Investigational Device Exemption Application Submitted to FDA for Freedom™ Discharge Driver to Power SynCardia Total Artificial Heart

TUCSON, Ariz.--(BUSINESS WIRE)--On Nov. 5, SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, announced it has submitted an application to the 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.

For more information, please visit http://www.syncardia.com.

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.

The SynCardia Total Artificial Heart is the first and only FDA, Health Canada and CE Mark approved Total Artificial Heart in the world. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 170 patient years of life on the device.

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