70cc Total Artificial Heart

The 70cc SynCardia temporary Total Artificial Heart fits a majority of men and some women. It is designed for use in patients with a Body Surface Area (BSA)* of 1.7m² or greater.

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 70cc Total Artificial Heart to be used for destination therapy in addition to its current approval as a bridge to transplant.

Patient Selection Criteria

• At risk of imminent death from non-reversible biventricular heart failure
• Not eligible for cardiac transplant
• Body surface area (BSA) greater than or equal to 1.7m²

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.

50cc Total Artificial Heart

The 50cc Total Artificial Heart 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.

Patient Selection Criteria

• At risk of imminent death from non-reversible biventricular heart failure
• Not eligible for cardiac transplant
• Have a BSA between 1.2 and 1.79m²

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).

The next step is for the FDA to approve a Humanitarian Device Exemption (HDE) application for each indication of the 50cc Total Artificial Heart. Once approved, the HDEs will allow up to 4,000 U.S. patients annually to receive the 50cc Total Artificial Heart on a permanent basis as destination therapy, and an additional 4,000 pediatric patients to receive the device as a temporary bridge to transplant.

*BSA (m²) = ([Height (cm) x Weight (kg)] / 3600)^½

NEXT ›› FDA Clinical Trial