Press Release:

CLICK IMAGE TO ENLARGE: University Hospital of Nantes: Long Term Results After SynCardia Total Artificial Heart Support: Monocentric Experience with 46 Patients

TUCSON, Ariz. – Nov. 18, 2010 – On Oct. 17, Dr. Jean Christian Roussel from the Thorax Institute at University Hospital of Nantes presented the center's 18-year experience with the SynCardia temporary Total Artificial Heart at the Acute Cardiac Care 2010 medical meeting in Copenhagen, Denmark. The aim of the single center, retrospective study was to assess both the comorbidity and survival of patients awaiting heart transplants while supported by SynCardia's Total Artificial Heart.

The study's authors concluded that the SynCardia Total Artificial Heart "is an excellent bridge-to-transplant device for patients with biventricular failure. Our study demonstrates excellent safety, reliability and efficiency. Exceptional outcome after transplantation underlines its capacity to aid in end-organ recovery."

The study included 46 patients who received the Total Artificial Heart from 1990 to April 2008. Seventy-two percent (33) of these Total Artificial Heart patients were bridged to transplant. At one year post-transplant, 88% of these patients were alive, and at five years, 78%. The overall survival for all patients who received the Total Artificial Heart at five years was >55%.  

Duration of support was 1 to 502 days with a mean of 113± 106 days. Of the 13 patients who died during support, the leading cause of death was multi-organ failure (6). No device malfunctions led to patient death. Adverse events included stroke in 4 patients and infections in 37 patients.

The mean age at time of implantation was 46 (±9.8) and 96% (42) of patients were men. Idiopathic or dilated cardiomyopathy was the pre-implant diagnosis in 43.5% (20) of patients and ischemic cardiomyopathy in 43.5% (20) of patients.

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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, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 1,000 implants of the Total Artificial Heart, accounting for more than 250 patient years of life.

Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

For additional information, please visit: http://www.syncardia.com
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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660