SynCardia Systems, Inc.

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

Published in Blood Weekly, November 19th, 2009

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,"...

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Source: Blood Weekly (2009-11-19)

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