70cc SynCardia temporary Total Artificial Heart

Indication: For use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

HUD for Destination Therapy
On March 2, 2012, the U.S. Food and Drug Administration (FDA) approved a Humanitarian Use Device (HUD) designation for the SynCardia Total Artificial Heart to be used for destination therapy in addition to its current approval as a bridge to transplant.

The next step is for the FDA to approve a Humanitarian Device Exemption (HDE) application for the 70cc Total Artificial Heart. Once approved, the HDE will allow up to 4,000 U.S. patients annually who are not transplant-eligible to receive the 70cc Total Artificial Heart on a permanent basis.

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50cc Total Artificial Heart

The 50cc Total Artificial Heart is a smaller version of the 70cc Total Artificial Heart. It is designed for use in patients of smaller stature, including women and adolescents, who have a BSA between 1.2 and 1.79m².

HUD for Destination Therapy
On Jan. 15, 2013, the FDA approved a HUD designation for the 50cc Total Artificial Heart to be used for destination therapy in patients who are not eligible to receive a heart transplant.

HUD for Pediatric Bridge to Transplant
On Jan. 30, 2013, the FDA granted a HUD designation for the 50cc Total Artificial Heart to be used for the treatment of biventricular heart failure in pediatric patients with a BSA that can sufficiently accommodate the device (i.e. between 1.2 and 1.7m²).

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Drivers

Companion 2 hospital driver

- European CE Mark: July 25, 2011
- FDA approval: July 5, 2012

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Freedom® portable driver*

- European CE Mark: March 1, 2010
- Health Canada: May 25, 2011
- FDA Investigational Device Exemption (IDE) clinical study  
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*CAUTION – The Freedom® portable driver is an investigational device, limited by United States law to investigational use.