Two Sizes Designed to Fit Most Patients
70cc SynCardia Total Artificial Heart
The 70cc SynCardia Total Artificial Heart fits a majority of men and some women. It is designed for use in patients with a body surface area of 1.7m² or greater or adequate T10 measurement.
Bridge to Transplant Indication: The SynCardia Total Artificial Heart is approved for use as a bridge to donor heart transplant in cardiac transplant-eligible candidates at risk of imminent death from end-stage biventricular failure.
- FDA approval: Oct. 15, 2004
- European CE Mark: May 16, 2005
- Health Canada: Oct. 27, 2005
The FDA has granted a Humanitarian Use Device (HUD) designation for the 70cc Total Artificial Heart used for destination therapy (DT) in adults.
The FDA has also approved an Investigational Device Exemption (IDE) clinical study to support FDA approval of a Humanitarian Device Exemption (HDE) application. ›› See Investigational Use Studies
50cc SynCardia temporary Total Artificial Heart
The 50cc SynCardia Total Artificial Heart is intended to fit women, men of smaller stature and adolescents. It is designed for use in patients with a BSA of 1.2m² through 1.85m² with adequate T10 measurement or adequate room in the chest as determined by 3D imaging assessment or by other standard clinical assessments.
- In Europe, the 50cc SynCardia Total Artificial Heart has the CE Mark for use as a bridge to donor heart transplant.
- In the United States, the 50cc Total Artificial Heart is undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study as a bridge to donor heart transplant. ›› See Investigational Use Studies
CAUTION – In the United States, the SynCardia 50cc TAH-t is an investigational device, limited by federal law to investigational use.
CAUTION – In the United States, the use of the SynCardia 70cc TAH-t for destination therapy is investigational.