Abbott has launched a new implantable heart monitor, dubbed Confirm Rx, for the detection of arrhythmias in the US and Europe.
Confirm Rx holds US Food and Drug Administration (FDA) clearance and the European CE-Mark.
The paperclip-sized, next-generation insertable cardiac monitor (ICM) features smartphone connectivity and continuous, remote monitoring of irregular heartbeats to enable quick diagnosis.
Arrhythmia is characterised by abnormal heart rhythm, which could result in symptoms such as the feeling of the heart racing, dizziness, shortness of breath or fainting.
The company noted that majority of the patients suffering with the most common form of arrhythmia called atrial fibrillation (AFib) are not even aware of their condition.
Existing wearables to monitor cardiac arrhythmias have their limitations. Many require recharging while others require human interventions to record symptoms, thereby affecting clinical diagnosis.
Confirm Rx is designed to help physicians remotely and continuously monitor arrhythmias in people who are at most risk. The device is implanted under the skin in the chest above the heart in a minimally invasive outpatient procedure.
It can be connected to a smartphone via Bluetooth in order to transmit information to the physician. The mobile app eliminates the requirement for an additional transmitter.
Abbott Cardiac Rhythm Management therapies medical director Avi Fischer said: “Through new advances like Abbott’s next generation of Confirm Rx ICM, physicians can act more proactively and efficiently in their treatment approach, and patients can stay engaged and connected.”
The detection technology in the new device minimises false detection by 97% and does not notify physicians of irregular heartbeats that may not be related to an arrhythmia.
The device’s SharpSense technology has been designed based on physician feedback and user insights.