TUCSON, Ariz., April 1, 2014 /PRNewswire/ -- Nine 'best of the best' SynCardia Certified Centers were honored by SynCardia Systems, Inc., for their use of the SynCardia temporary Total Artificial Heart, the world's first and only FDA, Health Canada and CE approved Total Artificial Heart, and the Freedom® portable driver that powers it.
Most SynCardia patients are considered the sickest of the sick. "Crash and Burn" and "Progressive Decline" are used to describe these INTERMACS 1 and 2 end-stage heart-failure patients who need "definitive intervention" within days or hours to survive.
According to data published in the New England Journal of Medicine1 from the 10-year pivotal clinical study that led to FDA approval, 79% of patients who received the Total Artificial Heart were bridged to transplant of a donor heart. This is the highest bridge to transplant rate for any approved heart device in the world.
All patients who received SynCardia Heart implants in 2012 and 2013 at these centers were either bridged to a donor heart transplant or alive with SynCardia Heart support during those years. Many awaiting donor hearts are at home supported by the Freedom portable driver.*
- UCLA Medical Center, Los Angeles, CA
- Sentara Heart Hospital, Norfolk, VA
- A SynCardia Certified Center in Minnesota
For leadership in the use of the SynCardia Total Artificial Heart and Freedom portable driver:
- Cedars-Sinai Medical Center team, Los Angeles, implanted more SynCardia Hearts in a single year—23 in 2013—than any other SynCardia Certified Center.
- Evangelisches Krankenhaus Duisburg-Nord team, Germany, conducted 13 SynCardia Heart implants in 2013, more than any center outside of the United States.
- Stanford University Medical Center, Palo Alto, CA, implanted five SynCardia Hearts in 2013, its first year as a SynCardia Certified Center.
- University of Nebraska Medical Center, Omaha, implanted four SynCardia Hearts last year when it became a SynCardia Certified Center.
- Gazientep University Hospital, Turkey, implanted four SynCardia Hearts.
- Dr. H. Todd Massey and the University of Rochester Medical Center were recognized as emerging leaders for their commitment in strengthening their SynCardia Total Artificial Heart program and efforts to assist other SynCardia Certified Centers do the same. Dr. Massey is a surgical proctor for new centers doing their first SynCardia implant.
More than 400 SynCardia Total Artificial Heart implants have been performed since January 2011. The SynCardia Heart has provided almost 130,000 patient days of support in nearly 1,300 implants. The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 76 years old.
At only 13.5 pounds, the Freedom portable driver provides patients with almost unlimited mobility. It is pending FDA approval and is approved by Health Canada and the CE Mark for Europe. A majority of clinically stable patients are discharged with the Freedom driver to recover at home and in their communities as they wait for donor hearts.
Tops in Reliability
During 30 years of use, the valves in the SynCardia Total Artificial Heart have never failed. The diaphragm, which is responsible for pumping blood in and out of the ventricles, has a failure rate of less than one half of 1% for nearly 1,300 implants (2,600+ diaphragms).
>> Read Ceder Sinai's Press Release: Cedars-Sinai Heart Institute Sets New Standard for Most US Heart Transplants in a Year
*CAUTION – The Freedom portable driver is an investigational device, limited by United States law to investigational use.
1N Engl J Med 2004;351:859-67
About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held 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 heart failure affecting both sides of the heart (biventricular failure).
There have been nearly 1,300 implants of the Total Artificial Heart, accounting for more than 350 patient years of life on the device.
Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at 97 SynCardia Certified Centers worldwide with 39 others in the process of certification.
The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.
SOURCE SynCardia Systems, Inc.