The Reveal is a minimally invasive insertable cardiac monitor (ICM) about one-third of the size of a AAA battery. The device monitors a person’s heartbeat and then sends the data wirelessly to a bedside monitor that communicates with Medtronic’s CareLink network.
Atrial fibrillation occurs when the upper chambers of the heart flutter chaotically instead of beating properly, allowing blood to pool in the heart and potentially form clots. Such clots can travel through the bloodstream and end up in the brain, where they may block blood flow and cause paralysis or death.
About 1 in 6 strokes can be attributed to atrial fibrillation. But as many as 1 in 4 of the estimated 12 million ischemic strokes have no identified cause and are labeled “cryptogenic” strokes, according to an independent study published in the New England Journal of Medicine (NEJM).
Doctors say it’s important to positively diagnose atrial fibrillation because it affects treatment decisions.
People at risk for atrial fibrillation are typically prescribed antiplatelet drugs, which reduce the risk of stroke by 22 percent compared to a placebo. But once fibrillation is identified, doctors will often move patients onto anticoagulation drugs, which reduce the risk of stroke by up to 64 percent compared to antiplatelet drugs, according to the 2014 report in NEJM.
“The prevention of stroke related to atrial fibrillation is a global public health priority,” the NEJM report said. “Strokes due to atrial fibrillation are common and frequently devastating (70 to 80 percent of patients die or become disabled), yet they are largely preventable with anticoagulant therapy.”
The Reveal device generates about $500 million in annual revenue for Medtronic. The company told investors in 2015 that the sales figure could double within five years as the device becomes more widely used in atrial fibrillation and cryptogenic stroke cases.
The Reveal Linq device is FDA-cleared for patients at increased risk for cardiac arrhythmias, and those who have symptoms — such as dizziness, fainting and chest pain — that may suggest a heart problem. The latest iteration of the device is called the Reveal Linq ICM with TruRhythm Detection.