国家级创新医疗器械是指通过国家药监局创新医疗器械特别审批通道注册的医疗器械产品，需满足 国内首创、国际领先、临床价值显著等条件。继8月25日东软医疗系统股份有限公司全国首台"光子计数 CT"顺利获批之后，9月29日鹏悦科技又有两个产品获批国家级第三类创新医疗器械，这也是东北三省 一区仅有的三个国家级创新医疗器械。 鹏悦科技根据北部战区总医院教授团队提出的将氩氦冷冻技术应用于外科治疗持续性房颤的创新性 需求，组建"联合攻关团队"，破解了传统冷冻技术存在的降温速度不够快、复温依赖自然过程等问题， 通过对"快速降温、主动复温、背侧反馈"这三大核心功能的攻克，将冷冻消融技术提升到了一个全新的 高度。临床试验结果显示，应用心脏冷冻消融系统术后半年的房颤转复有效率达80%，达到了国际领先 水平，实现了产品"从手术台上来，到手术台上去"。 "这是全球首款用于需外科治疗的成人心脏病患者持续性房颤的冷冻治疗系统，不仅能解决传统治 疗手段的弊端，而且大幅降低患者治疗费用。"杨双介绍，新产品计划于12月应用于临床。 近年来，省药监局持续加大对创新药械的精准帮扶行动，推动产业提质升级。同时不断优化审评审 批，加速创新成果转化。制定出 ...

Core Insights - Shenhe Reform and Innovation Demonstration Zone has achieved a significant milestone with the approval of Shenyang Pengyue Technology Co., Ltd.'s cardiac cryoablation device and disposable sterile cryoablation probe by the National Medical Products Administration, marking a breakthrough in domestic medical devices for cardiac atrial fibrillation treatment [1][2] Group 1: Product Overview - The cardiac cryoablation device is the core of a complete cryoablation system solution, responsible for precise control of refrigerant delivery and recovery, ensuring stability and safety during the ablation process [2] - The disposable sterile cryoablation probe is a key instrument that directly targets the myocardial area, made from special alloy materials, allowing for full-path cardiac ablation treatment with a single probe, significantly reducing treatment costs [2] Group 2: Technological Advancements - The device has achieved domestic technological breakthroughs in refrigerant selection, active rewarming design, probe vacuum insulation, and flexible structure, with its backside temperature feedback technology being an international first [2] - These advancements are expected to disrupt the long-standing dominance of foreign products in the relevant medical field, providing better treatment options for domestic clinicians and patients [2]

Core Viewpoint - The article highlights the recent approval of four innovative medical devices by the National Medical Products Administration in China, indicating a growing trend in the development and registration of innovative medical technologies in the country [1][8]. Group 1: Approved Products - The approved products include: 1. "Extended Depth of Focus Intraocular Lens" by Aibono Medical Technology Co., Ltd. [1] 2. "Cardiac Cryoablation Device" and "Single-use Sterile Cryoablation Probe" by Shenyang Pengyue Technology Co., Ltd. [1][8] 3. "Cross-linked Polyisobutylene Aspheric Intraocular Lens" by Xi'an Yandale Medical Technology Co., Ltd. [1][8] - As of now, a total of 373 innovative medical devices have been registered in China [1]. Group 2: Company Profiles - Aibono Medical Technology Co., Ltd. is an innovative ophthalmic medical device manufacturer listed on the Sci-Tech Innovation Board, focusing on cataract surgery, myopia control, and vision care solutions. The company reported a total revenue of 787 million yuan (approximately $114 million) with a year-on-year growth of 14.72% and a net profit of 213 million yuan (approximately $31 million) with a growth of 2.53% in the first half of 2025 [6]. - Shenyang Pengyue Technology Co., Ltd., established in 2020, specializes in digital intelligent precision medical fields and has developed a cardiac cryoablation system with independent intellectual property rights [10]. - Xi'an Yandale Medical Technology Co., Ltd. focuses on intraocular lenses for cataract treatment and is led by a team of experts, including members from the American Academy of Engineering [18]. Group 3: Product Details - The "Extended Depth of Focus Intraocular Lens" is designed for vision correction after cataract surgery, featuring a one-piece, foldable design made from a combination of ethyl acrylate and methyl methacrylate [5]. - The "Cardiac Cryoablation Device" is used for treating persistent atrial fibrillation in adult patients, utilizing argon gas for rapid cooling of myocardial cells [9]. - The "Cross-linked Polyisobutylene Aspheric Intraocular Lens" is notable for its high refractive index and is designed for implantation through a small incision, providing an improved visual experience for cataract patients [15].