SynCardia wins FDA trial OK

March 30, 2010

By hammersmith

[Source: Arizona Daily Star] – The U.S. Food and Drug Administration approved a clinical trial called an Investigational Device Exemption study for a Tucson company’s portable power source for artificial hearts.

The FDA uses IDE studies to collect safety data in order to approve devices for the market.

The Tucson-based SynCardia Systems, Inc.-manufactured Freedom driver system will allow heart patients to leave the hospital as they await their transplants rather than be stuck in hospital rooms to giant, immobile drivers.

For more information: SynCardia wins FDA trial OK