Picard Medical, parent company of SynCardia System, maker of the world’s first total artificial heart (TAH) approved by both the U.S. Food and Drug Administration (FDA) and Health Canada, has completed the first in vivo implantations of the Emperor TAH.

The Emperor TAH was successfully implanted in three preclinical models, with each model taken off bypass without issues. The company said through the observation periods, the device provided full and stable blood circulation, used energy efficiently, and operated without technical problems.

The TAH operated in a way that closely mirrors how a human heart works. It produced stable hemodynamics, showed physiologic preload sensitivity, and maintained afterload independence. These behaviors reflect the Frank Standing response, the natural mechanism by which the heart adjusts pumping strength based on how much blood fills it.

All results, Picard Medical said, were consistent with its lab performance goals for Emperor. The positive outcomes seen after the implantations mark a milestone in developing Emperor as the next-gen successor to the FDA-approved SynCardia total artificial heart.

“We are excited by these initial data,” said Picard Medical CEO Patrick NJ Schnegelsberg. “The successful completion of these first implantations brings SynCardia back to the forefront of innovation in total artificial heart technology. This milestone strengthens our position as the global leader in total artificial hearts and is yet another step that validates the potential of the Emperor platform.”

SynCardia will continue with further preclinical studies to refine final system parameters.

“Our very positive experience with implanting the next-generation TAH in three separate in vivo models confirms that the Emperor platform is progressing as designed and confirms its potential to become a fully implantable alternative to heart transplantation,” added Andre R. Simon, MD, P.h.D, FRCS, Picard Medical’s VP of medical affairs. “The performance characteristics observed in each of these acute experiments validate key engineering choices and support continued program acceleration for this novel device which could be an even further improvement to a patient’s quality of life.”