SynCardia Systems, a manufacturer of a temporary total artificial heart, has revealed a prototype of its new four-pound Companion II Driver, the next generation in its Companion Driver System series, at the 28th annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) held in Boston last week.
“Weighing only four pounds, the Companion II is intended to be the smallest pneumatic driver for the artificial heart in the world,” said Rodger Ford, SynCardia’s president and CEO.
The Companion Drive System is designed to be docked into the Companion Hospital Cart for use in the operating room and intensive care unit, the Tucson, Ariz.-based Syncardia said. Once the CardioWest artificial heart patient is stable, the Drive Unit is designed to be re-docked into the Companion Discharge Caddy for mobility around the hospital and recovery at home.
SynCardia said it will submit an application to the FDA this year to conduct an IDE clinical study of the Companion Drive System at 22 U.S. hospitals. SynCardia also said it has been working with the FDA and CMS for more than a year to bring the new technology to its patients.