A multi-disciplinary team from Cedars-Sinai Heart Institute will become the first in Los Angeles to complete certification to implant the SynCardia Systems’ temporary Total Artificial Heart.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure.
Tucson-based SynCardia Systems said the Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.
SynCardia is currently conducting an FDA-approved investigational device exemption (IDE) clinical study of the Freedom driver, the first US portable driver designed to power SynCardia’s Total Artificial Heart both inside and outside the hospital.
Weighing 13.5 lbs, the wearable Freedom driver is designed to allow stable Total Artificial Heart patients who meet study criteria to live at home and in their community while they wait for a matching donor heart.
Mechanical Circulatory Support Program medical director Jaime Moriguchi said they are excited to offer the Total Artificial Heart as a bridge to transplant for patients suffering from end-stage, biventricular heart failure who have exhausted all other treatment options.
"Similar to a heart transplant, the Total Artificial Heart is the only device that eliminates the symptoms and source of biventricular failure by replacing both ventricles and the four valves," Moriguchi said.