Pharmacy News Article

6 November 2009 - US-based medical device maker SynCardia Systems Inc said yesterday it has submitted an application to the US Food and Drug Administration (FDA) to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom discharge driver, designed to power the Total Artificial Heart outside the hospital.

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure.

Mary Pat Sloan, VP of Global Training and Customer Support, said that the IDE submission includes a request to conduct the clinical study at 30 US centres, The company said that later this month it will submit the Freedom driver design dossier to the Notified Body for examination for the CE Mark in Europe.

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