The US Food and Drug Administration (FDA) has granted approval for Syncardia Systems to conduct a clinical trial, which is designed to evaluate the effectiveness of the SynCardia temporary Total Artificial Heart for permanent use.
In December 2014, the FDA approved the SynCardia investigational device exemption (IDE) application to carry out the destination therapy trial in 19 patients, who do not qualify for a donor heart transplant.
The FDA-approved Freedom portable driver that powers the artificial heart and allows patients increased mobility will be given to clinically stable patients implanted with the SynCardia Total Artificial Heart.
The artificial heart will be implanted in patients who are dying of end-stage biventricular heart failure, which is when the two ventricles of the native heart cannot pump enough blood for the patient to survive.
SynCardia Systems president Michael Garippa said: "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."
The company said the SynCardia Total Artificial Heart replaces the native heart’s two failed ventricles and four valves, similar to a donor heart transplant. The 70cc Total Artificial Heart received FDA approval for use as a bridge to transplant.
Image: French resident Frédéric Thiollet has been supported by the SynCardia Total Artificial Heart for 1,250 days, nearly three and half years. Photo: courtesy of SynCardia Systems, Inc.