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FDA approves Abbott’s insertable cardiac monitor for long-term monitoring of arrhythmia

US pharmaceutical and healthcare major Abbott has recently announced that US Food and Drug Administration (FDA) has authorised its Assert-IQ insertable cardiac monitor (ICM) for long-term monitoring and diagnostic assessment of patients with irregular heartbeats.

In a statement, the company informed that the authorisation would provide the doctors with a new diagnostic tool for managing arrhythmia patients more efficiently and adds to Abbott's long line-up of remote patient management and treatment tools.

Assert-IQ distinguishes itself from other commercially available implantable cardiac monitors (ICMs) by providing two options for ICMs that can continuously measure heart rhythms for three or six years. Clinicians prefer the standard three-year option to assess disorders such as heart palpations and arrhythmic patterns, while those requiring devices with extended battery lives choose ones with at least six years, according to the statement.

The statement further noted that Patients undergoing treatment, recent cardiac ablation patients, and those at risk of developing new arrhythmias require especially crucial arrhythmia, including  Atrial fibrillation during their treatment. 

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Commenting on the device, Dr Dhanunjaya Lakkireddy, the medical director of the Kansas City Heart Rhythm Institute said, “The Assert-IQ ICM is a significant advancement amongst the tools that are currently available for the diagnoses of irregular heart rhythms. Given that the device is small and is inserted just under the skin, patients can go about their daily lives, enjoying the activities they love, and the ICM does the work.”

“With Assert-IQ ICM's advanced algorithms, it can detect even hard-to-spot irregularities and help physicians determine a treatment course. It can be a very valuable tool both for short-term and long-term management of cardiac arrhythmia disorders,” he added.

The device uses Bluetooth technology and is designed to remain connected to a transmitter, usually, the person's cell phone, where it checks heart rhythms every 20 seconds, transmitting results in real-time to the clinic's portal, while some models can be remotely configured, allowing the clinician to alter the parameters of the connected device, optimise performance, and minimise unnecessary warnings or transmissions, without having the patient to visit the doctor’s clinic.

“As the incidence of abnormal heart rhythms like atrial fibrillation continues to rise, more doctors are turning to ICM technology to monitor their patients remotely to better detect the cause of symptoms that can impact overall health and quality of life,” said Dr Leonard Ganz, the divisional vice president of medical affairs and chief medical officer of Abbott's cardiac rhythm management business. 

"Until now, insertable cardiac monitors have allowed for remote monitoring of patients but lacked the longevity needed to monitor them long-term. 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,” he added. 

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