Approvals

Abbott has announced that the US Food and Drug Administration (FDA) has granted its clearance for the Assert-IQ insertable cardiac monitor (ICM), providing doctors with a new diagnostic option for the evaluation and long-term monitoring of people with irregular heartbeats.

The clearance adds to Abbott’s existing portfolio of connected medical devices, most of which aim to help doctors to manage and treat their patients remotely.

Unlike most available ICMs, which only work for a few years, the new Assert-IQ has two battery life options of at least three or six years, providing better flexibility for doctors to monitor their patients in a traditional or longer-term setting.

The device uses Bluetooth to connect to a transmitter – usually the patient’s mobile phone – where it then checks the patient’s heart rhythms every 20 seconds, transmitting the results in real time to the clinic’s portal. There is also an option for remote programming, meaning the clinician would be able to adjust the settings of the device, such as optimising performance and limiting any unnecessary transmissions remotely, which would reduce unnecessary clinic visits by the patient.

Dhanunjaya Lakkireddy MD, medical director of the Kansas City Heart Rhythm Institute, US, commented: “The Assert-IQ ICM is a significant advancement amongst the tools that are currently available for the diagnoses of irregular hear rhythms. Given that the device is small and is inserted just under the skin, patients can go about their daily lives, enjoying the activities that 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.”

Leonard Ganz MD, divisional vice president of medical affairs and chief medical officer of Abbott’s cardiac rhythm management business, added: “As the incidence of abnormal heart rhythms like atrial fibrillation continue to rise, more doctors are turning to UCM 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.”