Gold Award recognizes the FDA approval of a study into the effectiveness of the SynCardia Total Artificial Heart powered by the Freedom® portable driver for end-stage biventricular heart failure patients who don’t qualify for donor heart transplants.
An FDA-approved clinical study for destination therapy with the SynCardia Total Artificial Heart powered by the Freedom® portable driver won a Gold Edison Award
SynCardia Systems, Inc. earned a 2015 Gold Edison Award for the clinical study into the effectiveness of the SynCardia temporary Total Artificial Heart powered by the Freedom® portable driver for destination therapy, also known as permanent use.
The awards that recognize the best in innovative product and service development were presented at a ceremony in New York City. SynCardia was among four finalists in its section, surgical tools.
“The FDA-approved Investigational Device Exemption (IDE) study will allow 19 patients in the primary arm of the study and up to 19 patients in the secondary arm, those who do not meet study criteria under the current approved protocol. Patients in the study do not qualify for a donor heart transplant,” says Michael P. Garippa, CEO and President of SynCardia…
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- Medical Professionals Videos
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- Freedom® Portable Driver
- Companion 2 Hospital Driver
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World’s first and only approved Total Artificial Heart
1,475+ implants account for over 480 patient years of support
The SynCardia temporary Total Artificial Heart is approved for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
Don Isaacs • 520-955-0660 • disaacs@syncardia.com