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SynCardia Systems, Inc.

Press Release:

Record Number of ISHLT Abstracts
Discuss SynCardia's Total Artificial Heart

Medical Meeting Presentations to Include Post-Market Surveillance Study Results and
Comparison of Survival to Transplant/INTERMACS Profile Among MCS Devices

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TUCSON, Ariz. – April 5, 2012 – SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that this year's annual meeting of the International Society for Heart & Lung Transplantation (ISHLT) being held April 18-21 in Prague, Czech Republic, features a record number of abstracts discussing the SynCardia temporary Total Artificial Heart.

"With more than 1,000 implants, use of the Total Artificial Heart worldwide is accelerating rapidly. During Q1, 26 hospitals implanted the Total Artificial Heart, 12 of which were new centers," said Michael Garippa, SynCardia Chairman/CEO/President. "The number of ISHLT presentations is a testament to the growing acceptance of the Total Artificial Heart as the new standard of care for end-stage biventricular heart failure."

Two key ISHLT presentations discussing the SynCardia Total Artificial Heart include: 

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  • "Translatable Performance with the Total Artificial Heart: The U.S. Post-Market Study"
    Session: Mini Oral Session: 4 Mechanical Circulatory Support II (1:15-2:45 p.m.)
    Date/Time: Friday, April 20 – 2:20 p.m.
    Location: Panorama Hall

    Purpose: The Total Artificial Heart (SynCardia Systems) was approved in the U.S. by the FDA in 2004 as a bridge-to-transplantation (BTT) for patients at imminent risk of death from irreversible biventricular failure. The original PMA study leading to regulatory approval was conducted from 1993 – 2002 at 5 medical centers with 58/81 (78%) of TAH implants performed at a single center. A BTT rate of 79.9% was achieved. The question remains as to the translatability of this outcome, and the general facility of use of the TAH, in the hands of multiple surgeons, across varying implanting medical centers. We report the results of the FDA-required post-market surveillance study (PMSS) examining the efficacy of the TAH in general use across the U.S.
      
  • Survival to Transplant in Patients Undergoing Mechanical Circulatory Support as Bridge: Retrospective Analysis of LVAD, BiVAD and TAH Strategy
    Session: Concurrent Session 43: VAD Bad (11:30 AM-12:45 PM)
    Date/Time: Saturday, April 21, 2012 - 11:42 AM
    Room: Meeting Hall I

    Purpose: Bi-ventricular support has historically shown poorer survival to transplant than LVAD alone. Survival studies, however, have generally not distinguished between those supported with the Total Artificial Heart (TAH) and other strategies for bi-ventricular support (BiVAD). This study compares survival to transplant among patients receiving BTT using BiVAD, LVAD or TAH support.
     

During ISHLT, on April 20, SynCardia is holding a Clinical Investigator's Meeting for the Freedom® portable driver, the world's first wearable power supply for the Total Artificial Heart. 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.

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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