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SynCardia Systems, Inc.

Press Release:

SynCardia Recognizes 7 Certified Centers for Use of Total Artificial Heart and Freedom® Portable Driver

Company President Michael Garippa Presents Awards at Clinical Investigator Meeting for 13.5-lb Wearable Driver

French Total Artificial Heart patient Antonio Amoussou was discharged from La Pitié Hospital using the Freedom® portable driver on July 5, 2010. He received a matching donor heart on Jan. 2, 2011 French Total Artificial Heart patient Antonio Amoussou was discharged from La Pitié Hospital using the Freedom® portable driver on July 5, 2010. He received a matching donor heart on Jan. 2, 2011 TUCSON, Ariz. – April 28, 2011 – On April 13, SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, presented awards to seven SynCardia Certified Centers during its Clinical Investigator meeting in San Diego for its FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom® portable driver. The 13.5 lb Freedom driver, which is also CE approved for use in Europe, is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital.

Outstanding Outcomes Award
Recipient:
Dr. Vigneshwar Kasirajan & Team, VCU Medical Center (Richmond, VA)
Achievement:
The team at VCU, one of SynCardia's highest volume centers, saved the lives of 27 consecutive patients dying from end-stage biventricular failure with the Total Artificial Heart. All 27 patients have either been transplanted or are currently awaiting a matching donor heart on the device. VCU currently has five patients supported by the Freedom driver.

Freedom® Pioneer Award
Recipients:
Dr. Francisco Arabia & Team, Mayo Clinic (Phoenix, AZ)
Pr. Daniel Duveau & Team, University Hospital of Nantes (Nantes, France)
Prof. Pascal Leprince & Team, La Pitié Hospital (Paris, France)
Prof. Jan Gummert & Team, Heart & Diabetes Center NRW (Bad Oeynhausen, Germany)
Achievement:
These hospitals exhibited leadership in use of the Freedom portable driver to discharge stable Total Artificial Heart patients. Mayo Clinic discharged the first Total Artificial Heart patient using the Freedom driver in the U.S. and University Hospital of Nantes the first in Europe. La Pitié has performed more implants of the Total Artificial Heart than any other center in the world and the Heart & Diabetes Center NRW leads all European centers in Freedom driver use.

Best Launch Award
Recipients:
U.S. - INTEGRIS Baptist Medical Center (Oklahoma City, OK)
International - St. Vincent's Hospital (Sydney, Australia)
Achievement:
INTEGRIS and St. Vincent's were both recognized for their rapid use of SynCardia's Total Artificial Heart and Freedom driver. A month after performing it's first implant, INTEGRIS discharged its first patient using the Freedom driver. INTEGRIS performed two more implants soon after. St. Vincent's performed its first two implants within 13 days of each other. Both patients recovered rapidly and were switched to the Freedom driver within two weeks of implant. One patient has since been transplanted and the other is currently waiting for a matching donor heart. St. Vincent's has performed 5 implants overall.

CAUTION – The Freedom® portable driver is an investigational device, limited by United States law to investigational use. 

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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 temporary 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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