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SynCardia Systems, Inc.

Press Release:

SynCardia Total Artificial Heart Replaces
Left Ventricular Assist Devices in 7 Patients

With Total Artificial Heart, Two Patients Bridged to Transplant,
Five Currently Waiting for a Matching Donor Heart

 

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TUCSON, Ariz. – May 24, 2012 – SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that the SynCardia temporary Total Artificial Heart has recently replaced left ventricular assist devices (LVADs) in seven patients suffering from end-stage heart failure.

An LVAD is a continuous-flow, mechanical pump that is implanted adjacent to the heart to assist or take over the pumping function of the left heart ventricle. However, professional papers have documented that right ventricular dysfunction/failure is revealed or develops in 10-30% of patients who receive an LVAD.

"Heart failure is a chronic and progressive disease that usually affects the left ventricle first," said Michael Garippa, SynCardia Chairman/CEO/President. "At the time these patients received an LVAD, it was an effective treatment option. However, their heart failure progressed to where left-side support was no longer enough. The Total Artificial Heart was implanted as the optimal therapy to provide the biventricular support these patients needed to survive. This is a testament to the Total Artificial Heart becoming the new standard of care for end-stage biventricular failure." 

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In February 2012, a 26-year-old German man who had previously been supported with an LVAD received his matching donor heart after 646 days (1 year, 9 months) of life with the Total Artificial Heart. The same month, a 57-year-old woman in Virginia received her heart transplant after 103 days of support. The other five LVAD patients received the Total Artificial Heart between March and May 2012 and are currently waiting for a matching donor heart.

"For patients with left ventricular failure, LVADs help improve quality of life," said Garippa. "However, while LVADs may slow the progression of heart failure, they do not stop it. SynCardia's Total Artificial Heart is the only device that eliminates the symptoms and source of end-stage biventricular heart failure."

Five of the former LVAD patients received the Total Artificial Heart in the United States, and the other two in Germany and Greece. Currently, there are more than 50 Total Artificial Heart patients awaiting transplant at 29 SynCardia Certified Centers worldwide.

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About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the SynCardia Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

 

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