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Abbott Receives Fda Clearance For Assert-iq™ Insertable Cardiac Monitor To Help Doctors Monitor People's Heart Rhythms Long-term

Friday, May 19, 2023

Abbott's Assert-IQ™ Insertable Cardiac Monitor Receives FDA Clearance for Remote Heart Monitoring

Abbott has announced that its innovative Assert-IQ™ insertable cardiac monitor (ICM) has received clearance from the U.S. Food and Drug Administration (FDA). This groundbreaking development provides physicians with a new and effective option for diagnostic evaluation and long-term monitoring of individuals experiencing irregular heartbeats. The FDA clearance strengthens Abbott's portfolio of connected health devices, empowering doctors to manage and treat their patients remotely.

Irregular heartbeats, also known as arrhythmias, can be fleeting and pose challenges for accurate diagnosis. ICMs, which are small devices with sensors inserted just beneath the skin of the chest, are designed to offer continuous, real-time monitoring of the heart. They detect and identify arrhythmias that can lead to symptoms such as fainting, irregular pulse, and shortness of breath.

While many existing ICMs monitor heart rhythms for a few years, the Assert-IQ introduces two options with battery lives of at least three or six years. This flexibility provides physicians with enhanced diagnostic monitoring capabilities. The three-year option is well-suited for traditional monitoring, such as diagnosing fainting, heart palpitations, or detecting abnormal heart rhythms. On the other hand, the option offering at least six years of battery life enables long-term monitoring, which is particularly valuable for individuals undergoing therapy, recent cardiac ablation procedures, or at risk of developing further arrhythmias like atrial fibrillation. In both options, advanced algorithms are employed to detect irregular heartbeats and provide actionable clinical data.

Dhanunjaya Lakkireddy, M.D., medical director of the Kansas City Heart Rhythm Institute, praises the Assert-IQ ICM as a significant advancement in diagnosing irregular heart rhythms. Its small size and subcutaneous placement allow patients to continue their daily lives without disruption while the ICM diligently monitors their heart. The device's advanced algorithms can detect even subtle irregularities, assisting physicians in determining the appropriate treatment course. It proves to be an invaluable tool for short-term and long-term management of cardiac arrhythmia disorders.

Utilizing Bluetooth® technology, Abbott's Assert-IQ ICM remains connected to a transmitter, typically the patient's own cell phone. It continuously checks heart rhythms every 20 seconds and transmits real-time results to the clinic's portal. Certain models within the Assert-IQ ICM family can be remotely programmed, allowing clinicians to adjust device settings, optimize performance, and limit unnecessary alerts or transmissions—all without requiring in-person visits from the patient.

The Assert-IQ ICM also offers advanced diagnostic capabilities, equipping physicians with clinically relevant information about patients' cardiovascular health. This empowers care providers to make faster, more informed clinical decisions.

Leonard Ganz, M.D., divisional vice president of medical affairs and chief medical officer of Abbott's cardiac rhythm management business, highlights the rising incidence of abnormal heart rhythms like atrial fibrillation. As a result, more doctors are turning to ICM technology for remote patient monitoring, enabling them to better detect the underlying causes of symptoms that can significantly impact overall health and quality of life. Until now, insertable cardiac monitors lacked the necessary longevity for long-term monitoring. Abbott's Assert-IQ ICM bridges this gap, providing physicians with a connected health device that facilitates exceptional patient care while enabling more accurate and informed treatment decisions.

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