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Johnson & Johnson MedTech, a global leader in surgical technologies and solutions, today announced that results from the TARGET study have been published by CHEST Journal. This landmark study demonstrated that clinicians were able to reach small and peripherally located lung nodules in more than 98% of cases with the MONARCH Platform and biopsy them with a safety profile comparable to non-robotic bronchoscopy techniques..
强生医疗科技公司(Johnson & Johnson MedTech)是外科技术与解决方案的全球领导者,今天宣布TARGET研究的结果已由《CHEST期刊》发表。这项具有里程碑意义的研究表明,在超过98%的病例中,临床医生能够利用MONARCH平台到达位于肺部深处的小结节,并以与非机器人支气管镜技术相当的安全性进行活检。
The TARGET (Transbronchial Biopsy Assisted by Robotic Guidance in the Evaluation of Tumors in the Lung) study followed 679 patients across 21 global sites in the U.S., Canada and Hong Kong as part of a single-arm prospective multicenter study. Patients were followed for at least one year.
TARGET(机器人引导辅助经支气管活检在肺部肿瘤评估中的应用)研究作为一项单臂前瞻性多中心研究的一部分,在美国、加拿大和香港的21个全球站点跟踪了679名患者。患者被随访至少一年。
The study, published on April 26, 2025, was designed to measure clinical safety, navigation success and diagnostic yield across a broad range of patients in a real-world setting. Investigators reported that the robotically-guided MONARCH bronchoscope reached the lesion in 98.7% of cases with a diagnostic yield of 83.2%* and a safety profile that is comparable to non-robotic bronchoscopy[i]..
该研究于2025年4月26日发布,旨在真实世界环境中针对广泛患者群体评估临床安全性、导航成功率和诊断率。研究人员报告称,机器人引导的MONARCH支气管镜在98.7%的病例中成功到达病灶,诊断率为83.2%*,其安全性与非机器人支气管镜相当[i]。
In addition to endpoints for safety, navigation success and diagnostic yield, investigators also noted learnings about variables found to be significantly associated with higher diagnostic yield, including history of chronic obstructive pulmonary disease (COPD)/emphysema and presence of a bronchus sign.
除了安全性、导航成功率和诊断率的终点指标外,研究人员还指出了关于与较高诊断率显著相关的变量的学习成果,包括慢性阻塞性肺疾病(COPD)/肺气肿病史和支气管征象的存在。
To build deeper understanding of robotic-assisted bronchoscopy, investigators are continuing to explore these areas, analyzing and reporting data related to patient stature/height, subsolid nodules, atypical cells and performance of biopsy tools in RAB, with results intended for presentation and publication..
为了更深入地了解机器人辅助支气管镜,研究人员正在继续探索这些领域,分析和报告与患者身高、亚实性结节、非典型细胞以及RAB中活检工具性能相关的数据,结果将用于展示和发表。
“Contributing to the body of evidence for emerging technology, especially as a non-university, community tertiary care hospital, is an important part of advancing healthcare, and I am proud to have been part of the TARGET study,” said Dr. Faisal Khan*, one of the TARGET study investigators and currently Medical Director, Interventional Pulmonary & Endoscopy, at Franciscan Hospital in Indianapolis, Indiana.
“为新兴技术的证据体系做出贡献,特别是作为一家非大学的社区三级护理医院,这是推进医疗保健的重要部分,我为能参与TARGET研究感到自豪,”TARGET研究的调查员之一,目前担任印第安纳州印第安纳波利斯市方济各会医院介入肺科与内窥镜医学主任的费萨尔·汗医生表示。
“The results of this important study can help raise awareness of robotic-assisted bronchoscopy as a safe, effective option for physicians to raise the standard of care for patients.”.
“这项重要研究的结果可以帮助提高人们对机器人辅助支气管镜检查的认识,作为一种安全、有效的选择,可以提高医生对患者的护理标准。”
This latest publication adds to a growing list of high-quality clinical research sponsored by Johnson & Johnson MedTech supporting Robotically-Assisted Bronchoscopy, including abstracts from TARGET data subsets recently published at the American Association of Thoracic Surgeons meeting in Seattle on May 2, 2025 as well as the Association of Thoracic Surgeons meeting held this month in San Francisco.
这一最新的出版物增加了由强生医疗科技公司赞助的高质量临床研究的数量,这些研究支持机器人辅助支气管镜技术,包括2025年5月2日在西雅图举行的美国胸外科协会会议上发布的TARGET数据子集的摘要,以及本月在旧金山举行的胸外科医师协会会议上的相关发布。
Additional TARGET subset abstracts are expected for submission at upcoming major medical conferences..
预计将在即将召开的主要医学会议上提交更多的 TARGET 子集摘要。
“Johnson & Johnson is committed to generating evidence that demonstrates the safety and efficacy of our products and advances innovation in areas with significant unmet needs,” said Dr. Ray Fryrear, Vice President of Scientific Affairs for Robotics and Digital at Johnson & Johnson MedTech. “As the pioneers in the field of robotic-assisted bronchoscopy, we are committed to evolving its potential to change the way clinicians diagnose and treat lung cancer.”.
“强生致力于生成证据,以证明我们产品的安全性和有效性,并推动在存在显著未满足需求的领域进行创新,”强生医疗科技机器人与数字科学事务副总裁雷·弗赖尔博士表示。“作为机器人辅助支气管镜领域的先驱,我们致力于挖掘其潜力,改变临床医生诊断和治疗肺癌的方式。”
Robotically-assisted bronchoscopy represents a small but fast-growing segment of lung biopsy procedures in the U.S. The MONARCH Platform, the first robotically assisted bronchoscopy system to market, provides minimally invasive access to and visualization of airways to help clinicians biopsy suspicious lung nodules.
机器人辅助支气管镜检查是美国肺活检手术中一个规模较小但快速增长的领域。MONARCH平台是首个上市的机器人辅助支气管镜系统,提供微创进入和可视化气道的方式,帮助临床医生对可疑的肺结节进行活检。
Advances in RAB are important because nearly half of early-stage lesions are located in the periphery of the lung, which is difficult to reach with traditional bronchoscopy[ii]. The MONARCH Platform can aid clinicians in getting to an early, definitive diagnosis in lung cancer cases, which can help care teams get patients into the treatment pathway an average of three weeks faster[iii]..
RAB 的进步非常重要,因为近一半的早期病灶位于肺部外围,传统支气管镜难以到达[ii]。MONARCH 平台可以帮助临床医生在肺癌病例中获得早期、明确的诊断,有助于医疗团队让患者平均提前三周进入治疗路径[iii]。
Additional information about the study and results can be found on the CHEST Journal website: https://journal.chestnet.org/article/S0012-3692(25)00548-3/fulltext.
有关该研究和结果的更多信息,请访问《胸部》期刊网站:https://journal.chestnet.org/article/S0012-3692(25)00548-3/fulltext。
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最普遍的健康挑战。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方面的创新产品组合,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. For more, visit https://www.jnjmedtech.com/en-US/product-family/monarch..
我们与全球的临床医生和医疗保健专家共同努力,推动外科手术的未来发展,以更好地满足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。欲了解更多信息,请访问 https://www.jnjmedtech.com/en-US/product-family/monarch。
About Johnson & Johnson
关于约翰逊 & 约翰逊
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,治疗方法更加智能且侵入性更小,解决方案也更加个性化。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,提供明日的突破性成果,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 https://x.com/JNJMedTechand on LinkedIn. Auris Health, 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Twitter:https://x.com/JNJMedTech 和领英。Auris Health, Inc. 是强生医疗技术公司的一部分。
Indications for Use (United States)
使用指征(美国)
The MONARCH™ Bronchoscope and the MONARCH™ Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. Important Safety Information Complications from bronchoscopy may include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting, dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or an allergic reaction to medications.
MONARCH™ 支气管镜和 MONARCH™ 平台及其配件旨在为诊断和治疗程序提供支气管镜可视化及患者气道的访问途径。重要安全信息:支气管镜检查可能引起的并发症包括呼吸困难、声带痉挛、声音嘶哑、轻微发热、呕吐、头晕、支气管痉挛、感染、血氧水平低、活检部位出血或对药物的过敏反应。
More serious complications from bronchoscopy may include collapsed lung, respiratory failure, hemorrhage, burns, heart attack, or cardiac arrhythmia..
支气管镜检查更严重的并发症可能包括肺塌陷、呼吸衰竭、出血、烧伤、心脏病发作或心律失常。
For more, visit https://www.jnjmedtech.com/en-US/product-family/monarch
欲了解更多信息,请访问 https://www.jnjmedtech.com/en-US/product-family/monarch
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 MONARCH’s TARGET study. 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.
本新闻稿包含根据 1995 年《私人证券诉讼改革法案》定义的关于 MONARCH 的 TARGET 研究的“前瞻性声明”。读者请注意,不要过度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。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。
Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; 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 health care products and services; and trends toward health care cost containment.
风险和不确定性包括但不限于:商业成功的不确定性;专利挑战;竞争,包括技术进步、竞争对手获得的新产品和专利;生产困难和延误;产品功效或安全隐患导致的产品召回或监管行动;适用法律法规的变更,包括全球医疗保健改革;医疗卫生产品和服务购买者的行为和支出模式的变化;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可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声明”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 和其他提交给证券交易委员会的文件。
Copies of these filings are available online at www.sec.gov, 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.sec.gov、www.jnj.com获取,或应要求从Johnson & Johnson处获取。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. Khan is a paid consultant for Johnson & Johnson MedTech.
*Dr. Khan 是 Johnson & Johnson MedTech 的付费顾问。
Murgu S, Chen AC, Gilbert CR, Sterman DH, Pederson D, Rafeq S, Laxmanan B, Schwiers ML, Connelly J, Benz HL, Yasufuku K, Silvestri GA, for the TARGET Investigators, A Prospective, Multicenter Evaluation of Safety and Diagnostic Outcomes with Robotic-Assisted Bronchoscopy: Results of the Transbronchial Biopsy.
Murgu S、Chen AC、Gilbert CR、Sterman DH、Pederson D、Rafeq S、Laxmanan B、Schwiers ML、Connelly J、Benz HL、Yasufuku K、Silvestri GA,TARGET研究者团队,机器人辅助支气管镜的安全性和诊断结果的前瞻性多中心评估:经支气管活检结果。
Assisted by Robot Guidance in the Evaluation of Tumors of the Lung (TARGET) Trial, CHEST (2025), doi: https://doi.org/10.1016/j.chest.2025.04.022
在机器人引导辅助下进行肺部肿瘤评估(TARGET)试验,《胸部》(2025),doi: https://doi.org/10.1016/j.chest.2025.04.022
Murgu S, Sterman D, Yasufuku K. Demographic and lesion characteristics in the first 443 subjects enrolled in a multicenter observational real-world robotic bronchoscopy study: interim results from TARGET. Poster presented at: American Association for Bronchology and Interventional Pulmonology 2022 Annual Conference; August 11-13, 2022; Nashville, TN.
Murgu S, Sterman D, Yasufuku K. 在多中心观察性真实世界机器人支气管镜研究中,前443名受试者的 demographics 和病灶特征:TARGET 的中期结果。海报展示于:2022年美国支气管学与介入肺病学协会年度会议;2022年8月11日至13日;田纳西州纳什维尔。
Ost DE, Maldonado F, Shafrin J, et al. Quantifying the economic value of improvements in diagnostic accuracy of advanced bronchoscopy procedures. Am J Respir Crit Care Med. 2023;207:A4460
Ost DE, Maldonado F, Shafrin J, 等。量化高级支气管镜检查程序诊断准确性改进的经济价值。《美国呼吸与重症医学杂志》。2023年;207:A4460
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Lindsey Diaz-MacInnis
林赛·迪亚兹-麦克伊尼斯
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Source: jnj.com
来源:jnj.com