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Medtronic plc, a global leader in healthcare technology, today announced the first commercial use of the Liberant™ thrombectomy system (Liberant). Indicated for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems, Liberant expands the Medtronic portfolio of treatment options for peripheral arterial and venous diseases to include mechanical aspiration thrombectomy..
美敦力公司(Medtronic plc),全球医疗技术领域的领导者,今日宣布Liberant™血栓切除系统(Liberant)的首次商业应用。该系统适用于从外周动脉和静脉系统的血管中移除新鲜、柔软的栓子或血栓,Liberant扩展了美敦力针对外周动脉和静脉疾病的治疗方案组合,新增了机械抽吸血栓切除技术。
The first procedure using the Liberant thrombectomy system was performed by Ajit Rao, MD, vascular surgeon, The Mount Sinai Hospital, in New York on Nov. 21. “The Liberant thrombectomy system is an effective new tool that performs well even in complex cases, maneuvering through challenging anatomy with ease and limiting blood loss through an intelligent algorithm,” said Dr.
11月21日,纽约西奈山医院的血管外科医生阿吉特·拉奥博士首次使用Liberant血栓切除系统进行了手术。拉奥博士表示:“Liberant血栓切除系统是一个有效的新型工具,即使在复杂病例中也表现出色,能够轻松通过具有挑战性的解剖结构,并通过智能算法减少失血。”
Rao. “We’re able to remove clot burden with greater precision and, for patients, this means a procedure designed to be more efficient and aimed at helping them restore circulation and mobility as safely and effectively as possible.'.
饶。“我们能够以更高的精确度去除血栓,对患者而言,这意味着手术会更加高效,旨在尽可能安全有效地帮助他们恢复血液循环和活动能力。”
The Liberant platform leverages an intelligent algorithm that automatically adapts the pulse rate to provide appropriate aspiration power and pairs it with key advancements in catheter technology and blood conservation. Product features include:
Liberant平台利用智能算法,自动调整脉冲速率以提供适当的抽吸力,并将其与导管技术和血液保护的关键进步相结合。产品特点包括:
Availability in three sizes (6 French, 8 French [short and long lengths], and 12 French), providing physicians the flexibility to treat arterial, venous and arteriovenous vessels. Smaller and larger sizes are in development, with a 5 French rapid exchange catheter expected early calendar year 2026.
提供三种尺寸(6 French、8 French [短型和长型] 和 12 French),使医生能够灵活治疗动脉、静脉和动静脉血管。更小和更大的尺寸正在开发中,预计2026年初将推出5 French快速交换导管。
Catheters with an atraumatic and angled tip
带有无创且成角度尖端的导管
‡
‡
for more effective
为了更有效
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, wall-to-wall clot removal
,全覆盖的血栓清除
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and a hybrid braid-coil design that improves torque response.
混合编织-线圈设计,提高了扭矩响应。
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An ultrasonic sensor that directly measures blood flow and an intelligent algorithm that automatically adapts the pulse rate to provide appropriate aspiration power, resulting in 35% less blood loss compared to Penumbra Indigo™* Lightning in bench testing with ovine blood.
一种直接测量血流的超声波传感器和一种智能算法,该算法自动调节脉冲频率以提供适当的抽吸力,在使用绵羊血液进行的台架试验中,与Penumbra Indigo™* Lightning相比,失血量减少了35%。
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A catheter, dilator and clotbuster included in each set to deliver more value to physicians.
每套装置包含一根导管、一个扩张器和一个血栓清除器,为医生提供更大的价值。
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Compatibility with Excipio™* thrombectomy devices, rapid exchange catheters with a mechanical basket, used with controlled aspiration for procedural efficiency.
与Excipio™*血栓切除装置兼容,带有机械篮的快速交换导管,结合可控抽吸以提高手术效率。
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Excipio devices are purpose-built to work with aspiration catheters like the Liberant™ thrombectomy system.
Excipio 设备专为与抽吸导管(如 Liberant™ 血栓切除系统)配合使用而设计。
“Liberant is designed to provide precision catheter deliverability while minimizing blood loss during clot removal — two key challenges often faced in thrombectomy procedures,” said John Laird, MD, chief medical officer, Peripheral Vascular Health, which is a part of the Cardiovascular Portfolio at Medtronic.“ Additionally, Liberant’s compatibility with Excipio devices gives physicians the ability to combine aspiration and clot disruption technologies in particularly challenging cases.”.
“Liberant旨在提供精确的导管输送能力,同时在血栓清除过程中尽量减少血液流失——这是血栓切除术中经常面临的两个关键挑战,”美敦力心血管产品组合中周围血管健康部门的首席医疗官约翰·莱尔德(John Laird)博士说道。“此外,Liberant与Excipio设备的兼容性使医生能够在特别具有挑战性的病例中结合抽吸和血栓破碎技术。”
The launch of Liberant is the first milestone in a series of broader investments in peripheral and venous thrombectomy solutions by Medtronic. This includes pipeline investments as well as the initiation of a multicenter, real-world clinical assessment to evaluate the periprocedural device performance of both Liberant and Excipio. .
Liberant的推出是美敦力在周围和静脉血栓切除术解决方案方面一系列更广泛投资的第一个里程碑。这包括管道投资,以及启动了一项多中心、真实世界的临床评估,以评估Liberant和Excipio的围手术期设备性能。
Liberant and Excipio have U.S. Food and Drug Administration clearance and are currently available in the United States.
Liberant 和 Excipio 已获得美国食品和药物管理局的批准,目前在美国有售。
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Risks include, but are not limited to, embolization, hemorrhage, thrombosis, and vessel damage.
风险包括但不限于栓塞、出血、血栓形成和血管损伤。
References
参考文献
† Based on bench data with Liberant 8F long and 12Fr in standard mode compared to Penumbra Indigo™* Lightning 7Fr and 12Fr.
† 基于使用Liberant 8F长型和12Fr在标准模式下的实验数据,与Penumbra Indigo™* Lightning 7Fr和12Fr进行比较。
‡ On 8Fr and 12Fr.
‡ 适用于8Fr和12Fr。
§ Based on bench data measuring maneuverability
基于测量机动性的基准数据
◊ Based on bench data with Liberant 8Fr and 12Fr compared to Penumbra Lightning 7Fr and Lightning 12Fr. Torque response at 180 degrees
◊ 基于Liberant 8Fr和12Fr与Penumbra Lightning 7Fr和Lightning 12Fr的台架数据。180度时的扭矩响应
¶ Price point established for entire catheter set including both clotbuster and dilator. Penumbra separator sold separately at an added cost.
¶ 整套导管的价格已确定,包括血栓清除器和扩张器。Penumbra分离器需额外付费单独购买。
# Based on decreased need to remove mechanical aspiration to complete the procedure
# 基于减少机械抽吸以完成手术的需求
* Medtronic is the sole distributor of Excipio Thrombectomy Devices. Excipio is a registered trademark of Contego Medical, Inc.
* 美敦力是Excipio血栓切除装置的唯一经销商。Excipio是Contego Medical, Inc.的注册商标。
Footnotes
脚注
Data on file at Medtronic D01380628 In-Vitro Marketing Testing on Liberant and Penumbra Indigo System Report. Bench testing may not be indicative of clinical performance.
数据存档于美敦力公司,文件编号D01380628,《Liberant和Penumbra Indigo系统报告的体外市场测试》。台架试验可能不能反映临床表现。
About Medtronic
美敦力公司简介
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严峻的健康问题。我们的使命——减轻病痛、恢复健康、延长寿命——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、无尽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 .
随着我们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带来更好的结果,期待我们做得更多。在我们所做的每一件事中,我们都在创造非凡。欲了解有关美敦力的更多信息,请访问。
www.Medtronic.com
www.美敦力.com
and follow on
并继续关注
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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所述的风险和不确定性。实际结果可能与预期结果有重大差异。
Contacts:
联系人:
Erin Burns
艾琳·伯恩斯
Public Relations
公共关系
+1-612-827-8952
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Ryan Weispfenning
瑞安·魏斯芬宁
Investor Relations
投资者关系
+1-763-505-4626
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IR and media FAQs
投资者关系和媒体常见问题解答
Q. What does the Liberant system treat?
问:Liberant系统治疗什么?
A.
A.
The Liberant™ mechanical aspiration thrombectomy system (“the Liberant system”) is indicated for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems.
Liberant™ 机械抽吸血栓切除系统(“Liberant 系统”)适用于从外周动脉和静脉系统的血管中移除新鲜、柔软的栓子或血栓。
Q. Why is PVH entering the thrombectomy market?
问:为什么PVH进入血栓切除市场?
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We see tremendous growth potential in the market and we are well positioned to leverage core competencies in catheter design as well as technology from our Neurovascular operating unit to expand our portfolio to be even more comprehensive.
我们看到市场有巨大的增长潜力,我们有能力利用我们在导管设计以及神经血管业务部门技术方面的核心竞争力,来进一步扩充我们的产品线,使其更加全面。
Q. How does entry into the market complement Medtronic’s existing peripheral vascular portfolio?
问:进入市场如何补充美敦力现有的外周血管产品组合?
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This market is a natural fit for the PVH business because many of our existing customers — interventional radiologists, interventional cardiologists, and vascular surgeons — perform thrombectomy procedures. The Liberant system is compatible with the Excipio™* thrombectomy device, a device from Contego Medical for which Medtronic is the sole distributor.
这个市场非常适合PVH业务,因为我们的许多现有客户——介入放射科医生、介入心脏病专家和血管外科医生——都进行血栓切除手术。Liberant系统与Contego Medical的Excipio™*血栓切除设备兼容,而美敦力是该设备的独家经销商。
Entering the thrombectomy market will be complementary to our existing products in the arterial, arteriovenous, and venous space..
进入血栓切除市场将与我们现有的动脉、动静脉和静脉领域的互补。
Q. What is the addressable market for thrombectomy?
问:血栓切除术的可寻址市场是什么?
A. Thrombectomy is one the largest and highest growing opportunities in med tech, with a $1.1B market size and a 9.5% growth projection CAGR (5 years; FY24 – FY29).
A. 血栓切除术是医疗技术领域规模最大且增长最快的机会之一,市场规模达11亿美元,预计未来五年(2024财年 - 2029财年)的年均复合增长率(CAGR)为9.5%。
Q. Where is the Liberant system available?
问:Liberant系统在哪里可以使用?
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The Liberant system has been cleared by the U.S. Food and Drug Administration (“FDA”) and is currently available in the United States.
Liberant系统已获得美国食品药品监督管理局(“FDA”)的批准,目前在美国有售。
Q. What clinical evidence do you have planned for the Liberant system?
问:你们为Liberant系统计划了哪些临床证据?
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The Liberant system received 510(k) clearance from the FDA in June 2025. Medtronic is initiating a multicenter, real-world clinical assessment to evaluate periprocedural device performance of the Liberant system in the treatment of fresh, soft emboli or thrombi in the vessels of the peripheral arterial and venous systems. .
Liberant系统于2025年6月获得FDA的510(k)许可。美敦力正在启动一项多中心、真实世界的临床评估,以评估Liberant系统在治疗外周动脉和静脉系统血管中的新鲜、柔软栓子或血栓时的围手术期设备性能。