第一个智能手机兼容的可插入心脏监护仪获得FDA批准

确认RX ICM允许患者通过蓝牙连接到他们的手机进行远程监控  Abbott SJM St. Jude确认RX植入式心脏监护仪(ICM)。雅培确认RX植入式心脏监测器(ICM)小于计算机拇指驱动器,并且植入在皮肤下的简单办公室程序中。

2017年10月23日 – 美国食品和药物管理局(FDA)已经清除了雅培的确认接收可插入心脏监测仪(ICM),这是世界上第一款智能手机兼容ICM,旨在帮助医生远程识别心律失常。该技术为美国患者提供了一种监测异常心律的新方法,同时远程连接到医生,并能够进行医疗保健。

雅培心律管理公司部门副总裁兼医疗总监Avi Fischer博士说:“确认Rx显示了我们能够采用先进的通信技术和最先进的医疗设备,为改善患者护理提供新的机会。“通过提供从患者智能手机使用蓝牙®无线技术的设备,我们可以帮助医生轻松远程诊断潜在的危险异常心脏跳动,而不需要患者使用单独的或繁琐的记录设备。

雅培可插入的心脏监护仪已经帮助医师远程监测患者的异常心律。通过纳入蓝牙无线技术,雅培已经通过允许患者通过myMerlin移动应用将他们的ICM连接到智能手机进行了远程监控。一旦在快速,微创的门诊手术过程中一次植入胸部皮肤下,确认Rx会持续监测心律,以检测心律失常的范围,包括不规则的心跳或房颤(AF或Afib)。

然后由设备收集的数据通过移动应用程序以诊所设置的时间表安全地传送给患者的医生。该应用程序还允许患者从自己的智能手机记录症状事件,而不需要额外的硬件,如手持激活器或床边发射器。

ICM可用于代替患者佩戴的Holter监护仪,特别适用于需要长期监测的患者。

确认Rx ICM的好处

确认Rx ICM是世界上第一个可插入心脏监测器,将快速和微创手术与使用蓝牙无线技术的设备相结合,允许患者使用下载到自己的智能手机的移动应用进行连接。

该设备和移动应用程序旨在允许:
•使用患者智能手机持续心脏监测记录不规则心跳事件。
•患者能够轻松地将心律信息发送给医生,而不会中断日常活动。
•一种谨慎的植入物 – 当今最小的可插入心脏监测器。

虽然确认Rx ICM持续监测异常心律,并将数据传输给患者的医生,myMerlin应用程序还允许患者主动跟踪症状,随时与其诊所同步其数据,并查看其传播历史,而无需与其接触诊所确认数据传输成功。

确认Rx ICM将通信限制在一个经过身份验证的myMerlin移动应用程序中。确认Rx ICM和myMerlin移动应用程序使用移动安全的最高标准加密所有无线通信。

St,Jude Medical(SJM)开发了确认RX。雅培1月份采购SJM。

欲了解更多信息:www.abbott.com

以上内容由Google翻译而来,原文如下:

First Smartphone Compatible Insertable Cardiac Monitor Cleared by FDA

Confirm RX ICM allows patients to be monitored remotely with a Bluetooth connection to their mobile phone

The Abbott Confirm RX implantable cardiac monitor (ICM) is smaller than a computer thumb-drive and in implanted in a simple in-office procedure just under the skin.

October 23, 2017 – The U.S. Food and Drug Administration (FDA) has cleared Abbott’s Confirm Rx Insertable Cardiac Monitor (ICM), the world’s first smartphone compatible ICM designed to help physicians remotely identify cardiac arrhythmias. The technology provides U.S. patients with a new way to monitor for abnormal heart rhythms while staying connected to their physician remotely and being able to engage in their healthcare.

“Confirm Rx shows what we can do with cutting edge communication technology and the most advanced medical devices that provide new opportunities to improve patient care,” said Avi Fischer, M.D., divisional vice president and medical director of Abbott’s cardiac rhythm management business. “By offering a device that uses Bluetooth® wireless technology from the patient’s smartphone, we can help physicians easily and remotely diagnose potentially dangerous abnormal heart beats without requiring the patient to use a separate or cumbersome recording device.”

Abbott’s insertable cardiac monitors have helped advance how physicians remotely monitor patients for abnormal heart rhythms. By incorporating Bluetooth wireless technology, Abbott has advanced remote monitoring by allowing patients to connect their ICM to their smartphone via the myMerlin mobile app. Once implanted just under the skin in the chest during a quick, minimally invasive outpatient procedure, the Confirm Rx continuously monitors heart rhythms to detect a range of cardiac arrhythmias, including irregular heartbeats or atrial fibrillation (AF or Afib).

Data collected by the device is then securely transmitted to a patient’s physician via the mobile app on a schedule set by the clinic. The app also allows patients to record symptomatic events from their own smartphone without the need for additional hardware such as handheld activators or bedside transmitters.

The ICM can be used in place of a a patient-worn Holter monitor, especially for patient requiring long-term monitoring.

Benefits of the Confirm Rx ICM

The Confirm Rx ICM is the world’s first insertable cardiac monitor that combines a quick and minimally invasive procedure with a device that uses Bluetooth wireless technology, allowing patients to connect using a mobile app downloaded to their own smartphone.

The device and mobile app are designed to allow for:
• Continuous heart monitoring using the patient’s smartphone to record episodes of irregular heartbeat.
• The ability for patients to easily send their heart rhythm information to their doctor without interrupting daily activities.
• A discreet implant—the slimmest insertable cardiac monitor available today.

While the Confirm Rx ICM continuously monitors for abnormal heart rhythms and transmits data to a patient’s physician, the myMerlin app also allows patients to track symptoms proactively, sync their data with their clinic at any time, and view their transmission history without having to contact their clinic to confirm successful data transfers.

The Confirm Rx ICM limits communication to a single authenticated myMerlin mobile app. The Confirm Rx ICM and the myMerlin mobile app encrypt all wireless communications using the highest standards in mobile security.

St, Jude Medical (SJM) developed the Confirm RX. Abbott Purchased SJM in January.