1,000th Implant of the World's Only
Approved Total Artificial Heart Performed
Total Artificial Heart Available at 56 SynCardia Certified Centers Worldwide
with an Additional 34 Hospitals Currently Undergoing Certification
TUCSON, Ariz. – Feb. 23, 2012 – SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, announced today that the 1,000th implant of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart was performed on Feb. 10 at The University of Arizona Medical Center in Tucson, AZ. Since then, an additional four implants of the Total Artificial Heart have been performed at SynCardia Certified Centers in Germany, France and the United States.
"Surpassing 1,000 implants is a milestone achievement for the Total Artificial Heart, which is rapidly becoming the new standard of care for end-stage biventricular failure," said Michael Garippa, SynCardia CEO/President and Chairman. "The Total Artificial Heart would not be where it is today without the leadership of hospitals like the University of Arizona, VCU, La Pitié in Paris and the Heart & Diabetes Center in Bad Oeynhausen. These centers have not only been avid supporters and users of the Total Artificial Heart for years, but have also rapidly adopted and deployed the new Freedom® portable driver for discharging stable patients home."
There are currently 56 SynCardia Certified Centers worldwide, with an additional 34 hospitals in the process of completing SynCardia's Certification Program. In 2011, 29 new centers signed up to undergo certification. In addition, many world-renowned transplant programs performed their first implants of the Total Artificial Heart last year, including NewYork-Presbyterian/Columbia, Texas Heart Institute, Texas Children's Hospital, Keck Hospital of the University of Southern California, Florence Nightingale Hospital in Istanbul, Turkey, and Papworth Hospital in the United Kingdom.
Four of the most experienced SynCardia Certified Centers account for more than half of the 1,000 implants performed thus far:
- La Pitié-Salpêtrière (213 implants) – La Pitié-Salpêtrière in Paris, France, is the most experienced SynCardia Certified Center in the world. This hospital has been implanting the Total Artificial Heart since 1986.
- The University of Arizona Medical Center (117 implants) – UMC in Tucson, AZ, is the most experienced SynCardia Certified Center in the U.S., having performed more than 100 implants of the Total Artificial Heart. Originally used as a permanent replacement heart, in 1985, UMC became the first hospital to successfully use the Total Artificial Heart as a bridge to transplant. The hospital played a critical role in the 10-year pivotal clinical study of the Total Artificial Heart that resulted in FDA approval in 2004.
- Heart & Diabetes Center NRW (154 implants) – The Heart & Diabetes Center NRW in Bad Oeynhausen, Germany, has more experience than any other hospital in discharging stable Total Artificial Heart patients home. From 2003-2006, this center pioneered the clinical study of the European portable driver, which resulted in CE approval and demonstrated that stable Total Artificial Heart patients could be safely discharged from the hospital to wait for a matching donor heart at home. This driver served as the "proof of concept" for the current Freedom portable driver, which is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.
- Virginia Commonwealth University Medical Center (61 implants) – VCU Medical Center in Richmond, VA, has achieved record patient outcomes with the Total Artificial Heart since it first began implanting the device in 2006. Of the 61 patients who have been implanted with the Total Artificial Heart at VCU, 90% have either have been transplanted or are currently on support awaiting a transplant.
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 1,300 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 175 patients, accounting for over 100 years of support.