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Acutus Medical Initiates First IDE Therapy Trial with the AcQBlate® FORCE Sensing Ablation System</h2><h2>Acutus Medical首次使用AcQBlate®力感消融系统进行IDE治疗试验

AcQBlate FORCE Sensing Ablation System

蓄能力传感烧蚀系统

A complete ablation system which includes the smallest footprint of any RF Generator and is comprised of four components: Qubic RF controller, Qubic Force Module, Qubic RF Generator and Qiona Irrigation pump.A complete ablation system which includes the smallest footprint of any RF Generator and is comprised of four components: Qubic RF controller, Qubic Force Module, Qubic RF Generator and Qiona Irrigation pump.AcQBlate FORCE Sensing Ablation Catheter

一个完整的烧蚀系统,包括最小的射频发生器,由四个组件组成:Qubic射频控制器,Qubic力模块,Qubic射频发生器和Qiona灌溉泵。一个完整的烧蚀系统,包括最小的射频发生器,由四个组件组成:Qubic射频控制器,Qubic力模块,Qubic射频发生器和Qiona灌溉泵。acqublate FORCE Sensing消融导管

AcQBlate FORCE: the first and only force sensing ablation catheter with a gold-tip electrode.AcQBlate FORCE: the first and only force sensing ablation catheter with a gold-tip electrode.

AcQBlate FORCE:第一个也是唯一一个带有金尖电极的力感应消融导管。AcQBlate FORCE:第一个也是唯一一个带有金尖电极的力感应消融导管。

CARLSBAD, Calif., April 05, 2021 (GLOBE NEWSWIRE) -- Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced initial US enrollments in the company’s AcQForce™ Flutter Investigational Device Exemption (IDE) clinical trial. This trial is expected to enroll up to 150 subjects in leading centers globally and will evaluate the safety and efficacy of the AcQBlate FORCE sensing ablation catheter and system in the treatment of Right Atrial Typical Flutter. In the US, Right Atrial Typical Flutter ablation procedures currently account for approximately 30% of cardiac ablations and are expected to reach 200,000 annually by 20251.

Acutus Medical (Nasdaq: AFIB)是一家心律失常管理公司,专注于改善心律失常的诊断和治疗方式。该试验预计将在全球领先中心招募150名受试者,并将评估AcQBlate力感消融导管和系统治疗右心房典型扑动的安全性和有效性。在美国,右心房典型扑动消融术目前约占心脏消融术的30%,预计到20251年每年将达到20万例。

In contrast to the most contemporary ablation systems, AcQBlate FORCE can operate both in a stand-alone manner or in conjunction with a compatible 3D mapping system. The AcQBlate FORCE sensing ablation system is comprised of Acutus’ AcQBlate FORCE catheter and Qubic Force module that seamlessly integrates an RF generator and irrigation pump. The complete AcQBlate FORCE sensing ablation catheter and system, which received full CE Mark in late 2020, is now commercially available in Europe through our Acutus direct organization and our partner BIOTRONIK.

与大多数当代消融系统相比,AcQBlate FORCE既可以独立运行,也可以与兼容的3D绘图系统结合运行。AcQBlate力感测消融系统由Acutus公司的AcQBlate力导管和Qubic力模块组成,Qubic力模块无缝集成了射频发生器和灌溉泵。完整的AcQBlate力感消融导管和系统,于2020年末获得了完整的CE标志,现在通过我们的Acutus direct组织和我们的合作伙伴BIOTRONIK在欧洲上市。

Designed specifically to provide consistent, effective therapeutic solutions during cardiac ablation procedures, the AcQBlate FORCE system shows physicians, in real-time, how much contact force is being applied to the heart during ablations. Studies have shown the utility of real-time contact force information in helping physicians guide safe and effective therapy, which may improve patient outcomes2.

专为在心脏消融过程中提供一致、有效的治疗方案而设计的AcQBlate FORCE系统实时向医生显示消融过程中有多少接触力被施加到心脏上。研究表明,实时接触力信息可以帮助医生指导安全有效的治疗,这可能会改善患者的预后。

“The AcQBlate FORCE sensing ablation catheter provides stable contact force readings with low fluid irrigation requirements. It displayed both easy maneuverability and excellent stability during atrial ablation. I look forward to further evaluating this system and believe this technology has the potential to improve patient outcomes,” said Dr. Gery Tomassoni of Baptist Health Medical Group in Lexington, Ky., who performed the first case in the trial.

AcQBlate力感测消融导管提供稳定的接触力读数,且对液体冲洗的要求较低。在房颤消融过程中表现出易操作和良好的稳定性。我期待着进一步评估这一系统,并相信该技术有潜力改善患者的治疗结果。”他主持了第一个案件的审判。

Dr. Sean Beinart of Adventist Healthcare White Oak Medical Center in Silver Springs, Md. further commented, “the system was very easy for our lab staff to set up, and we were able to complete the case without changing our existing workflow. As the incidence of atrial arrhythmias increases, we continue to look for safe, effective and efficient treatment options for patients. The AcQBlate FORCE sensing ablation catheter incorporates a gold-tipped electrode that is designed for efficient energy delivery and effective lesion creation in less time.”

马里兰州银泉市基督复临医疗保健白橡树医疗中心的Sean Beinart博士进一步评论道:“我们的实验室工作人员建立该系统非常容易,我们能够在不改变现有工作流程的情况下完成病例。随着房性心律失常发生率的增加,我们继续为患者寻找安全、有效和高效的治疗方案。AcQBlate力感消融导管包含了一个金头电极,旨在在更短的时间内实现高效的能量传递和有效的病灶产生。”

“This trial represents our initial entry into the United States with a therapeutic technology for the treatment of atrial arrhythmias,” said Vince Burgess, CEO of Acutus Medical. “The gold-tipped AcQBlate FORCE catheter is a state-of-the-art ablation device that is paired with our laser-based contact force console and further integrated with the smallest and most modern RF generator and pump available. As we have experienced in our European centers during our initial market release, when used in concert with our novel AcQMap 3D mapping system we are seeing highly efficient workflow and operational efficiency. We look forward to offering the benefits of a comprehensive, force sensing ablation system to electrophysiologists and patients in the United States once we complete clinical trials and gain regulatory approval.”

Acutus Medical的首席执行官Vince Burgess说:“这项试验代表了我们首次将治疗技术引入美国,用于治疗心房性心律失常。”“gold-tip AcQBlate FORCE导管是一种最先进的消融设备,与我们基于激光的接触力控制台配对,并进一步集成到最小、最现代的射频发生器和泵。正如我们在欧洲中心首次市场发布时所经历的那样,当与我们新颖的AcQMap 3D地图系统一起使用时,我们看到了高效的工作流程和运营效率。一旦我们完成临床试验并获得监管部门批准,我们期待为美国的电生理学家和患者提供一个全面的、力感消融系统。”

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