FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Medtronic’s Reveal XT Cardiac Monitor Meets Primary Endpoint in Pivotal Trial

Feb. 18, 2014

Medtronic’s Reveal XT insertable cardiac rhythm monitor met its primary endpoint in the global prospective Crystal AF study, detecting atrial fibrillation at six months in 6.4 times more patients than standard care methods such as electrocardiograms, Holter monitors and short-term diagnostics, the company said Friday.

The positive impact was even greater at one year and 36 months, with Reveal XT detecting AF in 7.3 and 8.8 times as many patients, respectively, as standard care, the Minneapolis, Minn., devicemaker said. AF increases a patient’s risk of stroke by a factor of five and is difficult to detect because patients often have no obvious symptoms, according to Medtronic.

The Crystal AF trial enrolled 441 patients at 55 centers in Canada, Europe and the U.S. between June 2009 and April 2012. All of the subjects were 40 years of age or older and had suffered a recent cryptogenic symptomatic transient ischemic attack or cryptogenic ischemic stroke.

The trial results show that AF occurs in cryptogenic stroke patients much more often than previously believed, Medtronic spokesman Joey Lomicky told Device Daily Bulletin. Identification of AF by long-term, continuous cardiac monitoring allows doctors to switch at-risk patients from antiplatelet to oral anticoagulation therapy, thereby reducing the risk of a subsequent stroke by 65 percent, he said.

Reveal XT is implanted under the skin of the chest and is capable of monitoring the heart’s electrical activity for up to three years, storing ECG data every time it detects abnormal cardiac rhythms. — Lena Freund

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