VANCOUVER, British Columbia--(BUSINESS WIRE)--Kardium Inc., a private medical device company that has developed the Globe® System for the treatment of atrial fibrillation (AF), announced positive results of the 1-year outcomes of the First-in-Human PULSE-EU Trial. These findings were presented as late-breaking clinical data at the Heart Rhythm Society (HRS) 2024 Annual Meeting and simultaneously published in the Heart Rhythm Journal..

不列颠哥伦比亚省温哥华市——（商业新闻短讯）——Kardium Inc.是一家私人医疗器械公司，开发了用于治疗心房颤动（AF）的Globe®系统，该公司宣布了第一次人体PULSE-EU试验的1年结果的积极结果。这些发现在心律协会（HRS）2024年会上作为最新的临床数据发表，并同时发表在《心律杂志》上。。

“I am very excited by the results of the PULSE-EU Study with the Globe Pulsed Field System” said Dr. Vivek Reddy of The Mount Sinai Hospital, New York, who presented the data at HRS. “The Globe System achieved outstanding freedom from atrial arrhythmia in both Paroxysmal and Persistent patients, with no device- or procedure-related major adverse events.

纽约西奈山医院的维韦克·雷迪博士（VivekReddy）在人力资源（HRS）上提供了这些数据。他说：“我对全球脉冲场系统的PULSE-EU研究结果感到非常兴奋。”全球系统在阵发性和持续性患者中均未出现房性心律失常，没有发生与设备或手术相关的重大不良事件。

These outcomes underscore the tremendous potential of the Globe System in advancing AF treatment and improving patient outcomes.”.

这些结果强调了Globe系统在推进房颤治疗和改善患者预后方面的巨大潜力。”。

The results demonstrated in the PULSE-EU study in patients receiving the optimized Pulsed Field (PF) dose included:

PULSE-EU研究显示，接受优化脉冲场（PF）剂量的患者的结果包括：

Durable Clinical Effectiveness:

持久的临床疗效：

Acute isolation was achieved in 100% of pulmonary veins (PVs).

100%的肺静脉（PVs）实现了急性隔离。

Freedom from atrial arrhythmia at 1 year was 84.2% in paroxysmal AF patients and 80% in persistent AF patients.

阵发性房颤患者1年无房性心律失常的发生率为84.2%，持续性房颤患者为80%。

Enhanced Procedural Safety:

增强程序安全性：

Zero device or procedure-related major adverse events (defined as death, phrenic nerve palsy, pericardial tamponade, pulmonary vein stenosis or esophageal complications)

零器械或手术相关的主要不良事件（定义为死亡、膈神经麻痹、心包填塞、肺静脉狭窄或食管并发症）

Efficient Procedural Workflow:

高效的程序工作流：

Average time to isolate all pulmonary veins was 23 minutes.

分离所有肺静脉的平均时间为23分钟。

True single-shot isolation with an average of just 1.2 PF applications per pulmonary vein.

真正的单次激发隔离，每个肺静脉平均仅应用1.2 PF。

Low average fluoroscopy time of only 5 minutes.

平均透视时间只有5分钟。

“These excellent results of the PULSE-EU Trial reflect Kardium’s ongoing dedication to develop the best treatment for Atrial Fibrillation”, said Kevin Chaplin, CEO of Kardium. “These findings highlight the potential of the Globe System to set new standards in the treatment of atrial fibrillation, with the potential to offer a safe and more effective therapeutic option for patients.

Kardium首席执行官凯文·卓别林（KevinChaplin）表示：“PULSE-EU试验的这些出色结果反映了Kardium一直致力于开发最佳的心房颤动治疗方法。”。“这些发现突显了Globe系统在治疗心房颤动方面制定新标准的潜力，有可能为患者提供安全有效的治疗选择。

Everyone at Kardium looks forward to further advancing our Globe technology and making it available to patients worldwide.”.

Kardium的每个人都期待着进一步推进我们的全球技术，并将其提供给全世界的患者。”。

About Kardium

关于Kardium

Kardium Inc. (kardium.com) is a rapidly growing, privately held medical solutions company that has developed an advanced system for atrial fibrillation (AF) treatment: the Globe System. Kardium has built an outstanding team, who have worked with top medical advisors to develop the Globe System. Founded in 2007 and headquartered in Vancouver, Canada, Kardium has consistently ranked as one of the top companies to work for in British Columbia..

Kardium Inc.（Kardium.com）是一家快速发展的私营医疗解决方案公司，开发了一种先进的心房颤动（AF）治疗系统：Globe系统。Kardium建立了一支杰出的团队，他们与顶级医学顾问合作开发了全球系统。Kardium成立于2007年，总部位于加拿大温哥华，一直是不列颠哥伦比亚省最值得工作的公司之一。。

This press release may contain forward-looking statements, which reflect current expectations regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, performance or achievements to be materially different from those expressed or implied by such statements.

本新闻稿可能包含前瞻性声明，反映了当前对未来事件的期望。这些前瞻性声明涉及风险和不确定性，可能导致实际结果、业绩或成就与此类声明明示或暗示的结果、业绩或成就存在重大差异。

The Globe System is restricted by federal law to investigational use only, and it has not been approved or cleared for commercial distribution in any jurisdictions..

Globe系统受联邦法律限制，仅用于研究用途，尚未在任何司法管辖区获得批准或批准用于商业分销。。