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Article: Investigational Device Exemption Application Submitted to FDA for Freedom[TM] Discharge Driver to Power SynCardia Total Artificial Heart.(Clinical report)
- Article from:
- Business Wire
- Article date:
- November 5, 2009
CopyrightCOPYRIGHT 2009 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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1(st) U.S. Discharge Driver Designed to Free Stable Total Artificial Heart Patients from the Hospital
TUCSON, Ariz. -- On Nov. 5, SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the SynCardia temporary CardioWest[TM] Total Artificial Heart, announced it has submitted an application to the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom[TM] 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 ...