USA – Abbott has received FDA approval for its latest 3D cardiac mapping platform, which is intended to help physicians target abnormal heart rhythms.

The EnSite X EP system inserts a catheter into the heart to map out the regions of the cardiac muscle where unsteady electric pulses can cause irregular heartbeats, and then guides surgeons through ablation procedures to treat those areas.

The probe uses Abbott’s omnipolar technology, which allows it to accurately record 360 degrees of electrical activity in real time regardless of how the catheter is oriented within the heart’s chambers.

The system, according to the company, can map 1 million points in the heart while allowing the user to use both unipolar and bipolar measurement principles, allowing for both a broader view of the heart and pinpoint measuring for specific areas of concern.

Millions of Americans are affected by abnormal heart rhythms caused by malfunctions in the heart’s electrical pathways.

If left untreated, these breakdowns can cause erratic heartbeats or cause the heart to beat too fast or too slow, which can have serious consequences for a patient’s health.

Atrial fibrillation (AFib), the most common arrhythmia, is a condition in which the heart’s chambers are out of sync, causing them to beat rapidly and chaotically. In some cases, untreated arrhythmias such as AFib can lead to heart failure or stroke.

Cardiovascular ablation is increasingly being used to treat cardiac arrhythmias because, unlike medication, it treats the condition at its source by disrupting the area of the heart that generates abnormal heart beats.

Cardiac mapping is essential for successful ablation therapy because it provides physicians with highly precise, accurate, and detailed images of the heart, allowing them to determine the best location to deploy therapy safely and effectively.

Abbott’s new approval comes just days after Medtronic announced a US$925 million tuck-in deal to acquire Affera and its catalog of heart-mapping catheters at the annual J.P. Morgan Healthcare Conference.

This acquisition, which is expected to close by November, will include Affera’s current development products, such as the Prism-1 cardiac mapping and navigation platform, the Arc-10 Linear coronary sinus catheter, and the Sphere-9 catheter, which offers both focal ablation therapy and high-definition mapping capabilities.


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