SynCardia Systems has obtained approval from the US Food and Drug Administration (FDA) to carry out a clinical trial, which will assess the effectiveness of the SynCardia temporary Total Artificial Heart for permanent use.
According to the company, FDA has approved the SynCardia Investigational Device Exemption (IDE) application to conduct destination therapy study in 19 patients, who do not qualify for a donor heart transplant.
SynCardia Systems president and CEO Michael Garippa said: "The SynCardia Total Artificial Heart is already FDA-approved as a bridge to a donor heart transplant.
"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 FDA-approved Freedom portable driver will be received by the clinically stable patients implanted with the SynCardia Total Artificial Heart. Freedom portable driver powers the SynCardia Heart and allows patients increased mobility.
This artificial heart is said to be 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.
The SynCardia Total Artificial Heart replaces the native heart’s two failed ventricles and four valves, similar to a donor heart transplant.
The 70cc SynCardia 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.