Shanghai, China, 03 March 2025 – MicroPort

中国上海，2025年3月3日 - 微创

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CardioAdvent, a subsidiary of MicroPort

心脉医疗，微创医疗的子公司

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CardioFlow, has received EU Medical Device Regulation (MDR) certification for its AnchorMan

CardioFlow 已获得其 AnchorMan 的欧盟医疗器械法规 (MDR) 认证。

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Left Atrial Appendage Closure System (AnchorMan

左心耳封堵系统 (AnchorMan)

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LAAC system), securing market approval in just 14 months from registration (Registration Number: MDR 795462) . Its companion device, the AnchorMan

左心耳封堵术系统），从注册到获得市场批准仅用了14个月（注册号：MDR 795462）。其配套设备 AnchorMan

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Left Atrial Appendage Access System, also received approval.

左心耳通路系统也获得了批准。

Compared to open and closed left atrial appendage occluders, the AnchorMan

与开放式和封闭式左心耳封堵器相比，AnchorMan

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LAAC system integrates the advantages of both. Its semi-closed structure, featuring 12 “3D folding” units and an advanced frame design, addresses key challenges associated with deep sheath placement in conventional plug-in closure systems while ensuring stable anchoring. The device’s rounded, soft distal end minimizes trauma to LAA tissue, while its dense NiTi alloy frame design ensures tight conformity to the LAA anatomy, providing superior sealing performance.

LAAC系统结合了两者的优点。其半封闭结构具有12个“3D折叠”单元和先进的框架设计，解决了传统插塞式闭合系统中与深鞘放置相关的关键挑战，同时确保稳定的锚定。装置的圆润柔软远端最大限度地减少了对LAA组织的损伤，其密集的镍钛合金框架设计确保与LAA解剖结构紧密贴合，提供卓越的密封性能。

Additionally, its two deployment options - advancement and unsheathing - offer physicians more flexibility during procedures..

此外，它的两种部署选项——推进和出鞘——为医生在手术过程中提供了更大的灵活性。

In May 2023, the results of the pre-market clinical study SAFE PROTECT – a prospective, multicenter, head-to-head randomized controlled trial - were unveiled for the first time at the European Congress of Percutaneous Cardiovascular Interventions (Euro-PCR). The study successfully reached its primary endpoint and secondary efficacy endpoints within one year, with results showing low incidences of stroke, systemic embolism, major bleeding, transient ischemic attack (TIA), device-related complications, and device-related thrombus (DRT) among patients.

2023年5月，欧洲经皮心血管介入会议（Euro-PCR）上首次公布了预市场临床研究SAFE PROTECT的结果。该研究是一项前瞻性、多中心、头对头的随机对照试验。研究在一年内成功达到了主要终点和次要疗效终点，结果显示患者的中风、系统性栓塞、严重出血、短暂性脑缺血发作（TIA）、器械相关并发症及器械相关血栓（DRT）的发生率较低。

This notably high clinical success rate and low adverse events at one year are attributed to its innovative design..

一年时显著高的临床成功率和低不良事件归因于其创新设计。

The successful EU certification of both the AnchorMan

AnchorMan 的成功通过欧盟认证

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LAAC system and its access device paves the way for MicroPort

左心耳封堵系统及其输送装置为微创医疗铺平道路

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CardioFlow’s expansion into the European market, reinforcing its commitments to stroke prevention in patients with atrial fibrillation.

CardioFlow拓展欧洲市场，进一步履行其对房颤患者中风预防的承诺。

Jeff Lindstrom, President of MicroPort

微创总裁林德斯坦·杰夫

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CardioFlow, stated, “This certification is a major milestone in our global journey. We remain dedicated to driving innovation, overcoming technological barriers, and expanding our interventional therapy portfolio to provide more comprehensive solutions for patients worldwide.”

CardioFlow 表示：“这一认证是我们全球征程中的一个重要里程碑。我们将继续致力于推动创新，克服技术障碍，并扩展我们的介入治疗产品组合，为全球患者提供更全面的解决方案。”

Guoming Chen, Chairman of MicroPort

陈国明，微创医疗董事长

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CardioFlow, commented, “Following the success of VitaFlow Liberty

心流科技评论道：“继VitaFlow Liberty取得成功之后，

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Transcatheter Aortic Valve and Retrievable Delivery System, AnchorMan

经导管主动脉瓣及可回收输送系统，AnchorMan

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LAAC system and its access system represent our second major entry into the EU market. As these products gain traction across Europe, they will create strong synergies, further enhancing brand recognition and market share, and jointly elevating our international presence.”

LAAC系统及其接入系统代表着我们进入欧盟市场的第二个重要入口。随着这些产品在欧洲各地逐渐受到关注，它们将产生强大的协同效应，进一步提升品牌知名度和市场份额，共同提升我们的国际影响力。”

About MicroPort

关于微创

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CardioFlow

心血管流量

Founded in 2015, MicroPort

成立于2015年，微创

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CardioFlow (MicroPort

心流（微创）

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CardioFlow Medtech Corporation; HKEX: 02160) is a leading medical device company focusing on research, development and commercialization of innovative transcatheter and surgical solutions for structural heart disease.

心通医疗；港交所：02160）是一家领先的医疗器械公司，专注于结构性心脏病的创新经导管和外科解决方案的研究、开发和商业化。

MicroPort

微创

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CardioFlow’s self-developed transcatheter aortic valve implantation series products are successfully used in more than 700 core hospitals worldwide. In addition, MicroPort

CardioFlow自主研发的经导管主动脉瓣植入系列产品已成功应用于全球700多家核心医院。此外，MicroPort

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CardioFlow has established a strategic Research and Development pipeline covering TAVI (transcatheter aortic valve treatment) products, left atrial appendage closure systems, transcatheter mitral valve treatment products, transcatheter tricuspid valve treatment products, and surgical accessories through in-house development and collaboration with global partners.

CardioFlow 已经建立了覆盖 TAVI（经导管主动脉瓣治疗）产品、左心耳封堵系统、经导管二尖瓣治疗产品、经导管三尖瓣治疗产品以及手术配件的战略研发管线，通过自主研发和与全球合作伙伴的合作进行开发。

MicroPort.

微创。

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CardioFlow is committed to providing total solutions for structural heart diseases, delivering high-quality therapeutic solutions to patients and physicians across the globe.

CardioFlow 致力于为结构性心脏病提供全面的解决方案，为全球患者和医生提供高质量的治疗方案。

More information is available at

更多信息请访问

www.en.cardioflowmedtech.com

www.en.cardioflowmedtech.com