USA —Abbott has received approval from the U.S. Food and Drug Administration (FDA) for its Assert-IQ insertable cardiac monitor (ICM), which provides the longest battery life of any insertable cardiac monitor, lasting at least six years.
This device is designed for long-term monitoring of arrhythmias and utilizes Bluetooth technology to provide real-time readings to a patient’s clinician every 20 seconds.
The Assert-IQ ICM offers two battery options: a three-year battery for standard cases and a six-year battery for patients with a history of heart treatments or a high risk of arrhythmias.
The shorter-term option is suitable for patients needing monitoring to diagnose arrhythmias or cardiac symptoms, while the six-year option is designed for extended monitoring of diagnosed patients undergoing treatment or at risk of developing additional conditions.
Abbott highlights that the Assert-IQ devices can reach their designated battery life without compromising any of their features.
In comparison, Medtronic’s longest-lasting ICM, the Reveal Linq II, can last up to 4.5 years under “nominal settings” and drops to 2.5 years with app optimization enabled.
Like other ICMs on the market, including those from Abbott, Medtronic, and Boston Scientific, the Assert-IQ models are equipped with Bluetooth technology for wireless connectivity to smartphones or separate transmitters.
The implant sends heart rhythm readings to the connected device every 20 seconds, and the results are then transmitted to a clinician portal for review.
Furthermore, Abbott states that certain models of their newest loop recorder can be remotely programmed by doctors to adjust arrhythmia detection parameters based on a patient’s specific needs over time.
Dr. Leonard Ganz, Chief Medical Officer of Abbott’s cardiac rhythm management business, explained that as abnormal heart rhythms like atrial fibrillation become more prevalent, ICM technology is increasingly used to remotely monitor patients, aiding in the detection of symptoms that can impact overall health and quality of life.
The Assert-IQ implants utilize built-in algorithms to analyze heart rhythm data, automatically flagging potential cases of arrhythmia that might otherwise go unnoticed.
Study data presented last year demonstrates that the algorithms achieved over 96% sensitivity in detecting atrial fibrillation and tachycardia cases.
Additional clinical data cited by Abbott indicates that the Assert-IQ algorithms can reduce false detections of atrial fibrillation and ventricular pauses by more than 98% compared to ICMs without such algorithms for discriminating between heart rhythms.
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