The device, which was designated a breakthrough by the FDA, is intended for use in patients with heart failure who are not candidates for other heart disease treatments, including cardiac resynchronization therapy.
“Patients with advanced heart failure have limitations of physical activity, experiencing fatigue, palpitation or shortness of breath with activity and may not benefit from standard treatments, including currently marketed drugs and devices. This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure,” said Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health.
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