SynCardia has won FDA approval to pursue a clinical study of its 50cc temporary total artificial heart. Clinical data from the first six months of the study will be used to support premarket approval of the device, the Tucson, Ariz., devicemaker said Monday.
The 50cc version is meant for most women, smaller men and many adolescents —patients whose bodies can’t take the larger 70cc total artificial heart, said CEO and President Michael P. Garippa.
Based on the FDA approval, SynCardia could include as many as 30 heart failure patients in the study, with each patient receiving the artificial heart as a bridge to heart-donor transplant. All patient chest cavities will be 3D modeled to better understand who can benefit from the device, the company said.
SynCardia will follow patients for as long as two years to gather data on their experiences.
The SynCardia total artificial heart is the only CE-marked, Health Canada- and FDA-approved device capable of temporarily halting end-stage biventricular heart failure, which occurs when the heart’s two ventricles stop pumping enough blood for the patient to live, the devicemaker claims.
The device is CE-marked in both the 50cc and 70cc sizes.
More than 550 total artificial hearts have been implanted since January 2010, SynCardia said. — Jason Scott