雅培UltiSynq除颤导线获FDA批准与欧盟CE标志：一根导线同时起搏与除颤
雅培公司（Abbott）11月10日在伊利诺伊州 Abbott Park 宣布，其 UltiSynq 除颤导线获得美国食品药品管理局（FDA）批准，并同时获得欧盟 CE 标志。这款导线植入心脏左束支区域，可在同一根导线上同时提供传导系统起搏与除颤治疗，为既需要起搏、又需要除颤保护的患者多了一个选择。
这款导线面向因危及生命的快速性心律失常而面临心脏性猝死风险的患者，长期连接兼容的植入式心律转复除颤器（ICD）或心脏再同步治疗除颤器（CRT-D）系统使用。它此前已被 FDA 授予突破性医疗器械认定，该计划为可能更有效治疗危及生命或不可逆衰弱性疾病的器械加快开发与优先审查。
批准依据是 ASCEND CSP IDE 试验。这是一项前瞻性、多中心、全球研究，评估 UltiSynq 导线在 ICD 或 CRT-D 适应证患者中的安全性与有效性，临床试验登记号为 NCT06830746。2026年4月在心律学会年会公布的三个月结果显示，该导线达到全部预设的主要安全与有效性终点：205名受试患者中，导线植入成功率达98.5%，86%的患者实现或很可能实现左束支起搏，无重大并发症生存率为97.5%，且未报告与导线相关的重大安全事件。
雅培在公告中说，左束支区域起搏是传导系统起搏的一种方式，借助心脏自身的电传导系统工作，有助于恢复更协调的心跳。此次美欧同步获批后，美国与欧洲的临床医生在为同时需要起搏与除颤的患者选择导线时，将多一项经批准的方案。
（来源：雅培）
Abbott's UltiSynq Defibrillation Lead Wins FDA Approval and CE Mark: One Lead for Both Pacing and Defibrillation
Abbott announced on November 10 in Abbott Park, Illinois, that its UltiSynq defibrillation lead has received U.S. Food and Drug Administration (FDA) approval and a European CE Mark. Implanted in the heart's left bundle branch area, the lead is designed to deliver both conduction system pacing and defibrillation therapy through a single lead, giving patients who are candidates for both pacing and defibrillation protection an additional option.
The lead is intended for long-term attachment to compatible implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) systems in patients at risk of sudden cardiac death due to life-threatening tachyarrhythmias. It had previously been designated an FDA breakthrough device, a program that expedites development and prioritizes review of devices with the potential to more effectively treat life-threatening or irreversibly debilitating conditions.
The approvals were supported by the ASCEND CSP IDE trial, a prospective, multicenter, global study evaluating the safety and effectiveness of the UltiSynq lead in patients indicated for ICD or CRT-D therapy, registered as NCT06830746. Three-month results presented as late-breaking data at the Heart Rhythm Society annual meeting in April 2026 showed the lead exceeded all pre-specified primary safety and effectiveness endpoints: implantation succeeded in 98.5% of the 205 patients, 86% achieved true or likely left bundle branch pacing, the major complication-free rate was 97.5%, and no lead-related major safety events were reported.
Abbott said left bundle branch area pacing is a conduction system pacing approach that works with the heart's natural electrical system to help restore a more coordinated heartbeat. With the simultaneous U.S. and European approvals, clinicians in both regions gain an additional approved lead option for patients who need both pacing and defibrillation.
(Source: Abbott)
来源：雅培
发布：GSM·美国（发布链接）
图片来源：Wikimedia Commons（n28ive1 摄，CC BY）：植入式心律转复除颤器（ICD）实物资料图，非本次获批的 UltiSynq 导线本体
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