FDA Approves the SynCardia Total Artificial Heart for Destination Therapy Study
19 patients who are not eligible for a donor heart transplant will participate in the pivotal clinical study to evaluate the SynCardia Total Artificial Heart for permanent use.
TUCSON, Ariz. – Jan 6, 2015 – SynCardia Systems, Inc. has received FDA approval to conduct a clinical study of the effectiveness of the SynCardia temporary Total Artificial Heart for permanent use, also called destination therapy.
On December 18, 2014, the United States Food and Drug Administration (FDA) approved the SynCardia Investigational Device Exemption (IDE) application to conduct the study in 19 patients who do not qualify for a donor heart transplant.
“The SynCardia Total Artificial Heart is already FDA-approved as a bridge to a donor heart transplant.” says Michael P. Garippa, President and CEO of SynCardia Systems, Inc. “This is an important step for SynCardia to advance the use of the Total Artificial Heart to a new group of patients who are not currently eligible for a donor heart.”
“The study will generate data on the effective use of the SynCardia Heart in these patients as a way for them to recover from heart failure and continue with a near-normal lifestyle,” Garippa added.
Clinically stable patients implanted with the SynCardia Total Artificial Heart will receive the FDA-approved Freedom® portable driver, which powers the SynCardia Heart and allows patients increased mobility. The high volume of blood flow provided by the SynCardia Heart, combined with the mobility provided by the Freedom portable driver, is designed to allow patients who were once near death to enjoy a full life at home and in their communities.
The SynCardia Total Artificial Heart is implanted in patients who are dying of end-stage biventricular heart failure in which the two ventricles of the native heart cannot pump enough blood for the patient to survive.
Similar to a donor heart transplant, the SynCardia Total Artificial Heart replaces the native heart’s two failed ventricles and four valves. It is the only approved device that eliminates the source of end-stage biventricular heart failure.
Because of the growing demand for donor hearts, and the flat supply, many patients live for months or years supported by the SynCardia Total Artificial Heart. The longest a person has lived with the SynCardia Heart was 1,374 days—nearly four years—before his donor heart was successfully transplanted.
The 70cc SynCardia Total Artificial Heart is FDA approved for use as a bridge to transplant.
Caution: The 70cc SynCardia Total Artificial Heart, when used for destination therapy, is an investigational device, limited by United States law to investigational use.
SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and 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 1,350 implants of the SynCardia Total Artificial Heart account for over 400 patient years of life on the device. Since January 2010 more than 550 SynCardia Hearts have been implanted.
The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 76 years old. The longest a patient has lived with a SynCardia Heart was nearly four years (1,374 days) before receiving a successful donor heart transplant Sept. 11, 2011.
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged the hospital to live at home and in their communities. The wearable Freedom driver has been used by more than 200 patients, accounting for over 120 years of support