Abbott receives CE mark for 6-year insertable cardiac monitor

Dive Brief:

• Abbott has received a CE mark for an insertable cardiac monitor (ICM) with a six-year battery life, the company said Monday.

• The Assert-IQ ICM monitors a patient’s heart continuously to detect arrhythmias for either three or six years. Abbott sees the six-year option as suitable for longer-term monitoring of people at risk of developing arrhythmias.

• Assert-IQ’s six-year battery life exceeds the 4.5-year lifespan of Medtronic’s Linq II device. The batteries in Biotronik’s Biomonitor III and Boston Scientific’s Lux-Dx II last for four years and three years, respectively.

Dive Insight:

ICM competition has intensified in recent years. Boston Scientific began selling the first version of its Lux-Dx ICM in Europe in 2022 and received U.S. clearance for its next-generation device in 2023. 

Abbott has responded with Assert-IQ, positioning battery life as the differentiator. Abbott is selling a three-year version of the ICM for traditional monitoring applications such as diagnosing fainting or heart palpitations, or detection of abnormal heart rhythms. The company has designed the six-year version for monitoring patients who are undergoing therapy and are at risk of developing arrhythmias, or irregular heartbeat.

The device is inserted under the skin of a patient’s chest during a minimally invasive procedure, with the ability to continuously monitor for irregular heartbeats. The monitor is designed to connect with a transmitter, typically a patient's smartphone, through Bluetooth technology, where it checks rhythms every 20 seconds and transmits to a clinic’s portal.

As well as offering a longer battery life, Abbott contends that it has achieved the extra longevity without compromises made by its rivals. The 4.5-year lifespan of Linq II is achieved by limiting the app, Abbott said, and the first version of Lux-Dx has a two-year duration under some settings.

Leonard Ganz, chief medical officer of Abbott's cardiac rhythm management business, said in a statement that Assert-IQ will expand access to “long-term monitoring and more clinically relevant information, and allow care providers to make clinical decisions faster and with more precision.” Ganz added that physicians are increasingly relying on ICM to diagnose “various heart conditions.”

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