July 1, 2021 — The U.S. Food and Drug Administration (FDA) has cleared the Angel Medical Systems Inc. second-generation AngelMed Guardian device.
Implantable Cardiac Monitor (ICM)
Implantable cardiac monitors (ICM) are small electrophysiology (EP) devices that used for long-term monitoring of a patient's heart electrical activity to detect arrhythmias. The technology can eliminate the need for a bulkly external Holter monitor that requires wire leads attached to the patient. ICMs can be inserted under the skin during and office visit and record cardiac data continuously for up to 4.5 years.
In the past decade there has been a proliferation of clinical-grade wearable monitors and implantable devices such as pacemakers, ICDs, implantable cardiac monitors, and new pacemaker-like devices that can control hypertension. In the near future, these devices will be tied into a body-wide internet of things for specific patients that can transmit patient data to clinicians wirelessly to enable an integrated, more robust form of telecardiology and telemedicine.
The FDA has cleared Angel Medical Systems' second-generation AngelMed Guardian device. The implantable cardiac device detects and warns patients if they are having an acute coronary syndrome (ACS) event, including silent heart attacks. The new, second-generation device is enhanced with ease-of-use adaptations and an updated, long life battery that could potentially double the life of the implanted device
Implicity provides a remote cardiac monitoring and research platform used by Independent Diagnostic Testing Facilities and medical centers to deliver high-quality care for patients with connected cardiac devices. On this platform, Implicity aggregates, normalizes and standardizes data from any implantable cardiac device across all manufacturers.
A device programmer showing the suspension of ICD therapies (orange bar, red arrow) with iPhone 12 laying over patient’s chest (green arrow) and fluoroscopy of iPhone 12 showing the circular magnet array (yellow arrow). Image from a small study at Henry Ford Hospital. Read the full study
Integrating data from an array of implantable EP devices from different vendors can be difficult or require disconnected silos of data for different vendors. One solution that was recently introduced to integrate data from various vendors is the Optimize EP software, which allows viewing data from all device vendors in one platform to streamline workflows.
The Linq II implantable cardiac monitor (ICM) system delivers improved device longevity compared to other ICMs and enhanced accuracy to correctly detect abnormal heart rhythms, simplifying the diagnosis and monitoring of patients. The new devices allows continuous cardiac monitoring for up to 4.5 years.