Abbott (NYSE: ABT) today announced it has received CE Mark in Europe for the Volt™ PFA System to treat patients battling atrial fibrillation (AFib). With the earlier-than-expected CE Mark, Abbott has begun commercial PFA cases in the EU with physicians who have already gained experience with the Volt PFA System within Abbott's PFA clinical studies. The company will further expand use of Volt in EU markets throughout the second half of the year.

雅培 (NYSE: ABT) 今天宣布，其用于治疗心房颤动 (AFib) 患者的 Volt™ PFA 系统已在欧洲获得 CE 标志。凭借早于预期的 CE 标志，雅培已开始在欧盟开展商业 PFA 案例，其合作医生已在雅培的 PFA 临床研究中积累了使用 Volt PFA 系统的经验。该公司将在下半年进一步扩大 Volt 在欧盟市场的使用。

Today, approximately 8 million Europeans over the age of 65 are living with AFib, a number expected to double over the next 30 years.

如今，约有 800 万 65 岁以上的欧洲人患有房颤，预计在未来 30 年内这一数字将翻一番。

People living with AFib face an increased risk of stroke, heart failure and death, and many rely on cardiac ablation to treat the condition effectively. The Volt PFA System builds upon Abbott's leading electrophysiology (EP) portfolio by providing a single-catheter PFA approach, improving workflow by allowing for mapping, pacing, and ablating with a single catheter to safely and effectively treat patients with AFib..

房颤患者面临更高的中风、心力衰竭和死亡风险，许多患者依赖心脏消融术来有效治疗该疾病。Volt PFA系统基于Abbott领先的电生理学（EP）产品组合，提供了一种单导管PFA方法，通过允许使用单根导管进行标测、起搏和消融，改善了工作流程，从而安全有效地治疗房颤患者。

CE Mark approval for the Volt PFA System was granted based on strong results from

基于强有力的结果，Volt PFA系统获得了CE标志批准。

Abbott's Volt CE Mark study

雅培的Volt CE标志研究

, a global clinical trial conducted at centers in. The trial showed the Volt PFA System achieved pulmonary vein isolation (PVI) – the method of destroying tissue causing a patient's AFib – in 99.1% of veins during ablation procedures with far fewer energy applications than on-market competitive PFA systems.

，一项在全球多个中心开展的临床试验显示，Volt PFA系统在消融手术中实现了99.1%的肺静脉隔离（PVI）——这是一种通过破坏组织来治疗患者房颤的方法，并且与市场上其他竞争性PFA系统相比，使用的能量应用次数要少得多。

Following approval, initial cases were completed by Prof. Helmut Puererfellner at Ordensklinikum hospital in Linz,

在获得批准后，最初的病例由林茨Ordensklinikum医院的赫尔穆特·普尔费尔纳教授完成，

'The launch of Abbott's Volt PFA system marks a major milestone in the evolution of electrophysiology across

“雅培的Volt PFA系统的推出标志着电生理学发展的一个重要里程碑，

and signals we're moving beyond early therapy approaches to new systems that incorporate key physician feedback and clinical insights to optimize PFA therapy,' said Prof. Puererfellner. 'PFA is significantly changing our approach to treating patients and it's exciting to see the Volt PFA System build on the therapy's potential and bring new benefits to clinical teams so we can improve the lives of more patients battling conditions like AFib.'.

普勒费尔纳教授表示：“信号表明我们正在超越早期的治疗方法，转向整合了关键医生反馈和临床见解的新系统，以优化PFA治疗。PFA正在显著改变我们治疗患者的方式，令人兴奋的是，Volt PFA系统在这一疗法的潜力基础上进一步发展，并为临床团队带来新的益处，从而帮助更多患有房颤等疾病的患者改善生活。”

Volt™ PFA System: Driving New Advancement in the PFA Market

Volt™ PFA系统：推动PFA市场的新发展

PFA works differently from traditional ablation approaches by delivering high energy electrical pulses to targeted areas of cardiac tissue causing abnormal heart rhythms. As a result, PFA can reduce the risk of damaging adjacent tissue in patients with complex disease or anatomy.

PFA 与传统消融方法不同，它通过向心脏组织的特定区域传递高能量电脉冲来处理异常心律。因此，PFA 可以降低复杂疾病或解剖结构患者中损坏邻近组织的风险。

Yet current on-market competitive PFA systems have required several therapy applications with a catheter positioned in various locations due to a lack of visualization or contact assessment. By integrating with Abbott's EnSite™ X EP system, the Volt PFA System is designed to address such limitations and provide:.

然而，目前市场上的竞争性PFA系统由于缺乏可视化或接触评估，通常需要在不同位置进行多次导管治疗。通过与雅培的EnSite™ X EP系统集成，Volt PFA系统旨在解决这些限制并提供：

Simplified workflow

简化的工作流程

. The single-catheter integrated approach of the Volt PFA system improves clinical workflow and provides real-time contact visualization to help physicians position the catheter for therapy delivery.

Volt PFA系统的单导管集成方法改进了临床工作流程，并提供实时接触可视化，帮助医生定位导管以进行治疗输送。

Efficient energy delivery

高效的能量传递

. The proprietary balloon-in-basket design of the Volt™ PFA Catheter, Sensor Enabled™, allows for efficient energy transfer directly to the targeted tissue to stop the heart's erratic signals, minimizing the number of therapy applications needed.

Volt™ PFA 导管（支持传感器）的专有篮内球囊设计允许将能量高效传递到目标组织，以阻止心脏的紊乱信号，从而减少所需治疗次数。

Procedural flexibility

程序灵活性

. Patients undergoing a minimally invasive ablation procedure with the Volt PFA Catheter, Sensor Enabled, can be placed under light sedation or general anesthesia based on physician and hospital preference.

使用Volt PFA导管（传感器启用）进行微创消融手术的患者，可以根据医生和医院的偏好选择轻度镇静或全身麻醉。

In addition, the Volt PFA catheter's integration with EnSite X system allows for clearer visualization and navigation for accurate positioning of the Volt PFA catheter to treat tissue. The One System Solution provided by EnSite X can accommodate all EP procedures and compatible technologies.

此外，Volt PFA 导管与 EnSite X 系统的整合能够更清晰地显示和导航，以精确放置 Volt PFA 导管来治疗组织。EnSite X 提供的单一系统解决方案可以适应所有电生理（EP）手术和兼容技术。

'While PFA is a relatively new therapy option, we've incorporated lessons learned from first-generation devices and designed the Volt system to simplify PFA procedures while making them more efficient,' said

“虽然PFA是一种相对较新的治疗选择，但我们借鉴了第一代设备的经验，并设计了Volt系统以简化PFA手术流程，同时提高其效率，”

Christopher Piorkowski

克里斯托弗·皮奥科夫斯基

, M.D., chief medical officer of Abbott's electrophysiology business. 'Clinical data has also shown that the Volt catheter's cutting-edge design helps physicians achieve pulmonary vein isolation in fewer ablation attempts and less therapy applications for improved patient outcomes.'

医学博士，雅培电生理业务首席医疗官。“临床数据还表明，Volt导管的尖端设计有助于医生在更少的消融尝试和更少的治疗应用下实现肺静脉隔离，从而改善患者的治疗效果。”

Clinical and Regulatory Progress Across Abbott's PFA Portfolio

雅培PFA产品组合的临床和监管进展

Abbott's Volt PFA System is currently under evaluation in the

雅培的Volt PFA系统目前正在评估中

VOLT-AF Investigational Device Exemption

VOLT-AF 试验性器械豁免

(IDE) Study. The study completed enrollment last year – four months ahead of the anticipated timeline. Nearly 400 patients are enrolled in the trial, and Abbott anticipates completing the 12-month follow-up for the study later this year.

（IDE）研究。该研究去年完成了入组，比预期时间提前了四个月。近400名患者参加了试验，Abbott预计在今年晚些时候完成该研究的12个月随访。

In addition, the company has also made significant progress in

此外，该公司还取得了显著的进展

clinical studies

临床研究

evaluating Abbott's focal PFA technology, which is designed to provide focused energy delivery for the creation of targeted lesions at specific points in the heart. Enrollment was recently completed ahead of schedule in Abbott's FOCALFLEX CE trial assessing the performance of the TactiFlex™ Duo Ablation Catheter, Sensor Enabled™.

评估雅培的局灶性脉冲场消融（PFA）技术，该技术旨在为心脏特定位置的靶向病灶创建提供聚焦能量输送。雅培最近提前完成了FOCALFLEX CE试验的入组工作，该试验评估了TactiFlex™ Duo 消融导管（传感器启用™）的性能。

Enrollment is also underway in the FlexPulse IDE trial evaluating TactiFlex Duo in the U.S..

FlexPulse IDE试验也正在美国进行中，评估TactiFlex Duo。

Abbott has also recently received regulatory approval in the U.S. and

Abbott 近期还获得了美国的监管批准，并且

Europe

欧洲

for a 13F sizing of the company's Agilis™ NxT Steerable Introducer, Dual Reach™, which makes the Agilis system compatible with larger catheters, including those used for PFA therapy.

对于公司Agilis™ NxT可操控引入器、Dual Reach™的13F尺寸设计，这使得Agilis系统能够兼容更大的导管，包括那些用于PFA治疗的导管。

About Abbott

关于雅培

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries..

Abbott是一家全球医疗保健领域的领导者，帮助人们在生命的各个阶段更充实地生活。我们改变生命的技术组合涵盖了整个医疗保健领域，在诊断、医疗器械、营养品和品牌仿制药方面拥有领先的业务和产品。我们的114,000名员工服务于超过160个国家的人们。