创新器械电话会 - 介入瓣膜 20251202 摘要 心脏瓣膜市场增速放缓，预计维持 20%左右增长，受市场成熟、医疗控 费及行业价格竞争影响。主流品牌包括佩佳、启明、精通和建世，其中 建世主营现金瓣膜，2025 年上半年植入量约 1,600 台，新进入者如乐 普新泰球扩瓣植入量较少。 甘肃省牵头的省级联盟集采预计降价幅度温和，参考各省最低官网价。 企业希望生物瓣与介入瓣、自膨瓣与球扩瓣分组，避免淘汰规则。预计 未来集采后，心脏瓣膜拿货价可能降至 12 万至 15 万之间，相当于原始 出厂价的 6 到 7 折。 各省逐步将 TAVR 纳入医保，但报销比例有限。启明、佩佳、新通等公 司在中西部区域提供 3~5 万元不等的补贴金额，相比以前有所减少。乐 普新在市场上的最低价为 10 万元，广州地区的挂网价大约为 15.8 万元 至 16 万元，成为其他省份降价时的重要参考。 短期内，心脏瓣膜市场格局不会发生显著变化。新进入者需通过报低价 获得准入或通过临床服务提升医院认可度以抢占市场份额。爱德华因全 球统一定价，难以大幅降价应对集采，且球扩瓣优势减弱。 Q&A 2025 年介入瓣膜的预计植入量和增速如何？市场上主 ...

Summary of the Conference Call on Electrophysiology Industry Overview - The electrophysiology (EP) industry in China is experiencing continuous growth, with a 10% increase in procedures in the first half of the year, and an expected nationwide growth of 10%-15% due to the adoption of new catheter ablation technologies like pulsed field ablation (PFA) and accelerated domestic substitution [2][3][4] - The patient base for atrial fibrillation (AF) is substantial, estimated at 14-18 million, with increasing incidence due to aging, although the penetration rate of catheter ablation remains low [2][4] Key Insights - **Procedure Growth**: The EP procedures are a highlight in the cardiovascular intervention field, with a 10% growth noted in a major center, and a higher national growth rate anticipated due to the increasing adoption of independent EP teams and local anesthesia techniques [3][4] - **Technology Trends**: - Cryoablation technology is being phased out, while radiofrequency ablation remains dominant. However, PFA is rapidly gaining traction due to its lower technical difficulty and higher safety profile [2][3][7] - In a specific center, radiofrequency ablation accounts for 60%-70% of procedures, while PFA represents 30%-40%, with expectations for PFA's share to increase further [7] - **Market Share**: In the thermal ablation market, Johnson & Johnson holds over 50% market share, Abbott has 30%-40%, and domestic brands have a smaller share. In the AF thermal ablation sector, Johnson & Johnson's market share exceeds 75% [2][9] Patient Treatment Dynamics - **Patient Willingness**: Paroxysmal AF patients typically try medication first, while persistent AF patients are more inclined to opt for catheter ablation due to poor medication efficacy [5][6] - **Success Rates**: Catheter ablation for AF has a high success rate of over 90%, but the recurrence rate is significant, especially for persistent AF [4][6] Competitive Landscape - **Domestic vs. International Brands**: In the PFA era, domestic brands like Jinjiang and Huitai are gaining market share due to their ability to perform procedures under local anesthesia, contrasting with foreign brands that rely on general anesthesia [10][11] - **Emerging Technologies**: The development of nanosecond PSA technology aims to reduce pain and anesthesia needs, although it is still in preclinical stages [15] Future Outlook - **Market Dynamics**: The competitive landscape is shifting, with foreign manufacturers like Abbott lagging behind in innovation. Domestic brands with robust 3D systems are expected to emerge as key players [26] - **Price Trends**: The overall trend in medical pricing is expected to become more affordable, although specific pricing for PFA terminal products remains undisclosed [27][28] Regulatory and Guideline Changes - **Clinical Guidelines**: The U.S. has updated its guidelines to position electrophysiology as a first-line treatment, which is expected to influence domestic guidelines in China [30] Additional Considerations - **One-stop Surgery**: The concept of one-stop surgeries combining electrophysiology and left atrial appendage closure is gaining traction, although it presents challenges in terms of cost and reimbursement [21][23] This summary encapsulates the key points from the conference call regarding the electrophysiology industry, highlighting growth trends, technological advancements, patient treatment dynamics, competitive landscape, future outlook, and regulatory changes.