波士顿科学PFA，有新进展

医疗器械创新网2025-07-10

2025年7月7日，波士顿科学公司（纽约证券交易所代码：BSX）宣布，其Farapulse脉冲场消融（PFA）系统已获美国食品药品监督管理局（FDA）批准，扩展其标签适用范围，新增对药物难治性、有症状的持续性心房颤动（AFib）的治疗许可。Farapulse系统作为治疗AFib的领先PFA技术之一，于去年首次获得FDA批准，通过导管精准输送脉冲场能量，靶向消融心脏异常组织，从而恢复心脏正常节律。...

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developments","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BSX":1},"content_text":"2025年7月7日，波士顿科学公司（纽约证券交易所代码：BSX）宣布，其Farapulse脉冲场消融（PFA）系统已获美国食品药品监督管理局（FDA）批准，扩展其标签适用范围，新增对药物难治性、有症状的持续性心房颤动（AFib）的治疗许可。Farapulse系统作为治疗AFib的领先PFA技术之一，于去年首次获得FDA批准，通过导管精准输送脉冲场能量，靶向消融心脏异常组织，从而恢复心脏正常节律。此次标签扩展后，该系统将适用于心脏异常跳动持续至少7天的持续性AFib患者，标志着其在临床应用中的又一重要进展。此次更新特别涉及Farawave PFA导管和Farawave Nav PFA导管的使用说明修订，明确纳入持续性AFib的治疗指征。这一决定基于今年4月公布的ADVANTAGE AF试验结果，该试验证实了Farapulse系统在治疗此类复杂心律失常中的安全性和有效性。波士顿科学公司曾预计FDA将在2025年下半年完成此项批准，实际获批时间显著提前。波士顿科学公司透露，预计未来几个月内，Farapulse系统将在日本和中国相继获得CE标志及监管批准，进一步扩大其全球标签适用范围。与此同时，公司已启动ReMatch IDE多中心临床试验，覆盖美国及亚洲40个医疗中心，计划招募约375名持续性AFib患者参与研究。ReMatch IDE试验聚焦两大核心方向：一是评估Farawave PFA导管在后壁消融及肺静脉隔离中的表现，二是探索Farapoint导管辅助三尖瓣峡部消融术和二尖瓣峡部左心房消融术的联合应用。试验对象包括既往接受过PFA、射频或冷冻消融治疗后复发的患者，旨在填补当前治疗领域中对复杂心律失常及消融再处理患者的研究空白。波士顿科学AFib Solutions首席医疗官Brad Sutton博士表示：“此次标签更新是我们基于临床证据与全球实践经验的又一里程碑，彰显了安全、高效的消融技术对推动AF治疗变革的重要性。我们期待通过ReMatch IDE等前沿研究，深化对Farapulse系统在复杂病例中应用的理解，为更多患者提供创新解决方案。”据悉，热消融技术（如射频、冷冻消融）仍是当前房颤治疗的主流手段，但存在组织损伤风险及特定解剖部位消融难度高等挑战。Farapulse系统凭借其非热能消融机制，有望为临床提供更精准、安全的治疗选择。▲文章来源：Medtech Dive 医潜▲转载请标注以上来源声明：本文仅作信息传递之目的，仅供参考。本文不对投资及治疗构成任何建议，请谨慎甄别。如涉及作品内容、版权和其它问题，为保障双方权益，请与我们联系，我们将立即处理。如有平台转载本篇文章，须自行对该篇文章负责，医疗器械创新网不对转载引起的二次传播负责。往/期/回/顾GE重大人事变动，新总裁“五一”到任！巨头混战！谁能拿下BD2000亿“大蛋糕”？卷哭同行，联影再包揽1.13亿大标！","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; 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