2.产品名称：射频消融系统 申请人： 北京佰仁医疗科技股份有限公司 北京佰仁医疗科技股份有限公司，成立于2005年，是一家致力于动物源性植介入高值医疗器械研发与生产的高新技术企业。公司自主研发动物组织工程和原创化学 改性处理技术，目前已获批准 17个Ⅲ类医疗器械产品 ，公司是国内技术领先的动物源性植介入医疗器械研发平台企业，产品覆盖心脏瓣膜置换与修复、先天性心 脏病植介入治疗以及外科软组织修复三大领域。 2025年9月5日，NMPA公布了创新医疗器械特别审查申请审查结果公示（2025年第8号），有 8 款产品 进入创新通道。 1.产品名称：超声辅助溶栓设备及一次性使用超声辅助溶栓导管 申请人： 上海心弘生命科学有限公司 心弘生命成立于2022年6月，注册于上海闵行区，公司是一家致力于打造以超声能量技术和药械联合技术为平台的创新超声心血管医疗科技企业。 心弘生命创始团队拥有国内稀缺的研发及产业化经验， 公司创始人 吴常生 曾为微创医疗冠脉明星产品Firehawk（火鹰）靶向洗脱药物支架系统的项目负责人 ，拥 有近20年产业研发及管理经验。核心创始团队兼具超声能量研发、药械技术协同、注册质量管理、产品产业转化、创 ...

Core Viewpoint - The article discusses the advancements and market potential of radiofrequency ablation technology, particularly in the treatment of atrial fibrillation, highlighting the increasing demand driven by an aging population and the introduction of innovative products by Medtronic [1][3][7]. Summary by Sections Atrial Fibrillation and Market Demand - Atrial fibrillation (AF) is a common arrhythmia characterized by rapid and irregular heartbeats, affecting a large patient population. By 2025, the number of AF patients is expected to reach 22.67 million, with a compound annual growth rate (CAGR) of 2.85% from 2021 to 2025, indicating a high demand for surgical interventions [3][4]. Radiofrequency Ablation Overview - Traditional methods such as radiofrequency and cryoablation have become first-line treatments for AF. Radiofrequency ablation is noted for its effectiveness and safety, utilizing high-frequency electromagnetic waves to generate heat that destroys targeted tissue [4][6]. Market Growth and Drivers - The global radiofrequency ablation market was valued at approximately $2 billion in 2019 and is projected to grow to about $4 billion by 2027, with a CAGR of 8.5%. This growth is fueled by technological advancements, broader applications beyond cardiac diseases, and support from governments and healthcare institutions [7][10]. Medtronic's Product Innovations - Medtronic has introduced the PulseSelect system, a pulsed field ablation (PFA) product approved by NMPA, FDA, and CE, which is effective for both paroxysmal and persistent AF. Its design allows for targeted treatment with minimal damage to surrounding tissues [14][15][24]. - The Affera system, another Medtronic product, combines pulsed field and radiofrequency ablation, enhancing the precision and efficiency of cardiac procedures [23][28]. Medtronic Company Overview - Medtronic, established in 1949, is a leading global medical technology company with over 95,000 employees, focusing on chronic disease management across various medical fields. In the fourth fiscal quarter of 2025, the company reported net sales of $8.93 billion, up from $8.59 billion in the previous year [33][34].

盈利预测与投资建议。预计2025-2027 年归母净利润分别为7.1、8.6、10.5 亿元，公司作为内镜诊疗创 新器械龙头，全球竞争力不断提升，维持"买入"评级。 风险提示：国际贸易关税风险、研发失败风险、政策控费风险、汇率风险、新品放量不及预期风险。 海外高速放量，渠道建设日益完备。分区域看，国内市场销售收入约13.8 亿元（+2.1%），国际市场销 售收入约13.6 亿元（+30.4%）。2024 年国际形势复杂多变，全球面临大国博弈、地区冲突和多重挑 战。国内医改持续深化，对医疗器械行业产生深远影响。医用耗材集采覆盖面进一步扩大，更多企业加 入竞争，价格持续走低。2024 年公司积极推动全球管理架构升级，设立欧洲区域总部，优化管理欧洲 各营销子公司及非洲、中东等地区业务资源，欧洲区域业绩显著提升；加强美洲地区团队建设，不断细 化营销区域，优化营销战略，美国自有品牌销售持续保持较快增长。 内镜设备耗材化趋势初现，聚焦一次性内镜技术夯实第二增长曲线。一系列创新产品获得市场准入，胰 腺囊肿引流支架获得国产品牌第一张注册证，子公司康友医疗的TTS 微波消融产品完成 FDA、MDR 注 册，射频消融系统甲状腺和 ...