The current 70cc Total Artificial Heart fits a majority of men and some women. It is designed for use in patients with a Body Surface Area (BSA) of 1.7m² or greater. SynCardia is currently developing a smaller 50cc Total Artificial Heart designed for patients with a BSA of 1.2-1.7m².
There are currently 74 SynCardia Certified Centers worldwide, including 39 in the U.S. There are an additional 30 hospitals currently undergoing SynCardia's four-phase certification process.
The Freedom portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.
CAUTION – The Freedom portable driver is an investigational device, limited by United States law to investigational use.The 50cc Total Artificial Heart is not for Human Use. This product is in the research and development phase and will not be available for sale in the United States or Europe until all regulatory requirements have been met. Like SynCardia on http://www.facebook.com/pages/SynCardia-Systems-Inc/191245900926019Follow SynCardia on Twitter – http://twitter.com/SynCardia About the SynCardia temporary Total Artificial HeartSynCardia Systems, Inc. ( Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart… read more SOURCE SynCardia Systems, Inc.