100th SynCardia Total Artificial Heart
Implanted in 2013
Milestone Reached Three Months Earlier Than Record-Breaking 2012
TUCSON, Ariz. – July 25, 2013 – SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that as of July 18, a record-breaking 100 implants of the SynCardia temporary Total Artificial Heart have been performed by SynCardia Certified Centers in 2013. This milestone was achieved three months earlier than in 2012, when the 100th implant was performed on Oct. 16.
“2012 was a record-breaking year for SynCardia with 125 implants of the Total Artificial Heart at 54 SynCardia Certified Centers,” said Michael Garippa, SynCardia CEO and President. “Reaching 100 implants three months earlier than we did last year is a testament to our long-term growth trajectory, which will be close to tripling since 2009. We expect this growth to continue as more hospitals adopt the Total Artificial Heart as the new standard of care for end-stage biventricular heart failure.”
The 100th implant of the Total Artificial Heart was performed by Virginia Commonwealth University (VCU) Medical Center in Richmond, one of the most experienced SynCardia Certified Centers in the world. The surgery marked VCU Medical Center’s 75th Total Artificial Heart implant since becoming a SynCardia Certified Center in 2006.
“From January 2012 through the first seven months of 2013, there have been 230 implants of the Total Artificial Heart,” said Garippa. “This is nearly double the number of implants performed during the same 19-month period from 2010 to 2011, in which 120 implants were performed.”
SynCardia is currently awaiting a response from the FDA regarding its premarket approval supplement for the Freedom® portable driver, the world’s first wearable power supply for the Total Artificial Heart. To date, 140 patients have been supported by the Freedom portable driver worldwide, accounting for more than 68 patient years of support. Of these patients, 89 were discharged from the hospital to wait for a matching donor heart at home and in their communities.
The Freedom portable driver 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 175 patients, accounting for over 100 years of support.