Abbott receieves CE Mark for its groundbreaking Assert-IQ insertable cardiac monitor

March 27, 2024
ABBOTT PARK, Ill., Mar. 25, 2024 — Abbott today announced it has received CE Mark in Europe for its Assert-IQ™ insertable cardiac monitor (ICM), offering physicians a new option for diagnostic evaluation and long-term monitoring of people experiencing abnormal heartbeats. Assert-IQ ICM is a new addition to Abbott's growing portfolio of connected health devices. It can detect even hard-to-spot irregularities with heartbeats and help physicians determine the best treatment course.

More than 33.5 million people globally have atrial fibrillation,1 the most common heart arrhythmia, and its prevalence is expected to increase over the next 30 years.2 Arrhythmias, or irregular heartbeats, can be fleeting, making them difficult to diagnose. Now, with a minimally invasive procedure, physicians can insert the small, thin Assert-IQ ICM under the skin of the chest to monitor a person's heart continuously and detect arrhythmias, which can lead to symptoms such as fainting and shortness of breath. After insertion, people can go about their daily lives while the ICM continuously monitors their heart.

Using Bluetooth technology, Abbott's Assert-IQ ICM is designed to connect to a transmitter —usually the person's own cell phone — where it checks heart rhythms every 20 seconds, transmitting important findings in virtually real-time to their clinic's portal. Assert-IQ offers the world's longest battery life for a Bluetooth-enabled ICM.

While many commercially available ICMs monitor a person's heart rhythm for a few years, Assert-IQ has two options, one with a battery life of at least three years and another with at least six years. The three-year option may be preferred for more traditional monitoring, such as diagnosing fainting or heart palpitations, or detections of abnormal heart rhythms, while the six-year option is designed for longer-term monitoring for those at risk of developing arrhythmias. Both options have advanced algorithms available to detect irregular heartbeats and provide clinically actionable data. Improved algorithms in Assert-IQ ICM reduce the data burden and increase the accuracy of the device, ultimately improving physician workflow and efficiency.

"As the prevalence of abnormal heart rhythms rise, physicians increasingly rely on ICM technology to diagnosis various heart conditions," said Leonard Ganz, M.D., divisional vice president of medical affairs and chief medical officer of Abbott's cardiac rhythm management business. "Introducing Assert-IQ in Europe will expand access to transformative benefits of long-term monitoring and more clinically relevant information, and allow care providers to make clinical decisions faster and with more precision."

Having pioneered the introduction of the world's first Bluetooth®-enabled ICM, Abbott is leading innovation once more in arrhythmia management with Assert-IQ ICM. The latest device provides consistent monitoring for abnormal heart rhythms while offering tools designed to improve data management and workflow.

"Assert-IQ is the next generation of implantable cardiac monitors, providing physicians with actionable data and new patient insights," said Professor Paolo Della Bella, M.D., head of the arrhythmia department at IRCCS San Raffaele Scientific Institute in Italy. "The real-time data, advanced algorithms and diagnostic accuracy empower physicians to deliver more personalized and effective care. For those with abnormal heart rhythms, Assert-IQ ICM provides peace of mind and the freedom to live their lives with confidence."

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.