波士顿科学发布：PFA临床里程碑

器械之家2025-05-01

器械之家医疗器械媒体报道先锋分享专业医疗器械知识关注来源：医械一线，未经授权不得转载，且24小时后方可转载。波士顿科学公司近日公布了其ADVANTAGE AF临床试验第二阶段的完整12个月数据，进一步验证了Farapulse脉冲场消融（PFA）系统及Farapoint PFA导管在持续性心房颤动（房颤）治疗中的突破性价值。该研究结果于2025年心律协会（HRS）年会期间在第二届PFA Live ...

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HDx标测系统无缝对接，实现导管定位的实时可视化。这一设计显著提升了复杂解剖结构（如三尖瓣峡部）消融的精准度，降低了手术风险。02临床意义及注册进展持续性房颤因病程长、心房重构严重，传统热消融治疗复发率高达30%-50%。ADVANTAGE AF试验首次证明，脉冲场消融可在不依赖高温或低温能量的情况下，实现高效且持久的心律控制。研究首席研究员、西奈山卫生系统Vivek Reddy教授指出：“连续心律监测揭示了无症状复发的真实比例，这对制定个体化治疗策略至关重要。Farapulse系统已展现出成为持续性房颤一线疗法的潜力。”波士顿科学公司预计，美国FDA将于2025年下半年批准Farapulse系统扩展适应症至持续性房颤，并同步推进Farapoint导管在欧美市场的上市。此外，公司正整合LUX-Dx ICM系统与消融设备，构建“治疗-监测-管理”全流程解决方案。BTIG分析师Marie Thibault评论称：“波士顿科学在PFA领域的先发优势将巩固其电生理市场领导地位，并推动全球市场规模持续扩容。”房颤是全球发病率最高的心律失常之一，持续性房颤因病程长、复发率高，临床治疗挑战巨大。Advantage 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