医药生物行业动态点评：波科脉冲消融系统NMPA获批，领跑全球电生理PFA市场

Industry Investment Rating - Stronger than the market (maintained) [4] Core Views - The Chinese electrophysiology PFA market, characterized by high growth potential and low penetration, is poised for significant expansion [2] - The FARAPULSE series of PFA products from Boston Scientific has received NMPA approval, marking a new era in atrial fibrillation treatment in China [2] - The PFA market in China is projected to grow from RMB 1.3 billion in 2025 to RMB 16.3 billion in 2032, with its share of the overall electrophysiology device market increasing from 8.18% to 38.87% over the same period [2] - Boston Scientific's FARAPULSE PFA system has treated over 70,000 patients globally, demonstrating superior safety and efficacy compared to traditional thermal ablation methods [3] - The electrophysiology division of Boston Scientific experienced a 70% global sales growth in Q1 2024, with an 85% increase in the US market, driven by the FDA approval of the FARAPULSE PFA system [3] Market and Technology Insights - The FARAPULSE PFA system is the only PFA product globally to receive approvals from the EU CE, US FDA, and China NMPA [2] - The FARAPULSE system offers a novel treatment option for drug-refractory, recurrent, and symptomatic paroxysmal atrial fibrillation, differing from traditional thermal ablation [2] - The FARAWAVE ablation catheter's unique design allows for flexible adjustment to petal and basket shapes, adapting to patient pulmonary vein morphology and reducing complications [3] - Clinical trials, including the ADVENT study, have shown that the FARAPULSE PFA system is non-inferior to traditional thermal ablation in safety and efficacy, with significantly shorter ablation times [3] - The MANIFEST-17K registry study involving over 17,000 patients reported no cases of permanent phrenic nerve palsy, pulmonary vein stenosis, or esophageal injury [3] Key Companies to Watch - Boston Scientific (BSX.N), a global leader in electrophysiology PFA technology [2] - Domestic companies with leading PFA layouts: HuiTai Medical (688617.SH) and MicroPort EP (688351.SH) [2]