Findings Reinforce Patient Benefit of Reveal LINQ in Real-World Setting

New Data Demonstrate Cost-Effectiveness of Long-Term, Continuous Cardiac Monitoring with Potential to Prevent Recurrent Strokes

DUBLIN and NASHVILLE - Medtronic plc (NYSE: MDT), today announced the results of a new "real-world" study of patients who have had a cryptogenic stroke (stroke of unknown cause), in which the Reveal LINQ(TM) Insertable Cardiac Monitor (ICM) detected atrial fibrillation in everyday practice at an even greater rate than that found in a recent, rigorously-conducted clinical trial (the CRYSTAL AF Study, which was published in The New England Journal of Medicine).


The observational real-world study, which is being presented at theAmerican Stroke Association's International Stroke Conference 2015 in Nashville, Tennessee, this week, evaluated 1,247 cryptogenic stroke patients across the U.S. to determine whether atrial fibrillation (AF) could be detected using long-term, continuous cardiac monitoring (Reveal LINQ ICM). At 182 days of monitoring (median), AF was detected in 147 patients, resulting in an AF detection rate of 12.2 percent, which was nominally 37 percent higher than the rate observed in CRYSTAL AF at the same time point.

"Unlike a randomized study, an observational study provides a practical way to study real-world clinical practice. What's most exciting is that the detection of AF in real clinical practice exceeded that observed in the rigorously-controlled CRYSTAL AF study, allowing physicians to intervene even more with stroke preventive therapies," said study co-author Mark Richards, Ph.D., M.D., director of Arrhythmia Services at ProMedica Physicians Cardiology in Toledo, Ohio. "This suggests that AF may go undetected at an even greater rate and reinforces the benefits of long-term rhythm monitoring in cryptogenic stroke patients."

Atrial fibrillation is a common cardiac condition when the heart beats irregularly or rapidly; patients with AF are five times more likely to have a stroke1 due to small blood clots that may form in the heart and subsequently travel to the brain, obstructing a major blood vessel leading to an ischemic stroke.

Each year, approximately 692,000 Americans experience ischemic strokes (the most common type of stroke); cryptogenic strokes account for approximately 20 - 40 percent of ischemic strokes in the majority of modern stroke registries and databases.2-8

Undiagnosed AF is believed to be responsible for a significant portion of cryptogenic strokes; however, because AF often has no symptoms, it may not be detected by conventional monitoring techniques such as in-hospital monitoring, electrocardiography or traditional ambulatory cardiac monitors such as a Holter. Unlike conventional monitoring methods, the Reveal LINQ ICM automatically and continuously detects and records abnormal heart rhythms for up to three years.

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