The US Food and Drug Administration (FDA) has approved Abbott’s Assert-IQ insertable cardiac monitor (ICM) device.
The new device will enable physicians to carry out diagnostic assessments and long-term monitoring of individuals with irregular heartbeats (arrhythmias).
Assert-IQ provides doctors with enhanced flexibility in diagnostic monitoring by offering two battery life options, ensuring a minimum lifespan of three or six years.
The three-year option is suitable for traditional monitoring such as diagnosis of fainting, heart palpitations or detection of abnormal heart rhythms. In contrast, the six-year option enables physicians to conduct long-term monitoring.
The monitoring is crucial for individuals who are undergoing therapy, have been recently treated for cardiac ablation or are vulnerable to additional arrhythmias including atrial fibrillation.
Abbott’s cardiac rhythm management business chief medical officer and medical affairs divisional vice-president Dr Leonard Ganz said: “Until now, insertable cardiac monitors have allowed for remote monitoring of patients but lacked the longevity needed to monitor them long-term.
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“Abbott’s Assert-IQ ICM offers physicians a connected health device that will help them provide the best care for their patients while making more accurate and informed treatment decisions.”
The Assert-IQ ICM utilises Bluetooth technology to stay connected to a transmitter, which is generally the individual’s personal mobile phone. It continuously monitors heart rhythms at 20-second intervals and transmits the real-time results to the clinic’s portal.
Furthermore, certain models within the Assert-IQ ICM family support remote programming to improve connectivity with patients.
This feature enables clinicians to modify the settings of the connected device, enhancing performance and minimising unnecessary alerts or transmissions.