Press Release:
Investigational Device Exemption Application Submitted to FDA
for Freedom™ Discharge Driver to Power SynCardia Total Artificial Heart
1st U.S. Discharge Driver Designed to Free Stable Total Artificial Heart Patients from the Hospital
Currently, the only FDA-approved driver for powering the Total Artificial Heart is “Big Blue” (right), which confines stable Total Artificial Heart patients to the hospital while they wait for a donor heart transplant.
TUCSON, Ariz. – Nov. 5, 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,” 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.
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About SynCardia Systems, Inc.
SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary Total Artificial Heart. There have been more than 850 implants of the Total Artificial Heart, accounting for more than 190 patient years of life on the device.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people 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.
For additional information, please visit: http://www.syncardia.com
or follow SynCardia on Twitter – @SynCardia_News
Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660
SynCardia temporary CardioWest™ Total Artificial Heart.
