/PRNewswire/ -- Pulsecare Medical, a pioneer in cardiovascular intervention technologies, announced that its innovative

/PRNewswire/ -- Pulsecare Medical，心血管介入技术的先驱，宣布其创新的

NxPFA™

NxPFA™

nanosecond pulsed field ablation (ns-PFA) systemhas received marketing approval from

纳秒脉冲场消融（ns-PFA）系统已获得上市批准。

China's

中国的

National Medical Products Administration (NMPA). As the world's first third-generation ns-PFA system utilizing high-voltage nanosecond pulses for pulmonary vein isolation (PVI) in atrial fibrillation (AF) treatment, this breakthrough marks the dawn of the PFA 3.0 era and represents the innovative capabilities of Pulsecare Medical in cardiovascular multimodal therapy..

国家药品监督管理局（NMPA）。作为全球首款利用高压纳秒脉冲进行房颤（AF）治疗中肺静脉隔离（PVI）的第三代非热消融系统，这一突破标志着PFA 3.0时代的到来，也体现了 PulseCare Medical在心血管多模态治疗中的创新能力。

Global_First_Nanosecond_Pulsed_Field_Ablation_System

全球首个纳秒脉冲电场消融系统

The World's First Commercially Approved Nanosecond PFA

世界上首个商用获批的纳秒PFA

PFA has revolutionized AF treatment through its tissue selectivity, safety, and procedural efficiency. Yet, early-generation systems using microsecond pulses face key challenges—excessive muscle stimulation, reliance on general anesthesia, and risks like hemolysis and gas embolism—that limit broad adoption..

PFA通过其组织选择性、安全性和手术效率，彻底改变了房颤治疗。然而，使用微秒脉冲的早期系统面临关键挑战——过度的肌肉刺激、对全身麻醉的依赖以及溶血和气体栓塞等风险——这些限制了其广泛应用。

As the world's first and only commercially available nanosecond PFA system, NxPFA™ represents the 'Next of PFA' generation. It combines the MaviPulse™ high repetition frequency ns-PFA console with the InteShot™ basket-shaped catheter to deliver irreversible electroporation of cardiomyocytes via high-voltage nanosecond pulses, effectively overcoming key limitations of microsecond PFA (μs-PFA) technologies:.

作为世界上首个且唯一商用的纳秒PFA系统，NxPFA™代表了“PFA的下一代”。它结合了MaviPulse™高重复频率ns-PFA控制台和InteShot™篮状导管，通过高压纳秒脉冲实现心肌细胞的不可逆电穿孔，有效克服了微秒PFA（μs-PFA）技术的关键局限性。

Significantly reduces neuromuscular stimulation, enabling procedures under conscious sedation, improving patient comfort and lowering anesthesia risks;

显著减少神经肌肉刺激，使得在清醒镇静下进行手术成为可能，提高患者舒适度并降低麻醉风险；

Combines nanosecond pulses with a basket-shaped catheter to ensure optimal electrode-tissue contact and high success rates, while shortening procedural time;

结合纳秒级脉冲与篮状导管，确保电极与组织的最佳接触和高成功率，同时缩短手术时间；

Substantially lowers intravascular gas formation, lowering the risk of stroke or systemic embolism;

显著降低血管内气体形成，降低中风或系统性栓塞的风险；

Minimizes erythrocytic damage and post-procedural bilirubin elevation, reducing potential kidney injury.

最小化红细胞损伤和术后胆红素升高，减少潜在的肾损伤。

NxPFA™ Demonstrates Outstanding Efficacy and Safety

NxPFA™ 展现出卓越的疗效和安全性

The NxPFA

NxPFA

system has been clinically validated through the SCENA-AF multicenter registration trial, which enrolled 166 patients with paroxysmal atrial fibrillation. The data has been acknowledged by NMPA and will soon be published in an academic journal. Key outcomes include:

系统已通过SCENA-AF多中心注册试验进行了临床验证，该试验招募了166名阵发性心房颤动患者。数据已得到国家药品监督管理局（NMPA）的认可，并将很快在学术期刊上发表。关键结果包括：

100% acute pulmonary vein isolation success rate

肺静脉隔离成功率100%

88.27% one-year treatment success rate (PPS)

88.27% 的一年治疗成功率（PPS）

No device-related serious adverse events reported

未报告与设备相关的严重不良事件

Over 92.8% of procedures completed under conscious sedation, with excellent intraoperative tolerance.

超过 92.8% 的手术在清醒镇静下完成，术中耐受性极佳。

These results confirm NxPFA

这些结果证实了NxPFA。

's strong performance in efficacy, safety, efficiency, and patient comfort. It remains the only PFA system globally to achieve one-shot PVI under conscious sedation with high success, marking the debut of the third-generation nanosecond PFA era.

在有效性、安全性、效率和患者舒适度方面的强劲表现。它仍然是全球唯一一个在清醒镇静下实现一次性高成功率PVI的PFA系统，标志着第三代纳秒级PFA时代的到来。

'NxPFA

'NxPFA

's approval is not only a major milestone for Pulsecare Medical but also a transformative breakthrough for cardiac electrophysiology. With NxPFA

的批准不仅是Pulsecare Medical的一个重要里程碑，也是心脏电生理学的一次革命性突破。借助NxPFA

, we address critical clinical challenges and look forward to collaborating with global EP experts to shape the future of arrhythmia treatment—delivering smarter tools to physicians and safer, more effective, more comfortable therapies to patients,' said Dr.

“我们解决了关键的临床挑战，并期待与全球EP专家合作，共同塑造心律失常治疗的未来——为医生提供更智能的工具，为患者提供更安全、更有效、更舒适的治疗方案，”博士表示。

Javen Tan

谭家文

, CEO of Pulsecare Medical.

，Pulsecare Medical的首席执行官。

About PulseCare Medical

关于脉冲医疗

Founded in

成立于

July 2021

2021年7月

and headquartered in

总部位于

Shenzhen

深圳

,

，

Pulsecare Medical

脉冲医疗

is dedicated to the innovation and development of cardiovascular multimodal therapeutic devices. Backed by a rare cross-disciplinary team combining clinical and engineering expertise, the company is building a next-generation energy platform for interventional therapies. Pulsecare offers total solutions for cardiac electrophysiology and hypertension interventional therapy, aiming to lead in minimally and non-invasive treatments..

致力于心血管多模态治疗设备的创新和发展。凭借临床与工程专业知识相结合的罕见跨学科团队，公司正在构建用于介入治疗的下一代能量平台。脉冲医疗提供心脏电生理和高血压介入治疗的全面解决方案，旨在引领微创和非侵入性治疗的发展。