Syncardia Systems has received US Food and Drug Administration (FDA) approval to conduct an investigational device exemption (IDE) clinical trial on the effective use of its 50cc temporary Total Artificial Heart in heart failure patients.
Approximately 30 heart failure patients will be enrolled in the trial. Patients will receive the 50cc SynCardia Total Artificial Heart as a bridge to a donor heart transplant.
Under the trial, the 50cc Total Artificial Heart will be implanted in ten pediatric patients between the ages of ten and 18, ten adult patients between the ages of 19 and 75, and ten patients who would not otherwise qualify under the study criteria.
SynCardia Systems president Michael Garippa said: "This study will allow smaller patients who can’t fit the 70cc Total Artificial Heart to benefit from SynCardia’s total artificial heart technology.
"Together, both device sizes are intended to make Total Artificial Hearts available to most women and men, as well as many adolescents."
According to the company, all patients in the trial must be eligible for donor heart transplant and this secondary arm is expected to further characterise the use of the 50cc SynCardia Heart.
In the trial, images of patients’ chest cavities will undergo 3D modelling, in order to better understand the patient populations to benefit from the 50cc Total Artificial Heart.
Data from the trial through the first six months of patient use will be provided to the FDA as part of its review and approval process.
The company said its Total Artificial Heart is the only approved device that reduces the source of end-stage biventricular heart failure in which the native heart’s two ventricles can no longer pump enough blood for the patient to survive.
In Europe, both sizes of the Total Artificial Heart have CE Mark approval for use as a bridge to donor heart transplant or as destination therapy, also known as permanent use.
Image: Pictured left is 70cc and on the right is 50cc SynCardia temporary Total Artificial Hearts. Photo: courtesy of SynCardia Systems, Inc.