Recent developments surrounding the SynCardia temporary Total Artificial Heart will make the device available to three times the number of people suffering from end-stage biventricular heart failure. Over 300 SynCardia Hearts have been implanted worldwide since 2012.
Clinical trials awaiting US Food and Drug Administration (FDA) approval will document the use of a new smaller 50cc version of the SynCardia Total Artificial Heart, making it available to people of smaller size, including most women, men and many adolescents.
The current 70cc SynCardia Total Artificial Heart, the world’s first and only FDA, Health Canada and CE approved total artificial heart, is approved as a bridge to transplant. It has been implanted in nearly 1,300 people worldwide.
Once approved by the FDA, the studies are expected to launch later this year. They will also investigate using the SynCardia Heart for permanent use (or as destination therapy). This allows patients who do not qualify for a donor heart transplant — because of other health conditions or age — to receive a SynCardia heart.
Once the clinical trials are underway, both the 50cc and 70cc SynCardia Total Artificial Heart will be available as both destination therapy and bridge to transplant at study sites. The 70cc SynCardia Heart as a bridge to transplant is available at all SynCardia Certified Centres. Like a human heart transplant, the SynCardia Heart eliminates the symptoms and source of end-stage biventricular heart failure, when the left and right ventricles can no longer pump enough blood for the patient to survive.
