SynCardia launches driver technology to power artificial hearts
SynCardia Systems, manufacturer of the SynCardia temporary CardioWest Total Artificial Heart, introduced its 12-lb Freedom discharge driver at the International Society for Heart and Lung Transplantation (ISHLT) meeting in Paris this week.
The light and wearable Freedom driver is designed to provide patients with stable SynCardia Total Artificial Heart patients with a quality "lifestyle" outside the hospital while they wait for a matching donor heart, according to the Tucson, Ariz.-based company.
Currently in the U.S., stable Total Artificial Heart patients cannot be discharged. SynCardia said it plans to submit applications for CE approval of the Freedom driver in Europe and to the FDA to conduct an investigational device exemption (IDE) clinical study of the Freedom driver in the U.S. in the second quarter.
The light and wearable Freedom driver is designed to provide patients with stable SynCardia Total Artificial Heart patients with a quality "lifestyle" outside the hospital while they wait for a matching donor heart, according to the Tucson, Ariz.-based company.
Currently in the U.S., stable Total Artificial Heart patients cannot be discharged. SynCardia said it plans to submit applications for CE approval of the Freedom driver in Europe and to the FDA to conduct an investigational device exemption (IDE) clinical study of the Freedom driver in the U.S. in the second quarter.