SynCardia Systems, Inc announced that it will be completing the study of 12-lb Freedom discharge driver by August 2010.
12-lb Freedom discharge driver is a small, light and wearable next generation pneumatic driver. It is designed to stabilize SynCardia Total Artificial Heart in patients till they receive a matching donor heart. The Freedom driver uses smart batteries designed to provide hours of freedom between charges. It also features optional Freedom Power Pack that is designed to provide additional hours of freedom so patients can enjoy a full day of activity.
The purposes of this study are to confirm that the Freedom Driver System is a suitable pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers can be trained to manage the Freedom Driver System safely outside the hospital.
The 60 patient study is not yet open for participant recruitment. The official title of the study is “The SynCardia Freedom Driver System IDE Study”.