报名：首届全球骨科大会 | 议程更新 报名：首届全球心血管大会 | 重磅亮点 合作伙伴征集：2025全球手术机器人大会 2025 年 4 月 21 日，国家药品监督管理局批准了 四川锦江电子医疗器械科技股份有限公司 （简称" 锦江电子 "）的 " 一次性使用磁定位压力监测脉冲电场 消融导管 "（国械注准 20253010788 ）创新产品注册申请。 截至目前，我国上市的创新医疗器械累计 346 项 。 该产品由头端、管身、手柄、连接电缆组成，与公司生产的心脏脉冲消融仪配合使用，主要用于 阵发性室上性心动过速治疗 。 一次性使用磁定位压力监测脉冲电场消融导管通过对 消融头端结构 的创新设计，实现高压脉冲能量源在目标组织上的精准施加。该产品采用局部区域多电极 设置方式，在提升消融头端应对各种复杂微细组织结构适应性的同时， 可实时显示导管位置和头端压力监测值 ，有效提高手术效率、降低患者心脏穿孔并发 症。 此次获批的 PulsedFA ® FocalPoint 导管 是锦江电子 获批 上 市的 第2款自主研发的 PFA 脉冲电场消融导管 （第1款为 PulsedFA ® 一次性使用心脏脉冲 电场消融导管 ），且同为 ...

Core Viewpoint - The article highlights the approval of the PulsedFA® FocalPoint catheter by the National Medical Products Administration (NMPA) in China, marking a significant advancement in the treatment of paroxysmal supraventricular tachycardia and expanding the product line of Sichuan Jinjiang Electronic Medical Equipment Technology Co., Ltd. [1][2][4] Product Overview - The PulsedFA® FocalPoint catheter is designed for cardiac pulsed field ablation (PFA) and is used in conjunction with the company's cardiac pulsed ablation system. It features an innovative design that allows for precise application of high-voltage pulse energy to target tissues, enhancing surgical efficiency and reducing complications such as cardiac perforation [4][6]. - This is the second PFA catheter developed by the company, following the first PulsedFA® catheter, and it is part of the NMPA's green channel for innovative products, indicating its importance in the rapid arrhythmia treatment market [4][6]. Market Potential - The market for PFA in China is projected to reach 1.3 billion yuan by 2025, with a compound annual growth rate (CAGR) of 43.73%, expected to grow to 16.3 billion yuan by 2032. The PFA market's share of the overall electrophysiology device market is anticipated to increase from 8.18% in 2025 to 38.87% in 2032 [8]. Clinical Research - A clinical trial led by the electrophysiology team at West China Hospital evaluated the safety and feasibility of the PulsedFA® FocalPoint catheter in patients with atrioventricular nodal reentrant tachycardia (AVNRT). The study reported a 100% acute ablation success rate, with all patients maintaining sinus rhythm at the six-month follow-up without any adverse events [14][18][22]. Company Background - Sichuan Jinjiang Electronic was established in 2002 and is one of the few companies in China with a complete line of cardiac electrophysiology products. The company focuses on developing a three-dimensional PFA treatment solution and offers a range of products including mapping systems, ablation devices, and related consumables [24][28]. - The company has successfully raised over 700 million yuan in financing from notable investors and submitted an IPO application to the Sci-Tech Innovation Board to raise 2.691 billion yuan [28].