Regulatory Approvals
SynCardia temporary Total Artificial Heart
North America:
- FDA Approval PDF
- Health Canada Notice
- Health Canada License PDF
- FDA Approval PDF
- Health Canada Notice
- Health Canada License PDF
Indication: For use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
›› visit Total Artificial Heart
Implant Drivers
Companion Driver System*
- CE Mark
"Big Blue" Hospital Driver
- FDA
- Health Canada
- CE Mark
Discharge Drivers
Freedom® driver system**
- CE Mark
- FDA Investigational Device Exemption (IDE) clinical study
"Proof of Concept" Portable Driver
- CE Mark
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*CAUTION – The Companion Driver System is CE approved for use in Europe. It is not FDA approved for use in the U.S.
**CAUTION – The Freedom® driver system is an investigational device, limited by United States law to investigational use.
SynCardia
Total Artificial Heart
Characteristics:
- Replaces both ventricles
- No surgical pocket required
- For use in patients with a BSA of 1.7 m² or greater
- Highest cardiac output through both ventricles - up to 9.5 L/min
- Stroke volume is 70 ml
- Weighs 160 grams
- Blood flow path is the same as the human heart
- Shortest blood path (< 20 cm) of any mechanical circulatory support device
NEXT ›› Reimbursement
*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.
SynCardia temporary CardioWest™ Total Artificial Heart.
