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100th SynCardia Total Artificial Heart Implanted in 2013
Date:7/25/2013

tified Center in 2006.

"From January 2012 through the first seven months of 2013, there have been 230 implants of the Total Artificial Heart," said Garippa. "This is nearly double the number of implants performed during the same 19-month period from 2010 to 2011, in which 120 implants were performed."

SynCardia is currently awaiting a response from the FDA regarding its premarket approval supplement for the Freedom® portable driver, the world's first wearable power supply for the Total Artificial Heart. To date, 140 patients have been supported by the Freedom portable driver worldwide, accounting for more than 68 patient years of support. Of these patients, 89 were discharged from the hospital to wait for a matching donor heart at home and in their communities.

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.

About the SynCardia temporary Total Artificial Heart

SynCardia 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, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure). There have been more than 1,200 implants of the Total Artificial Heart, accounting for more than 315 patient years of life on the device.

Similar to a heart transplant, the
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SOURCE SynCardia Systems, Inc.
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