The Start of SynCardia Total Artificial Heart Destination Clinical Study Wins Edison Awards’ Top Honor
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.
August 18, 2015 /3BL Media/ - 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.
“This will provide study patients with a second chance at life,” Garippa adds. “It is an important step to making SynCardia’s Total Artificial Heart technology available to patients who need it.”
The clinical study is expected to enroll its first destination therapy patients in the coming months. (Caution - The 70cc SynCardia Total Artificial Heart, when used for destination therapy, is an investigational device, limited by United States law to investigational use.)
