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].
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思宇MedTech·2025-04-22 04:25