SynCardia CE marks artificial heart power system
This article was originally published in Clinica
SynCardia Systems has CE marked the Freedom driver system, which powers its CardioWest Total Artificial Heart, for sale in Europe. The Tucson, Arizona firm claims the device "will allow stable European Total Artificial Heart patients to enjoy a quality lifestyle…while they wait for a matching donor heart." Immediately after a patient receives a Total Artificial Heart, hospital drivers are used to power the implant until their condition stabilises. Once stable, patients can be switched to the Freedom driver and discharged from the hospital. The driver weighs 13.5lbs (6.1kg), and includes two lithium ion batteries and a power adaptor. It can be carried by the patient in a specially designed backpack or shoulder bag. It is 60% lighter than SynCardia's older CE-marked "proof of concept" portable driver, which weighs approximately 35 lbs and is transported in a wheeled caddy. SynCardia has submitted an application to the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom driver in the US.