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
TUCSON, Ariz. – April 12, 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 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."
Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart received FDA approval in 2004 as a bridge to transplant for transplant-eligible patients dying from end-stage biventricular heart failure. Currently, the longest a patient has been supported with the Total Artificial Heart is 1,374 days (almost four years) prior to receiving his heart transplant.
During 30 years of use, the valves in the SynCardia Total Artificial Heart have never failed. The diaphragm has a failure rate of less than 1% over more than 1,000 implants (2,000+ diaphragms).
*The Freedom portable driver is the world's first wearable power supply for SynCardia's Total Artificial Heart. It 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.
SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and 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 biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,350 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by 190 patients, accounting for over 110 years of support.