Medtronic has gained U.S. Food and Drug Administration (FDA) approval for its PulseSelect pulsed field ablation (PFA) system to treat both paroxysmal and persistent atrial fibrillation (AFib). This marks the first FDA approval for PFA technology and follows the recent CE mark for PulseSelect PFA in November. .

美敦力已获得美国食品和药物管理局（FDA）的批准，用于治疗阵发性和持续性心房颤动（AFib）的脉冲选择脉冲场消融（PFA）系统。这标志着美国食品和药物管理局（FDA）首次批准PFA技术，并继11月PulseSelect PFA的CE标志之后。。。

PulseSelect PFA offers rapid, effective pulmonary vein isolation (PVI) via consistent, predictable energy delivery and catheter maneuverability, Medtronic claims. Its safety, efficacy, and efficiency are supported by the PULSED AF study, which demonstrated 0.7% safety event rate and clinical success rates of 80% for both paroxysmal and persistent AF patients. .

美敦力声称，PulseSelect PFA通过一致、可预测的能量输送和导管可操作性提供快速、有效的肺静脉隔离（PVI）。脉冲AF研究支持其安全性，有效性和有效性，该研究显示阵发性和持续性AF患者的安全事件发生率为0.7%，临床成功率为80%。。。

'Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency.  It's a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients,' said Rebecca Seidel, SVP and president of Medtronic’s Cardiac Ablation Solutions business.

“推出首个FDA批准的PFA技术不仅仅是一个里程碑；PulseSelect PFA系统为AF消融的安全性设定了新的标准，具有出色的疗效和效率。美敦力心脏消融解决方案业务总裁兼高级副总裁丽贝卡·赛德尔（RebeccaSeidel）说，这是朝着实现我们为患者提供破坏性电生理解决方案的愿景迈出的重要一步。

'The PulseSelect PFA system, together with the CE marked Affera mapping and ablation system and our strong Cryo platform, enables us to provide a broad portfolio of solutions to clinicians and their patients, all developed with years of research and supported by compelling scientific evidence.'.

“PulseSelect PFA系统，加上CE标记的Affera标测和消融系统以及我们强大的冷冻平台，使我们能够为临床医生及其患者提供广泛的解决方案组合，所有这些都是经过多年的研究开发并得到令人信服的科学证据支持的。”。

PulseSelect was designed as a “plug-and-play” system that can be used with any mapping system or with only fluoroscopy. Its built-in safety features include a phrenic nerve test pulse, a non-therapeutic, low-voltage pulse that preemptively assess catheter proximity to the phrenic nerve before delivering a therapeutic application. .

PulseSelect设计为“即插即用”系统，可与任何绘图系统或仅荧光透视一起使用。其内置的安全功能包括膈神经测试脉冲，这是一种非治疗性的低压脉冲，可在提供治疗应用之前先评估导管与膈神经的接近程度。。。

Fixed spacing for the system’s nine-electrode catheter produces a predictable, consistent electric field for contiguous ablation, and can be used for pacing and sensing as well.

该系统的九电极导管的固定间距为连续消融产生可预测的一致电场，也可用于起搏和传感。

PulseSelect PFA is the first FDA breakthrough-designation PFA technology to be approved. Medtronic expects commercialization to begin in early 2024.

PulseSelect PFA是FDA首次批准的突破性PFA技术。美敦力预计商业化将于2024年初开始。