Regulatory Approvals

small-blue-tahSynCardia 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.

›› visit Total Artificial Heart

Implant Drivers

Companion Hospital DriverCompanion Driver System*

- CE Mark


 

Big Blue Hospital Driver"Big Blue" Hospital Driver

- FDA
- Health Canada
- CE Mark


›› visit Implant Drivers

Discharge Drivers

fdriverFreedom® driver system**

- CE Mark 
- FDA Investigational Device Exemption (IDE) clinical study  

Proof of Concept Portable Driver"Proof of Concept" Portable Driver

- CE Mark
-
-


›› visit Discharge Drivers


*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.

 

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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

›› The Total Artificial Heart

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NEXT ›› Reimbursement

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

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