SynCardia’s first-generation TAH became the first system of its kind approved by the FDA and Health Canada. Now, it continues to advance its next-generation system, called “Emperor.”
The company designed the Emperor as a fully implantable, driverless version of the SynCardia TAH. It provides pulsatile flow without requiring a pneumatic driver. Emperor has multiple approved patents backing it, including one garnered as recently as September.
Now, SynCardia reports the first in vivo implantations of the fully implantable Emperor system, using pigs as the pre-clinical animal model. The company says positive outcomes followed the implantations, marking a major milestone for the successor to the original TAH.
More about the initial SynCardia Emperor TAH implants
Investigators successfully implanted Emperor in three pigs, with each taken off bypass without any issues. Observation periods delivered full, stable blood circulation, used energy efficiently and operated without technical problems.
SynCardia said Emperor performed in a way that closely mirrored how the human heart works. All results fell in line with Picard Medical’s laboratory performance goals. The company’s VP of Medical Affairs, Dr. Andre R. Simon, said the device continues to progress toward becoming a fully implantable alternative to heart transplantation.
“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,” said Simon.
SynCardia plans to continue with additional pre-clinical studies to refine the final system parameters.
“We are excited by these initial data,” said Patrick NJ Schnegelsberg, CEO of Picard Medical. “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.”
Schnegelsberg and SynCardia COO Matthew Schuster discussed Emperor early this year during one of our DeviceTalks Weekly podcast episodes:
