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) using pulsed field ablation (PFA), announced today the successful completion of enrollment in the paroxysmal cohort of the pivotal PULSAR IDE (Investigational Device Exemption) study.

不列颠哥伦比亚省温哥华市——（商业新闻短讯）——Kardium Inc.，一家私人医疗器械公司，开发了使用脉冲场消融（PFA）治疗心房颤动（AF）的Globe®系统，今天宣布成功完成关键脉冲星IDE（研究设备豁免）研究阵发性队列的注册。

This achievement marks a significant milestone in the journey to bring this groundbreaking technology to patients in the United States, with data from the study to be submitted to the Food and Drug Administration (FDA) for Pre-Market Approval (PMA)..

这项成就标志着将这项开创性技术带给美国患者的旅程中的一个重要里程碑，该研究的数据将提交给美国食品和药物管理局（FDA）进行上市前批准（PMA）。。

The PULSAR IDE study, an international, multi-center clinical trial, is designed to evaluate the safety and effectiveness of the Globe System for the treatment of atrial fibrillation. The successful completion of enrollment underscores the commitment of the clinical sites, investigators, and the entire Kardium team..

PULSAR IDE研究是一项国际多中心临床试验，旨在评估Globe系统治疗心房颤动的安全性和有效性。成功完成注册突显了临床现场，研究人员和整个Kardium团队的承诺。。

“Reaching this milestone is a significant achievement,' said Dr. Vivek Reddy of Mount Sinai Hospital, New York, co-principal investigator of the PULSAR study. 'The Globe System provides precise control over the ablation, enhancing our potential to improve patient safety and treatment outcomes. By integrating mapping and ablation into a single catheter, its design streamlines workflow.'.

“达到这一里程碑是一项重大成就，”纽约西奈山医院的维韦克·雷迪博士（PULSAR研究的联合首席研究员）说。“Globe系统提供了对消融的精确控制，增强了我们改善患者安全和治疗结果的潜力。通过将映射和消融整合到单个导管中，其设计简化了工作流程。”。

Dr. Atul Verma from McGill University Health Centre, Montreal, and co-principal investigator said, 'The ability of the Globe System to deliver PF energy precisely to the area of interest stands out as a key differentiator. Its innovative design enhances our confidence in the durability of the ablation and our ability to improve patient safety.”.

蒙特利尔麦吉尔大学健康中心（McGill University Health Center，Montreal）的Atul Verma博士和联合首席研究员说，“全球系统将PF能量精确输送到感兴趣的领域的能力是一个关键的区别。它的创新设计增强了我们对消融耐久性的信心，增强了我们提高患者安全性的能力。”。

Kevin Chaplin, CEO of Kardium, expressed his gratitude to the patients, study investigators, and team members whose efforts have made this achievement possible. 'The completion of enrollment in the PULSAR study represents a major accomplishment for Kardium. It moves us closer to our goal of transforming the treatment for patients with atrial fibrillation worldwide.

Kardium首席执行官凯文·卓别林（KevinChaplin）对患者、研究人员和团队成员表示感谢，他们的努力使这一成就成为可能完成PULSAR研究的注册代表了Kardium的一项重大成就。它使我们更接近我们的目标，即改变全球房颤患者的治疗方法。

We are committed to working closely with the FDA during the PMA submission process to bring this state-of-the-art technology to the market.'.

我们致力于在PMA提交过程中与FDA密切合作，将这种最先进的技术推向市场。”。

As the PULSAR study progresses toward its final stages, Kardium remains dedicated to its mission of developing a complete solution for the treatment of atrial fibrillation and improving patient care. The company eagerly anticipates the potential to improve the lives of millions of patients worldwide suffering from atrial fibrillation..

随着PULSAR研究进入最后阶段，Kardium仍致力于开发治疗心房颤动的完整解决方案和改善患者护理的使命。该公司热切期望能够改善全球数百万患有心房颤动的患者的生活。。

The Globe System features the revolutionary Globe Catheter with 122 gold electrodes, each of which can map the patient’s cardiac anatomy and electrical activity and deliver pulsed field energy to the heart. The Globe Catheter sensors are used to create a proprietary CONTACT™ Map to identify electrodes in contact with cardiac tissue, helping to confirm the delivery of therapy..

Globe系统的特点是具有122个金电极的革命性球形导管，每个电极都可以绘制患者的心脏解剖结构和电活动，并将脉冲场能量传递给心脏。球形导管传感器用于创建专有的CONTACT™地图，以识别与心脏组织接触的电极，帮助确认治疗的实施。。

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。。