The company's Optimizer technology is implanted in a patient and delivers CCM therapy, which optimizes heart contraction by allowing more oxygen-rich blood to reach the body. This system aims to improve outcomes for patients who receive treatment for moderate to severe heart failure.
The FDA's action will enable MRI scans to be performed on patients who have been implanted with Optimizer, a device about the size of a pacemaker. The device delivers timed electrical pulses to the heart during the absolute refractory period of the beating cardiac cycle, just after the heart contracts.
Optimizer has been cleared for use in the U.S. and some 40 other countries. About 5,000 have been treated with the device.
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