Acutus医疗AcqMap心脏图谱技术获得FDA批准

Acutus医疗接受AcqMap心脏图谱技术的FDA清关

2017年10月24日 – Acutus Medical宣布美国食品和药物管理局(FDA)已经清除了AcQMap高分辨率成像和绘图系统和AcQMap 3-D成像和绘图导管,用于已经规定了电生理程序的患者。该公司计划在2018年初向美国客户推出初始商业系统。

AcQMap系统在过去两年在欧洲已经在许多临床试验和商业环境中被使用。使用DDRAMATIC-SVT试验的临床安全性结果来支持公司的510(k)清除率。

来自英国伦敦皇家布朗普顿医院的医生说:“我们非常高兴参加早期的临床工作,目前正在使用该技术作为患者特定战略的一部分来评估和治疗复杂的心律失常。” 。“该AcQMap系统能够提供不规则和混乱的激活全球偶极密度映射在心房腔室,而常规的顺序映射可能难以向我们提供所需的信息。在迄今为止我们已经进行的情况下,复杂心律失常的实时映射已经使我们能够关注感兴趣的领域,并使用消融治疗来终止心律失常。我们现在可以提供个性化,量身定制的疗法,并且更接近于确定复杂心律失常的机制。“

AcQMap高分辨率成像和绘图系统可以检测和显示基于标准电压和更高分辨率的偶极密度(电荷 – 源)图。AcQMap系统将超声解剖结构与将每个心跳的电传导映射到整个心房的复杂心律失常的能力相结合。在每次消融治疗后,可以在几秒钟内重新映射心脏,以便连续显现来自先前映射的任何变化。

在患者病例中观看系统的视频演示。

欲了解更多信息:www.acutusmedical.com

以上内容由Google翻译而来,原文如下:

Acutus Medical Receives FDA Clearance for AcQMap Cardiac Mapping Technology

Three-dimensional mapping system and accompanying catheter allow more detailed identification of complex arrhythmias

October 24, 2017 — Acutus Medical announced that the U.S. Food and Drug Administration (FDA) has cleared the AcQMap High Resolution Imaging and Mapping System and the AcQMap 3-D Imaging and Mapping Catheter for use in patients for whom electrophysiology procedures have been prescribed. The company plans to introduce initial commercial systems to U.S. customers in early 2018.

The AcQMap System has been used in Europe over the past two years in a number of clinical trials and commercial settings. Clinical safety results from the DDRAMATIC-SVT trial were used to support the company’s 510(k) clearance.

“We are extremely excited to have participated in the early clinical work and are now using the technology as part of a patient-specific strategy to assess and treat complex arrhythmias,” said Tom Wong, M.D., from the Royal Brompton Hospital in London, England. “The AcQMap System is able to provide global dipole density mapping of irregular and chaotic activation in the atrial chambers, whereas conventional sequential mapping may struggle to provide us with the information that is required. In the cases we have performed thus far, real-time mapping of complex arrhythmias has allowed us to focus on areas of interest and terminate the arrhythmia using ablation therapy. We can now offer individualized, tailored therapy, and are one step closer to identifying the mechanisms of complex arrhythmias.”

The AcQMap High Resolution Imaging and Mapping System detects and displays both standard voltage-based and higher resolution dipole density (charge-source) maps. The AcQMap System combines ultrasound anatomy construction with an ability to map the electrical-conduction of each heartbeat to identify complex arrhythmias across the entire atrial chamber. Following each ablation treatment, the heart can be re-mapped in seconds to continually visualize any changes from the prior mapping.