EU gives nod to SynCardias portable driver for artificial heart

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SynCardia’s wearable Freedom driver system that allows patients implanted with its CardioWest Total Artificial Heart to be home while awaiting a matching donor heart has received the CE mark of approval for distribution across Europe.

According to the Tucson, Ariz.-based company, the Freedom driver is 13.5 pounds, 60 percent lighter than the previous portable device, and can fit into a backpack or shoulder bag.

The company has submitted an Investigational Device Exemption to the FDA for its approval to conduct a clinical trial of the Freedom driver in the U.S.
Currently, over 800 patients with biventricular failure have been implanted with the CardioWest artificial heart.