FDAnews Device Daily Bulletin

Medtronic Releases One-Year Atrial Fibrillation Study Results

April 25, 2016

Medtronic has released positive results from a one-year study evaluating its Reveal insertable cardiac monitor for patients suffering from cryptogenic stroke.

Results show the monitor yielded an atrial fibrillation rate of 16.3 percent, a 32 percent increase from the company’s previous rate from its CRYSTAL AF Study that was published in the New England Journal of Medicine in 2014.

The device transfers data to a wireless bedside monitor and can detect and record abnormal heart rhythms for up to three years. — Anisa Jibrell


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