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Article: Investigational Device Exemption Application Submitted to FDA for Freedom™ Discharge Driver to Power SynCardia Total Artificial Heart.(Clinical report)
- Article from:
- Blood Weekly
- Article date:
- November 19, 2009
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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 (see also SynCardia Systems, Inc.).
"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 ...