SynCardia’s Total Artificial Heart Receives HUD Designation for Destination Therapy from FDA

Approval of HDE Will Allow Up to 4,000 U.S. Patients Not Eligible for Transplant to Receive the Total Artificial Heart on a Permanent Basis

Pietro Zorzetto is the longest supported SynCardia Total Artificial Heart patient in the world. He received his heart transplant on Sept. 9, 2011, after 1,374 days (nearly 4 years) of life with the Total Artificial Heart (Source: SynCardia Systems, Inc.) .

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 U.S. Food and Drug Administration (FDA) has approved a Humanitarian Use Device (HUD) designation   for the SynCardia temporary Total Artificial Heart to be used for destination   therapy in addition to its current PMA approval as a bridge to transplant.

“This is a huge milestone that   with approval of our HDE, will allow the Total Artificial Heart to save the   lives of up to 4,000 U.S. patients each year who are not eligible for   transplant,” said Michael Garippa, SynCardia Chairman/CEO/President.

The FDA approval letter of the   HUD request designates the Total Artificial Heart for use in U.S. patients   “at risk of imminent death from non-reversible biventricular heart failure   who are not eligible for cardiac transplant and have a body surface area   (BSA) of ≥ 1.7m2.” SynCardia is preparing a Humanitarian Device Exemption   (HDE) to submit to the FDA.

“Historically, the Total Artificial Heart had been limited   to temporary use because U.S. patients couldn’t leave the hospital with the   400-pound driver,” said Garippa. “However, the new 13.5-pound Freedom®   portable driver* has leveled the playing field in mechanical circulatory   support. By making patient discharge possible, the Freedom driver has made   the Total Artificial Heart a viable option to support patients for the rest   of their lives while allowing hospitals to make the best choice for each   individual patient based on their medical needs”… read more

The SynCardia temporary Total Artificial   Heart is approved as a
bridge-to-transplant for people dying from irreversible, end-stage   biventricular failure.

For more information contact:

Don Isaacs • 520-955-0660 •

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