SynCardia Sets New Records for Total Artificial Heart Implants, Revenue and Profit in 2012
Company Goals for 2013 Include Introduction of Smaller 50cc Total Artificial Heart
and FDA Approval of the Freedom® Portable Driver and HDE for Destination Therapy
TUCSON, Ariz. – Jan. 17, 2013 – SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today record-setting results for 2012 for implants, revenue and profit.
“2012 was a momentous year for the SynCardia temporary Total Artificial Heart with a record-breaking 125 implants performed at more than 50 Certified Centers worldwide,” said Michael Garippa, SynCardia Chairman/CEO/President. “We expect our growth trajectory to continue in 2013 as we pursue a Humanitarian Device Exemption (HDE) from the FDA for destination therapy and plan to introduce our smaller 50cc Total Artificial Heart designed to fit patients with a body surface area of less than 1.7.”
SynCardia’s accomplishments in 2012 include:
- Completion of required patient enrollment in the FDA clinical study of the Freedom® portable driver, the world’s first wearable power supply for the SynCardia Total Artificial Heart (already approved in Europe)
- Surpassing 100 patients worldwide who have been supported by the Freedom portable driver
- FDA approval of a Humanitarian Use Device (HUD) designation for the Total Artificial Heart to be used for destination therapy
- FDA approval of the Companion 2 Hospital Driver for supporting patients from implant of the Total Artificial Heart until their condition stabilizes
- CE approval in Europe of the Total Artificial Heart with new bileaflet valves
In 2013, SynCardia plans to expand the potential patient population for the Total Artificial Heart through achieving the following milestones:
- FDA approval of its Humanitarian Device Exemption (HDE), the final step required for the Total Artificial Heart to be used for destination therapy in the U.S. in up to 4,000 patients annually who are not eligible for transplant
- CE approval of the 50cc Total Artificial Heart in Europe and FDA approval to conduct an Investigational Device Exemption (IDE) clinical study in the U.S. Once approved, together the 70cc and 50cc Total Artificial Hearts will fit almost all adult men and women, and many adolescents, including patients with congenital conditions.
- FDA approval of the Freedom portable driver for commercial use in the U.S.
There are currently 76 SynCardia Certified Centers worldwide, representing a 280% increase since 2009. There are an additional 32 hospitals currently undergoing SynCardia’s four-phase certification program.
To date, six pediatric hospitals have performed one or more implants of the SynCardia Total Artificial Heart: Texas Children’s Hospital, Children’s Hospital of Philadelphia (CHOP), Phoenix Children’s Hospital, Children’s Hospital of Wisconsin, Cincinnati Children’s Hospital Medical Center and Mattel Children's Hospital UCLA. Two additional children’s hospitals are currently undergoing certification: Lucile Packard Children's Hospital and Arkansas Children's Hospital.
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.
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 over 190 patients, accounting for over 110 years of support.