The first three recipients of SynCardia Systems’ temporary Total Artificial Heart have been discharged from hospital, after being given the company’s Freedom portable driver.
The driver weighs in at 13.5lbs and is the first wearable device that can power the Total Artificial Heart outside of a hospital.
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SynCardia’s Total Artificial Heart is designed as a temporary bridge for patients with biventricular failure who are waiting for a donor heart as a permanent replacement.
The device has received CE Mark approval for use in Europe, and conditional approval from the US Food and Drug Administration to undergo an IDE (investigational device exemption) clinical study.
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