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.
TUCSON, Ariz., Aug. 18, 2015 /PRNewswire/ -- 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.)
The SynCardia Heart is already FDA-approved as a bridge to a donor heart transplant and has been implanted more than 1,475 times.
The SynCardia Heart is the only commercially available Total Artificial Heart in the United States, European Union and Canada. Similar to a heart transplant, the SynCardia Heart eliminates the source of end-stage heart failure by replacing the heart's two dying ventricles and four heart valves.
The 13.5-pound Freedom® portable driver allows clinically stable patients to be discharged from the hospital to resume their lives at home and in their communities. Patients can recover and gain strength as they wait for their matching donor hearts.
Discharge helps Freedom® portable driver patients to get in better shape for their heart transplants while getting back to their daily lives.
In Europe, the SynCardia Total Artificial Heart powered by the Freedom® portable driver is used as a bridge to donor heart transplant for the 70cc and the new 50cc SynCardia Total Artificial Heart.
The Freedom® portable driver also won 2013 and 2014 Edison Awards. Nominees are judged by a panel of more than 3,000 leading business executives, academicians and leaders in product development, design, engineering, science and medicine.
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About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. in Tucson, Arizona is the manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart for use as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,475 implants of the SynCardia Total Artificial Heart account for over 480 patient years of life on the device. Since 2012 more than 500 SynCardia Hearts have been implanted.
The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 80 years old. The longest a patient has lived with a SynCardia Heart before receiving a donor heart transplant was nearly four years (1,374 days).
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged from the hospital and live at home and in their communities. The Freedom® portable driver has been used by more than 235 patients, accounting for over 160 patient years of support.
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SOURCE SynCardia Systems, Inc.