New intelligent stapling system provides real-time tissue feedback

新型智能钉合系统提供实时组织反馈

to standardize performance

标准化性能

Medtronic plc , a global leader in healthcare technology, has today announced the limited launch of the Signia™ Circular Stapler with Tri-Staple™ technology. The new system gives surgeons the first intelligent circular stapling option throughout the alimentary tract for the creation of end-to-end, end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

全球医疗技术领导者美敦力公司今天宣布有限推出带有Tri-Staple技术的Signia™圆形吻合器。该新系统为外科医生提供了在整个消化道中首个智能圆形吻合选择，用于在开放手术和腹腔镜手术中创建端对端、端对侧以及侧对侧的吻合。

It combines powered and intelligent clamping with improved perfusion of the staple line,.

它结合了动力夹持和智能夹持，并改善了缝合线的灌注。

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as well as reducing stress on tissue during compression and clamping.

以及在压缩和夹紧过程中减轻组织的压力。

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The Signia Circular Stapler has also received regulatory market authorization in major markets globally, including the United States, Western Europe and Japan.

Signia圆形吻合器也已在包括美国、西欧和日本在内的全球主要市场获得了监管市场授权。

With over 6,000 staplers used in ORs across the US every day, Signia™ stapler brings intelligence to one of the most important parts of surgery. Circular staplers are commonly used in colorectal resection surgery, a procedure that is standard treatment for colon cancer and the main treatment for rectal cancer.

在美国，每天有超过6000台吻合器在手术室中使用，Signia™吻合器为手术中最重要的环节之一带来了智能化。圆形吻合器常用于结直肠切除术，这是结肠癌的标准治疗方法，也是直肠癌的主要治疗手段。

When the two ends of the colon are not sealed properly, an anastomotic leak can occur, and gastrointestinal contents of the gut can leak out of the wound site, increasing the risk of a serious infection. Anastomotic leaks can occur in up to 19% of these procedures..

当结肠的两端没有正确密封时，可能会发生吻合口漏，肠道内容物可能从伤口处泄漏，增加严重感染的风险。在这些手术中，吻合口漏的发生率可高达19%。

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The Signia™ Circular stapler is the only circular stapler in the market that allows for integrated leak testing and provides greater leak reduction.

Signia™圆形吻合器是市场上唯一一款允许进行集成漏气测试并提供更大程度减少漏气的圆形吻合器。

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Other differentiated features include:

其他差异化特性包括：

Up to 53% less distal tip motion during clamping and firing.

在夹紧和发射过程中，远端尖端运动减少多达53%。

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88% reduction in waste per procedure thanks to its universal, reusable handle.

每次操作产生的废弃物减少88%，这要归功于其通用、可重复使用的手柄。

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'The Signia™ Circular stapler brings a new level of precision and confidence to the OR,'

“Signia™圆形吻合器为手术室带来了更高水平的精确性和信心，”

said Krista Sugerman, vice president & general manager, Core Surgical Innovations, which is part of the Medtronic Medical Surgical Portfolio.

克莉丝塔·苏格曼（Krista Sugerman）说道，她是美敦力医疗外科产品组合中核心外科创新部门的副总裁兼总经理。

'This technology helps standardize performance, improve efficiency, reduce variation, and ultimately supports better patient outcomes. It’s also a vital step toward building a complete and connected OR, where intelligent instruments work together across digital and robotics platforms to support improved patient outcomes.”.

“该技术有助于规范性能、提高效率、减少差异，最终支持更好的患者治疗效果。这也是打造完整且互联的手术室的重要一步，智能仪器在数字化和机器人平台之间协同工作，以支持改善患者的治疗效果。”

The Signia™ Circular stapler integrates the Medtronic

Signia™圆形吻合器集成了美敦力的技术

Tri-Staple™

三重吻合器™

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和

Adaptive Compression™

自适应压缩™

technologies to monitor and adjust the amount of compression that is being applied, which may prevent the user from over-compressing and damaging tissue

技术可以监控和调整施加的压缩量，这可能会防止用户过度压缩并损伤组织。

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. Less tissue compression from the powered intelligence of the Signia™ Circular stapler can reduce hematoma formation by as much as 80%

Signia™圆形吻合器的电动智能可减少组织压迫，从而将血肿形成减少多达80%。

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. It also has been shown to provide up to 164% improved perfusion into the staple line.*

. 它还被证明可使钉合线的灌注提高达164%。*

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“We are excited to bring the Tri-Staple™ technology that many surgeons have come to rely on in our Signia™ linear staplers to procedures that require circular staplers, such as colorectal resection,”

“我们很高兴将许多外科医生在Signia™线性吻合器中依赖的Tri-Staple™技术应用到需要圆形吻合器的手术中，例如结直肠切除术。”

said Dr Matthew Kroh, chief medical officer, Core Surgical Innovations at Medtronic

美敦力核心外科创新部门首席医疗官马修·克罗博士表示

. “With superior performance, intelligent feedback, and a unique set of features that enable greater perfusion and more protection against leaks, surgeons can now rely on the Signia™ circular stapler to deliver a confident staple line.”

“凭借卓越的性能、智能反馈以及一套独特的功能，Signia™圆形吻合器能够实现更佳的灌注效果和更好的防漏保护，外科医生现在可以依靠它来提供令人放心的缝合线。”

Full product availability is anticipated in early summer 2026. For more information, visit the Signia™

预计产品将在2026年夏初全面上市。欲了解更多信息，请访问Signia™。

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Notes to editors:

编辑须知：

*Preclinical results may not correlate with clinical performance in humans. Based on leak testing in an in vivo canine model comparing Signia™ Circular stapler (SIGCIR25XT) to ECHELON CIRCULAR™ Powered stapler (CDH25P) (n = 9; p = 0.007).

*临床前结果可能与人体临床表现无相关性。基于在体内犬模型中进行的泄漏测试，比较Signia™圆形吻合器（SIGCIR25XT）与ECHELON CIRCULAR™电动吻合器（CDH25P）（n = 9；p = 0.007）。

†The Signia™ circular stapler allows 164% greater perfusion into the staple line than the Echelon Circular™* powered stapler, which may facilitate better wound healing at the anastomotic site. Compared to the ECHELON Circular™* powered stapler in an in vivo benchtop comparison (CDH31P: n = 13; SIGCIR31XT: n = 9, p = 0.043).

†Signia™圆形吻合器比Echelon Circular™*电动吻合器在吻合线处的灌注量高出164%，这可能有助于吻合部位更好的伤口愈合。与ECHELON Circular™*电动吻合器在体内工作台对比中相比（CDH31P：n = 13；SIGCIR31XT：n = 9，p = 0.043）。

Results may not correlate with clinical performance in humans..

结果可能与人体临床表现无关。

††Based on simulated use by trained surgeons comparing CDH31P to SIGCIR31XT (n = 15, p < 0.001)

基于训练有素的外科医生模拟使用，比较CDH31P与SIGCIR31XT（n = 15，p < 0.001）

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Total waste based on device component weights and expected circulation ratio of each component on a per-procedure basis comparing CDH31P to the Signia™ circular stapler with a 31 mm Tri-Staple™ reload (n = 3, p < 0.001).

基于设备组件重量和每个组件在每次手术中的预期循环比例，比较CDH31P与Signia™圆形吻合器（配备31毫米Tri-Staple™ reload）的总废料量（n = 3，p < 0.001）。

About Medtronic

关于美敦力

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries.

大胆思考。更果敢的行动。我们是美敦力。美敦力公司总部位于爱尔兰戈尔韦，是全球领先的医疗技术公司，通过寻找并发现解决方案，大胆攻克人类面临的最棘手的健康问题。我们的使命——减轻病痛、恢复健康、延长生命——将遍布150多个国家的95,000多名充满热情的员工团结在一起。

Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

我们的技术和疗法治疗70种健康状况，包括心脏设备、手术机器人、胰岛素泵、手术工具、患者监测系统等。凭借我们多样化的知识、永无止境的好奇心和帮助所有需要帮助的人的愿望，我们提供了创新的技术，每秒、每小时、每一天都在改变两个人的生活。

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit .

期待我们带来更多精彩，因为我们致力于推动以洞察力为导向的护理、以人为本的体验，以及为我们的世界创造更好的成果。在我们所做的一切中，我们正在创造非凡的工程。如需更多关于美敦力的信息，请访问。

www.Medtronic.com

www.美敦力.com

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

任何前瞻性陈述均受风险和不确定性的影响，例如美敦力向证券交易委员会提交的定期报告中描述的那些。实际结果可能与预期结果有重大差异。

Contacts:

联系人：

Laura Moerman

劳拉·莫尔曼

Public Relations

公共关系

+32 476 228902

+32 476 228902

Ryan Weispfenning

瑞安·魏斯芬宁

Investor Relations

投资者关系

+1-612-839-4549

+1-612-839-4549

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Preclinical test results may not necessarily be indicative of clinical performance. Compared to the EEA™ circular stapler with DST Series™ technology in an in vivo benchtop comparison (EEA31: n = 15; SIGCIR31XT: n = 9, p = 0.045). OR Compared to the Ethicon Circular™* powered stapler in an in vivo benchtop comparison (CDH31P: n = 13; SIGCIR31XT: n = 9, p = 0.043)..

临床前测试结果不一定能反映临床表现。与具有DST Series™技术的EEA™圆形吻合器在体内工作台对比中相比（EEA31：n = 15；SIGCIR31XT：n = 9，p = 0.045）。或与Ethicon Circular™*电动吻合器在体内工作台对比中相比（CDH31P：n = 13；SIGCIR31XT：n = 9，p = 0.043）。

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Based on internal test report #RE00470656 rev.0, Comparative in vivo leak testing. July 2023

基于内部测试报告#RE00470656 rev.0，比较体内泄漏测试。2023年7月

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Based on internal test report #RE00330708 rev.1, PCG-42, Perfusion analysis for circular staplers. May 13, 2021.

基于内部测试报告#RE00330708 rev.1，PCG-42，圆形吻合器的灌注分析。2021年5月13日。

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Based on internal test report #RE00185349 rev.1, Tissue clamp benchmark vs. manual instruments (Tulip, DST™, & Ethicon™*). Nov 2023.

基于内部测试报告 #RE00185349 rev.1，组织钳基准测试对比手动工具（Tulip、DST™ 和 Ethicon™*）。2023年11月。

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Based on internal test report #RE00350454, Compression testing for powered CDH 29mm product. Sept. 13, 2021.

基于内部测试报告#RE00350454，对电动CDH 29mm产品进行压缩测试。2021年9月13日。

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Bench test results may not necessarily be indicative of clinical performance. Compared to EEA™ circular staplers with DST

台架试验结果不一定能反映临床性能。与带有DST的EEA™圆形吻合器相比

Series™ technology (EEA2835, p < 0.001, n = 5), Ethicon™ CDH (CDH29A n = 9 , p < 0.001, n = 5 for SIGCIR, for CDHA), and Ethicon Echelon Circular™* powered stapler (Ethicon™ CDH29P, p < 0.001, n = 5).

Series™ 技术（EEA2835，p < 0.001，n = 5），Ethicon™ CDH（CDH29A n = 9，p < 0.001，n = 5，适用于SIGCIR和CDHA），以及Ethicon Echelon Circular™* 电动吻合器（Ethicon™ CDH29P，p < 0.001，n = 5）。

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Tsalikidis C, Mitsala A, Mentonis VI, et al. Predictive Factors for Anastomotic Leakage Following Colorectal Cancer Surgery: Where Are We and Where Are We Going?. Curr Oncol. 2023;30(3):3111-3137. Published 2023 Mar 7. doi:10.3390/curroncol30030236

察里基迪斯 C，米察拉 A，门托尼斯 VI，等。结直肠癌手术后吻合口漏的预测因素：我们身在何处，又将去往何方？《当代肿瘤学》。2023；30（3）：3111-3137。发表于2023年3月7日。doi:10.3390/curroncol30030236

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[1]

[1]

Litchinko A, Buchs N, Balaphas A, et al. Score prediction of anastomotic leak in colorectal surgery: a systematic review. Surg Endosc. 2024;38(4):1723-1730. doi:10.1007/s00464-024-10705-1.

李钦科 A, 布赫斯 N, 巴拉法斯 A, 等。结直肠手术中吻合口漏的评分预测：一项系统综述。《外科内窥镜》。2024；38（4）：1723-1730。doi:10.1007/s00464-024-10705-1。

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Renna MS, Grzeda MT, Bailey J, et al. Intraoperative bowel perfusion assessment methods and their effects on anastomotic leak rates: meta-analysis. Br J Surg. 2023;110(9):1131-1142. doi:10.1093/bjs/znad154

雷纳 MS，格泽达 MT，贝利 J，等。术中肠道灌注评估方法及其对吻合口漏率的影响：荟萃分析。《英国外科杂志》。2023；110（9）：1131-1142。doi:10.1093/bjs/znad154

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Preclinical results may not correlate with clinical performance in humans. Based on leak testing in an in vivo canine model comparing Signia™ Circular Stapler to ECHELON CIRCULAR™ Powered Stapler (SIGCIR28MT: n=18; CDH29P, n = 14; p = 0.028).

临床前结果可能与人体临床表现不相关。基于在体内犬模型中进行的泄漏测试，比较了Signia™圆形吻合器与ECHELON CIRCULAR™电动吻合器（SIGCIR28MT：n=18；CDH29P，n=14；p=0.028）。

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Based on internal test report #RE00394109 rev. 0, Distal tip motion and user feedback for circular staplers: EEA™ with Tri-Staple™, Signia™ circular with Tri-Staple™, and Ethicon™* Echelon™* circular powered stapler. October 2023.

基于内部测试报告 #RE00394109 修订版 0，关于圆形吻合器的远端尖端运动及用户反馈：EEA™ with Tri-Staple™、Signia™ circular with Tri-Staple™ 和 Ethicon™* Echelon™* circular powered stapler。2023年10月。

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Based on internal test report #RE00421208 rev. 0, PCG-055: Per procedure waste. January 4, 2023.

基于内部测试报告 #RE00421208 修订版 0，PCG-055：按程序废弃。2023年1月4日。

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Compared to manual clamping circular staplers, p < 0.001, n= 5 for SIGCIR, n = 9 for TriEEA. Bench test results may not necessarily be indicative of clinical performance.

与手动夹紧圆形吻合器相比，p < 0.001，SIGCIR 的 n=5，TriEEA 的 n=9。台架测试结果不一定能反映临床性能。

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Based on internal test report #RE00394488, Hematoma analysis of Signia™ Circular and Ethicon Echelon™* Powered circular firings. Oct 2023

基于内部测试报告 #RE00394488，Signia™ 圆形和 Ethicon Echelon™* 动力圆形击发的血肿分析。2023年10月

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Preclinical results may not correlate with clinical performance in humans. Based on compression testing in an in vivo canine model comparing SIGCIR28XT (n=3) to CDH29P (n = 3), p = 0.007.

临床前结果可能与人体临床表现不相关。基于在体内犬模型中进行的压缩测试，比较SIGCIR28XT（n=3）与CDH29P（n=3），p=0.007。

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Blanco-Colino R, Espiin-Basany E. Intraoperative use of ICG fluourescence imaging to reduce the risk of anastomotic leakage in colorectal surgery: a systematic review and meta-analysis. Tech Coloproctol. 2018;22(1):15-23.

Blanco-Colino R，Espiin-Basany E。术中使用ICG荧光成像降低结直肠手术吻合口漏风险：系统评价与荟萃分析。《技术结直肠病学》。2018；22（1）：15-23。

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[1]

[1]

Smallwood N, Mutch MG, Fleshman JW. The failed anastomosis. In: Steele SR, Maykel JA, Champagne BJ, Oragnio Gr, eds. Complexities in Colorectal Surgery: Decision-Making and Management. New York, NY: Springer Science and Business Media; 2014:277-304.

Smallwood N，Mutch MG，Fleshman JW。《失败的吻合术》。载于：Steele SR，Maykel JA，Champagne BJ，Oragnio Gr 编，《结直肠外科的复杂性：决策与管理》。纽约，NY：Springer Science and Business Media；2014:277-304。

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Compared to the Ethicon Circular™* powered stapler in an in vivo benchtop comparison (CDH31P: n = 13; SIGCIR31XT: n =9, p = 0.043). Results may not correlate with clinical performance in humans.

与Ethicon Circular™*电动吻合器在体外台架对比（CDH31P：n = 13；SIGCIR31XT：n = 9，p = 0.043）。结果可能与人体临床表现无相关性。