An insertable Bluetooth-enabled cardiac monitor offering the world’s longest battery life has been cleared for use in the US by the country’s Food and Drug Administration.
Global healthcare player Abbott’s Assert-IQ will give physicians a new option for diagnostic evaluation and long-term surveillance of people experiencing irregular heartbeats.
Known as arrhythmias, the heart can beat too slowly, too quickly, or irregularly. Symptoms can include palpitations, feeling dizzy, shortness of breath, and fainting. The condition can affect anyone of any age.
There are various types of arrhythmias, but atrial fibrillation, where the heart beats irregularly and faster than normal, is most common in people over the age of 60, mainly because older people are at increased risk of cardiovascular disease. They also often take medications that affect the heart’s rhythm.
Diagnosing irregular heartbeats can be challenging in many patients, however, as the problem can be fleeting.
ICMs – small devices with sensors that are inserted just under the skin of the chest – are designed to provide constant, real-time monitoring of a person’s heart to detect and identify arrhythmias that can lead to the most common symptoms.
While many commercially available ICMs monitor a person’s heart rhythms for a few years, Assert-IQ offers two options with a battery life of at least three or six years to provide doctors with a new level of flexibility in diagnostic monitoring.
Chicago headquartered Abbott says while the three-year option may be preferred for more traditional monitoring, such as diagnosing fainting, heart palpitations or detections of abnormal heart rhythms, an option offering at least six years of battery life empowers medical practitioners to monitor long-term.
This monitoring can be especially important when caring for people who are undergoing therapy, have recently had a cardiac ablation procedure or who are at risk of developing further arrhythmias, such as atrial fibrillation.
The US Food and Drug Administration has given clearance to the Assert-IQ ICM.
In both options, advanced algorithms are available to detect irregular heartbeats and provide clinically actionable data.
Dhanunjaya Lakkireddy, medical director of the Kansas City Heart Rhythm Institute, a world-renowned arrhythmia care facility, has described the Assert-IQ ICM as a “significant advancement” amongst the tools currently available for the diagnoses of irregular heart beats.
He said: “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.”
The device uses Bluetooth technology and is designed to remain connected to a transmitter – usually the person’s own smartphone – where it checks heart rhythms every 20 seconds, sending results in real-time to the clinic’s portal.
Additionally, some models of the Assert-IQ ICM family can be remotely programmed allowing the clinician to adjust the settings of the connected device, optimise performance and limit unnecessary alerts or transmissions – all without requiring the patient to make a clinic or hospital visit.
The Assert-IQ ICM also offers advanced diagnostic capabilities to provide medics with more clinically relevant information about the cardiovascular health of the patient, allowing them to make treatment decisions faster.
The Assert-IQ ICM is the latest addition to Abbott’s range of connected health devices, covering everything from cardiovascular products to diabetes care, diagnostics, neuromodulation, and nutrition. The company also has a portfolio of pharmaceuticals.
Leonard Ganz, divisional vice president of medical affairs and chief medical officer of Abbott’s cardiac rhythm management business, said: “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.
“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.”
