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The UK National Institute for Health and Care Excellence on Tuesday issued draft guidance recommending the use of Medtronic's Reveal LINQ monitor to detect atrial fibrillation after stroke of unknown cause. The device is the first implantable cardiac monitor (ICM) to be recommended for NHS use by NICE.
Meindert Boysen, director of the NICE Centre for Health Technology Evaluation, said "this is an innovative monitor which has the potential to reduce the number of strokes suffered by those with atrial fibrillation." He added that "it may mean fewer hospital visits for those with atrial fibrillation, reduce the need for rehabilitation and mean patients are reassured that atrial fibrillation will be detected in a timely manner so treatment can begin."
The device, which is one-third of the size of an AAA battery, is implanted under the skin in the chest "to track a heart's activity over long periods of time, transmitting data back to the patient's doctor via a mobile phone network," NICE said. The institute added that non-invasive electrocardiogram monitoring should be carried out first before Reveal LINQ, which costs £1800 ($2340), is considered.
Medtronic's ICM system obtained FDA 510(k) clearance and CE-mark approval in 2014 for patients who experience symptoms indicative of cardiac arrhythmia, and for those at increased risk for cardiac arrhythmias.
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