FDA clears insertable cardiac monitor from Abbott

May 20, 2023  Source: drugdu 118

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Abbott (NYSE:ABT) today announced that it received FDA clearance for its Assert-IQ insertable cardiac monitor (ICM).
The Assert-IQ device offers a new option for diagnostic evaluation and long-term monitoring for irregular heartbeats. It supplements Abbott’s portfolio of connected health devices for managing and treating patients remotely. The device could potentially rival the Medtronic Linq system.
A small device with sensors inserted just under the skin of the chest, Assert-IQ provides constant, real-time monitoring. It can detect and identify arrhythmias that lead to symptoms like fainting, irregular pulse and shortness of breath. Abbott says many commercially available ICMs monitor hearts for “a few years,” but Assert-IQ offers two options. With a battery life of at least three or six years, it can provide doctors with a new level of flexibility in diagnostic monitoring.
The three-year option offers a method for more traditional monitoring. That includes diagnosing fainting, heart palpitations or abnormal heart rhythms. By offering at least six years of battery life, Abbott said Assert-IQ empowers physicians to monitor long-term. That can particularly help when caring for those undergoing therapy, or who have recently had a cardiac ablation procedure or may be at risk of developing further arrhythmias, such as AFib.
Both options utilize advanced algorithms to detect irregular heartbeats and provide clinically actionable data.
The Abbott Assert-IQ is ‘a significant advancement’ in heart monitoring
Dr. Dhanunjaya Lakkireddy called Assert-IQ “a significant advancement” among tools currently available for these purposes. Lakkireddy serves as medical director for the Kansas City Heart Rhythm Institute.
The system uses Bluetooth technology to remain connected to a transmitter — usually the person’s own cell phone. It checks heart rhythms every 20 seconds and transmits results in real time to the clinic’s portal. Some models in the Assert-IQ family have remote programming options, enabling clinicians to adjust settings. They can optimize performance and limit unnecessary alerts or transmissions, all without requiring the patient to visit the clinic.
“As the incidence of abnormal heart rhythms like atrial fibrillation continue 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, divisional VP 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.”

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