The Title of the Video Would Go Here

 

The Only BTT Device that Eliminates the
Symptoms & Source of Heart Failure…

BACKGROUND: Since 1990 the supply of donor hearts has been flat, and in some cases has declined,
while the incidence of heart failure has continued to escalate. Donor hearts are in short supply
which causes a majority of patients to need a bridge to transplant (BTT.)

HeartTransplantBY

WHICH DEVICE: There is only one approved BTT device that eliminates the symptoms and source of heart
failure: The SynCardia temporary Total Artificial Heart.

  • Similar to a heart transplant the SynCardia Heart replaces the two native ventricles and four heart valves
  • Unlike a donor heart the SynCardia Heart is immediately available at 93+ SynCardia Certified Centers
thiollet-330wOn Aug. 5, 2013, Frederic Thiollet surpassed two years of support with the SynCardia Total Artificial Heart. In the Shoulder Bag he's holding is the Freedom®<br> portable driver, which powers his Total Artificial Heart. The Backpack on the ground contains his back-up Freedom driver and extra batteries.

INDICATION: For use as a BTT for transplant eligible patients at risk of imminent death from end-stage biventricular failure caused by:

Pediatric & adult congenital conditions Cardiomyopathy: Persistent ventricular tachycardia - Restrictive Refractory cardiogenic shock - Infiltrative Transplant rejection - Dilated Acquired VSD - Hypertrophic Cardiac amyloidosis

  • Pediatric & adult congenital conditions     
  • Cardiomyopathy:
    - Restrictive
    - Infiltrative
    - Hypertrophic
    - Dilated
  • Persistent ventricular tachycardia  
  • Refractory cardiogenic shock   
  • Transplant rejection    
  • Acquired VSD
  • Cardiac amyloidosis

FREEDOM® driver: Stable patients who meet discharge criteria can wait for their donor heart at home with the wearable Freedom portable driver which powers their SynCardia Heart. The Freedom is approved by Health Canada & has the CE Mark for Europe. In a letter dated October 21, 2013, the FDA determined that the Freedom PMA supplement is approvable with submission of additional information. SynCardia is cautiously optimistic for PMA approval during Q1 2014.

WATCH THE VIDEO: INTERMACS Level 1 Patients & Biventricular Failure

1,250+ implants of the world’s only approved Total Artificial Heart accounts for 335+ patient years of support

CAUTION – The Freedom 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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