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Medical Devices / Submissions and Approvals

Miracor Earns Breakthrough Designation for STEMI Heart Attack Treatment

Aug. 23, 2019

The FDA granted Miracor breakthrough designation for its PiCSO (pressure-controlled intermittent coronary sinus occlusion) device for treating heart attacks in which a coronary artery is completely blocked.

The device is designed to clear coronary microcirculation by stopping blood delivery into the right atrium through the coronary sinus, to improve blood flow to the area of obstruction after a ST-elevation myocardial infarction (STEMI) heart attack.

ST elevation refers to a reading on an electrocardiogram where the trace is abnormally high. STEMI heart attacks are considered the “classic” heart attacks and occur when a coronary artery has become totally blocked, causing a large portion of the heart to stop receiving blood.

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