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SynCardia Systems, Inc.

Press Release:

‘Best of the Best’ SynCardia Certified Centers Earn Honors for Giving End-Stage Heart Failure Patients a Second Chance at Life

SynCardia Systems, Inc., Recognizes Outstanding Outcomes, Implant Leaders, Emerging Leaders & Fast Start Certified Centers.

Since his August 5, 2011 implant, Frederic Thiollet has been supported with the SynCardia Total Artificial Heart for 949 days as of April 1, 2014. In the Shoulder Bag he’s holding is the Freedom® portable driver, which powers his Total Artificial Heart. The Backpack on the ground contains his back-up Freedom driver and extra batteries. Since his August 5, 2011 implant, Frederic Thiollet has been supported with the SynCardia Total Artificial Heart for 949 days as of April 1, 2014. In the Shoulder Bag he’s holding is the Freedom® portable driver, which powers his Total Artificial Heart. The Backpack on the ground contains his back-up Freedom driver and extra batteries. TUCSON, Ariz. – April 1, 2014 – 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.

Outstanding Outcomes

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

Implant Leaders

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.

Fast Start

  • 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.

Emerging Leaders

  • 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 YearCedars-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

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About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the SynCardia Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

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