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..

强生医疗科技公司，作为外科技术和解决方案的全球领导者，今天宣布在美国推出ETHICON™ 4000吻合器，这款先进的外科吻合器旨在处理组织复杂性，并提供卓越的钉合线完整性，以减少跨专科手术泄漏和出血并发症的风险因素。

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.

凭借专有的3D钉合技术、重新设计的末端执行器以及简化的钉仓选项，ETHICON™ 4000和ETHICON™ 3D钉仓能够在从第一个钉到最后一个钉之间保持一致性，从而减少潜在的泄漏路径。这些产品现已获批用于开放手术和腹腔镜手术。这项全新的先进钉合技术及钉仓还计划未来专用于OTTAVA™机器人手术系统。

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..

该公司将在2025年6月15日至19日于华盛顿特区举行的美国代谢与肥胖手术学会年会上，展示ETHICON 4000系统及其全面的外科技术产品组合。

“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.

“我们正在建立一个在手术器械方面创新和值得信赖的性能遗产，以提供解决一些最常见和最昂贵的手术并发症的新创新，”强生医疗科技公司手术部门集团主席哈尼·阿布哈拉卡说。“随着外科医生努力满足患者不断变化的需求，手术技术也必须适应。

Johnson & Johnson MedTech is responding by delivering innovation for consistent and reliable experiences across open, minimally invasive, and robotic surgery.”.

强生医疗科技通过提供创新技术来应对这一挑战，确保在开放手术、微创手术和机器人手术中实现一致且可靠的体验。"

Addressing surgical complications across specialties

跨专业处理手术并发症

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.

在手术中使用缝合器来压缩和融合组织时，厚的、脆弱的以及不均匀的组织会产生复杂的变量，这些变量可能会破坏缝合线的完整性，从而导致泄漏或出血。在美国，优先级手术中的并发症估计会造成近 30 亿美元的成本负担。

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..

单独3。大约一半的减重外科医生报告说，他们会采取额外的措施来减少因缝合线漏气和出血引起的并发症4，包括使用辅助止血产品、放置夹子或进行覆盖缝合。

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

ETHICON 4000吻合器配合ETHICON 3D钉仓，相较于传统的2D吻合钉，可将吻合器性能提升至新高度，能够解决常见并发症，并将因出血导致的钉线干预减少23%。

“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.

“3D订书技术让我能够更均匀地在整个订书线上分布压力，且具有一致性，”加州大学旧金山分校弗雷斯诺医学教育项目的外科学临床教授、弗雷斯诺心脏和外科医院副总裁、首席医疗和质量官Kelvin D. Higa博士说道。

“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.”.

“作为一名外科医生，ETHICON 4000 上的这些技术进步将让我在处理组织复杂性时更加安心，即使是在我最复杂的手术中。作为首席医疗和质量官，我们必须从安全性和对我们机构的价值角度评估所有设备，这是至关重要的。”

Surgical stapling technology backed by real-world evidence

受现实世界证据支持的外科吻合技术

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

自 2017 年以来，在减重、胸腔和结直肠手术中，使用 ETHICON™ 外科吻合器械已显示出与改善临床和经济结果的关联——跨越不同的组织类型、患者群体和国家。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..

ETHICON™ 4000吻合器和ETHICON™ 3D钉仓基于这一专业知识，通过偏移钉腿的闭合方式来更均匀地分布整个钉线的压缩力，从而提升钉线的完整性、抗漏性能以及止血效果。重新设计的吻合器钉仓继续采用了增强的抓握表面技术（GST），该技术经过优化以稳定组织并减少组织滑动。全新的ETHICON先进吻合技术，包括末端执行器和钉仓，专为未来在OTTAVA机器人手术系统上的独家使用而设计。

“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.”.

“当我进行手术时，与组织变异性相关的潜在并发症是我最关心的问题，”德克萨斯大学健康休斯顿分校微创和选择性普通外科主任埃里克·威尔逊博士说。“在开放手术、腹腔镜手术和机器人手术中，性能的一致性和可靠性可以满足当今手术室中一个重要的未满足需求。”

Showcasing technology for bariatric surgery

展示减肥手术技术

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..

强生医疗科技将在美国代谢与肥胖手术协会年会期间举办多场演讲、实践培训，并现场演示ETHICON 4000及其广泛的外科技术产品组合，以支持减重手术的开展。参会者可通过访问展位#1300或在线方式了解更多信息。

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

今年早些时候，ETHICON™ 4000吻合器和ETHICON™ 3D 60mm钉仓获得了美国食品药品监督管理局（FDA）的510(k)许可。

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.

ETHICON™ 4000吻合器和ETHICON™ 3D弹匣即将在美国上市，未来将在部分市场的特定医院提供。

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

OTTAVA™ 机器人手术系统正在开发中，尚未被授权在任何市场进行营销或销售。

About Surgical Solutions from Johnson & Johnson MedTech

关于强生医疗科技的外科解决方案

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.

在强生公司，我们正在应对世界上最复杂和普遍的健康挑战。一百多年来，我们通过在伤口闭合、辅助止血剂、外科缝合、器械、机器人和数字解决方案领域的创新产品组合，推动了外科护理的进步。

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..

我们与全球的临床医生和医疗专家共同努力，推动外科手术的未来发展，以更好地解决患者在代谢和心血管疾病、癌症以及美学和重建方面的需求。

About Johnson & Johnson

关于强生公司

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.

在强生，我们相信健康就是一切。我们在医疗保健创新方面的优势使我们能够构建一个世界，在这个世界中，复杂疾病得以预防、治疗和治愈，治疗方法更智能、更少侵入性，并且解决方案更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们有能力在当今整个医疗保健解决方案领域进行创新，以实现明天的突破，并对人类健康产生深远影响。

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..

了解我们的医疗技术领域在全球范围内的规模以及在心血管、骨科、外科和视力解决方案方面的深厚专业知识，请访问 https://thenext.jnjmedtech.com。关注我们的LinkedIn和@JNJMedTech。Ethicon, Inc. 是强生医疗科技的一部分。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

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.

本新闻稿包含《1995年私人证券诉讼改革法案》中定义的关于ETHICON™ 4000吻合器的“前瞻性声明”。读者应注意不要依赖这些前瞻性声明。这些声明基于对未来事件的当前预期。

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.

如果基本假设被证明不准确，或已知或未知的风险或不确定性成为现实，实际结果可能与强生公司的预期和预测大相径庭。风险和不确定性包括但不限于：监管审批的不确定性；商业成功的不确定性；专利面临的挑战；竞争，包括技术进步、竞争对手推出的新产品和获得的专利；产品功效或安全性问题导致的产品召回或监管行动；适用法律法规的变更，包括全球医疗改革；医疗产品和服务购买者的行为及支出模式的变化；以及控制医疗成本的趋势。

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.

这些风险、不确定性和其他因素的进一步列表和描述，请参见强生公司最近的年度报告 Form 10-K，包括标题为“关于前瞻性陈述的警示说明”和“项目1A. 风险因素”的部分，以及强生公司随后的季度报告 Form 10-Q 和提交给证券交易委员会的其他文件。

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..

这些文件的副本可在网上 www.jnj.com 获取，或应要求从 Johnson & Johnson 获取。Johnson & Johnson 不承担因新信息、未来事件或发展而更新任何前瞻性声明的责任。

Footnotes

脚注

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

凯文·希加博士是强生医疗科技公司的付费顾问。

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

Eric Wilson博士是强生医疗科技的付费顾问。

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.

泄漏路径的评估。ETHICON™ 3D Reload（ER60B）的泄漏路径面积为0.302平方英寸，比ECHELON ENDOPATH™ GST Reload（GST60B）的0.401平方英寸更小。

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.

基于对猪模型中止血性能的回顾性比较分析，比较了需要干预的横断比例，使用ETHICON 4000吻合器与3D Reloads（EC3D60C和ER60W）对比ECHELON™ 3000与GST Reloads（ECH60C和GST60W），n=114。

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.

泄漏路径的评估。ETHICON™ 3D Reload（ER60B）的泄漏路径面积为0.302平方英寸，比ECHELON ENDOPATH™ GST Reload（GST60B）的0.401平方英寸更小。

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<0.0.05.

在4.0毫米厚的猪胃组织台架测试中，ETHICON™ 3D Reloads（ER60T）与ECHELON ENDOPATH™ GST Reloads（GST60T）相比，平均纵向变化较小：0.126毫米 vs 0.202毫米，p<0.05。

References

参考文献

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

强生公司及其关联公司。Ethicon™ 4000 使用 Ethicon™ 3D 再装钉仓 - 吻合器性能声明。2024年2月。Windchill 编号 # 502188145

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.

强生公司及其附属机构。泄漏路径索赔评估：Echelon 4000 使用 3D Reloads 与 Echelon 3000 吻合器使用 GST。2024年11月。Windchill 编号 502123426。

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

强生公司及其附属机构。特殊健康经济市场准入：关注并发症结果以改善患者护理。2018年。

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

全球商业洞察。减肥止血细分市场规模、发病率及关键经验——美国和欧洲、中东、非洲。2019年9月。

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..

ETHICON. 皇家项目回顾性分析：在非存活猪胃网膜模型中，比较皇家吻合器搭配皇家3D 60毫米白色钉仓与ECHELON™ 3000吻合器搭配2D抓握面技术60毫米白色钉仓的止血性能评估。2025年1月23日。Windchill编号 #PRE-24-0058。

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米勒 DL，罗伊 S，卡西斯 ES，等。电动和组织特异性内镜吻合技术对电视辅助胸腔镜手术肺叶切除术临床与经济结果的影响：一项回顾性、观察性研究。《先进治疗》。2018年4月16日。doi: 10.1007/s12325-018-0679-z。

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Sylla P, Sagar P, Johnston S, 等。使用新型电动圆形吻合器进行左侧结直肠重建的相关结果：与手动圆形吻合器的倾向评分匹配调整间接比较。《外科内镜学》。2021年。doi: 10.1007/s00464-021-08542-7。

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强生公司及其附属公司。吻合器泄漏性能声明评估：Ethicon™ 4000 使用 3D 再装钉仓，Echelon™ 3000 使用 GST 再装钉仓，EndoGIA 和 Signia 使用 Tri-Staple 技术。2025年2月25日。Windchill #502199429

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

有关完整的适应症、禁忌症、警告、注意事项和不良反应，请参阅完整包装说明书。

© Johnson & Johnson and its affiliates 2025. US_SRG_STAP_401829

© 强生公司及其关联公司 2025。US_SRG_STAP_401829

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