR.”

Showcasing technology for bariatric surgery
Johnson & Johnson MedTech will host several presentations, hands-on trainings, and live demonstrations of the ETHICON 4000 and its portfolio of broader surgical technologies to support bariatric procedures throughout the American Society for Metabolic and Bariatric Surgery Annual Meeting. Attendees can learn more by visiting Booth #1300 or online.

The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads, 60mm, received 510(k) clearance by the U.S. Food & Drug Administration earlier this year.

The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads will soon be commercially available in the U.S. with availability to select hospital sites in select markets forthcoming.

The OTTAVA™ Robotic Surgical System is under development and is not authorized to be marketed or sold in any market.

About Surgical Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. For over 100 years, we have helped advance surgical care through our innovative portfolio across wound closure, adjunctive hemostats, surgical stapling and instruments, robotics and digital solutions. Together, with clinicians and healthcare experts around the world we are progressing what’s next in surgery to better solve patient needs in metabolic and cardiovascular disease, cancer, and aesthetics and reconstruction.

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn. Ethicon, Inc. is part of Johnson & Johnson MedTech.

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 ETHICON™ 4000 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 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; 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 healthcare products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Footnotes
*Dr. Kelvin Higa is a paid consultant for Johnson & Johnson MedTech.

**Dr. Eric Wilson is a paid consultant for Johnson & Johnson MedTech.

^I. Evaluation of leakage pathways. ETHICON™ 3D Reload (ER60B) had less leak pathway area at 0.302 in² compared to ECHELON ENDOPATH™ GST Reload (GST60B) at 0.401 in².

^II. Based on retrospective comparative analysis of hemostasis performance in a porcine model comparing the proportion of transections requiring intervention for the ETHICON 4000 Stapler with 3D Reloads (EC3D60C & ER60W) vs. the ECHELON™ 3000 with GST Reloads (ECH60C & GST60W), n=114.

^III. Evaluation of leakage pathways. ETHICON™ 3D Reload (ER60B) had less leak pathway area at 0.302 in² compared to ECHELON ENDOPATH™ GST Reload (GST60B) at 0.401 in².

^IV. In benchtop testing in 4.0mm thick porcine stomach tissue, ETHICON™ 3D Reloads (ER60T) had less mean longitudinal change compared to ECHELON ENDOPATH™ GST Reloads (GST60T): 0.126 mm vs 0.202 mm, p less than 0.0.05.

References
^1. Johnson & Johnson and its affiliates. Ethicon™ 4000 with Ethicon™ 3D Reloads – Staple Performance Claims. February, 2024. Windchill # 502188145

^2. Johnson & Johnson and its affiliates. Evaluation of Leak Pathways for Claims: Echelon 4000 with 3D Reloads vs Echelon 3000 Stapler with GST. November 2024. Windchill # 502123426.

^3. Johnson & Johnson and its affiliates. Specialty Health Economic Market Access: Focus on Complication Outcomes to Improve Patient Care. 2018.

^4. Global Business Insights. Bariatric Hemostasis Segment Sizing Incidence and Key Learnings- U.S and EMEA. September 2019.

^5. ETHICON. Project Royal Retrospective Analysis: Hemostasis Performance Evaluation of Royal Stapler with Royal 3D 60 mm White Reload Compared to the ECHELON™ 3000 Stapler with 2D Gripping Surface Technology 60 mm White Reload in Non-Survival Swine Gastroepiploic Models. 1/23/2025. Windchill #PRE-24-0058.

^6. 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.

^7. 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.

^8. Sylla P, Sagar P, Johnston S, et al. Outcomes associated with the use of a new powered circular stapler for left-sided colorectal reconstructions: a propensity score matching-adjusted indirect comparison with manual circular staplers. Surgical Endoscopy. 2021. doi: 10.1007/s00464-021-08542-7.

^9. Johnson & Johnson and its affiliates. Evaluation of Staple Leak Performance for Claims: Ethicon™ 4000 with 3D Reloads, Echelon™ 3000 with GST Reloads, EndoGIA and Signia with Tri-Staple Technology. 2/25/2025. Windchill #502199429

^10. ETHICON. Evaluation of Stomach Tissue Movement During Stapler Firing for Claims: Project Royal. 2/17/2025. Windchill #502120216.

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

© Johnson & Johnson and its affiliates 2025. US_SRG_STAP_401829