SynCardia Systems, Inc. (SynCardia), manufacturer of the SynCardia temporary CardioWest Total Artificial Heart, has submitted an application to the US Food and Drug Administration (FDA) to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom discharge driver, designed to power the Total Artificial Heart outside the hospital.
“Stable Total Artificial Heart patients in the U.S. are currently confined to the hospital by the large “Big Blue” hospital driver that powers the heart,” said Rodger Ford, SynCardia president and CEO.
“The IDE submission includes a request to conduct the clinical study at 30 U.S. centers,” said Mary Pat Sloan, VP of Global Training and Customer Support. “While many of our trial sites have been identified, we will be following up with additional transplant centers that have expressed interest in participating in the Freedom driver study.”
Later this month, SynCardia will submit the Freedom driver design dossier to the Notified Body for examination for the CE Mark in Europe.