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Abbott gets clearance from FDA for insertable cardiac monitor

Abbott has announced that its Assert-IQ insertable cardiac monitor (ICM) has received FDA clearance. This device presents a new option for diagnosing and monitoring irregular heartbeats in the long term. It complements Abbott’s range of connected health devices designed to remotely manage and treat patients, potentially competing with the Medtronic Linq system.

The Assert-IQ is a compact device with sensors implanted just below the skin on the chest, enabling continuous real-time monitoring. It effectively detects and identifies arrhythmias that can lead to symptoms like fainting, irregular pulse, and shortness of breath. While many available ICMs monitor heart activity for only a few years, the Assert-IQ offers two options with battery life lasting at least three or six years, providing physicians with greater flexibility in diagnostic monitoring.

The three-year option offers a more traditional monitoring approach, including the diagnosis of fainting, heart palpitations, or abnormal heart rhythms. On the other hand, the six-year battery life of the Assert-IQ empowers physicians to perform long-term monitoring, which is particularly beneficial for patients undergoing therapy, recent cardiac ablation procedures, or those at risk of developing further arrhythmias such as AFib.
Both options utilize advanced algorithms to detect irregular heartbeats and deliver clinically relevant data.

Dr. Dhanunjaya Lakkireddy, Medical Director of the Kansas City Heart Rhythm Institute, considers the Assert-IQ as a significant advancement among existing tools in this field.
The system incorporates Bluetooth technology to maintain a connection with a transmitter, often the patient’s own cell phone. It checks heart rhythms every 20 seconds and transmits real-time results to the clinic’s portal. Certain models within the Assert-IQ family offer remote programming options, enabling clinicians to make adjustments, optimize performance, and limit unnecessary alerts or transmissions, all without requiring the patient to visit the clinic.

With the rising incidence of abnormal heart rhythms like atrial fibrillation, more doctors are turning to ICM technology for remote patient monitoring to better detect underlying causes and manage symptoms that can impact overall health and quality of life. Dr. Leonard Ganz, Divisional VP of Medical Affairs and Chief Medical Officer of Abbott’s Cardiac Rhythm Management business, highlights the longevity factor, stating that until now, insertable cardiac monitors lacked the required lifespan for long-term monitoring. Abbott’s Assert-IQ ICM, a connected health device, equips physicians to deliver optimal care while making more accurate and informed treatment decisions.

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