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  • Highest bridge to human heart transplant rate of any approved heart device, 79%
  • Nearly 1,300 implants account for more than 350 patient years on the Total Artificial Heart

Patient Recovery:
The Sickest Patients Recover Rapidly

According to data from INTERMACS (Interagency Registry for
Mechanically Assisted Circulatory Support), 90% of patients who
receive the SynCardia temporary Total Artificial Heart 
are in the two sickest categories prior to implant (see chart):

  1. Critical Cardiogenic Shock (Crash & Burn)
  2. Progressive Decline (Sliding Fast)
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Gray to Pink

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The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles to help vital organs recover faster.

Soon after implantation, the Total Artificial Heart’s high blood flow helps turn patients from a sickly gray to a healthier pink.

When a donor heart becomes available, these patients are in much better condition to receive their transplant than they were prior to receiving the Total Artificial Heart.

 

 

Patient Ambulation

Approximately 65% of the core Total Artificial Heart patients were out of bed by the 5th day after implant.
Two weeks after implant, 60% of core patients were walking more than 100 feet.

The following statistics are from the FDA Summary of Safety and Effectiveness for the
SynCardia Total Artificial Heart:

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Source: FDA Summary of Safety and Effectiveness, pages 18 & 19 
http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030011b.pdf
›› download 

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Cardiac Index*

Prior to implant, patients in need of the Total Artificial Heart had a baseline cardiac index of ≤ 2.0 L/min/m2 which is
considered critical cardiogenic shock. Following implantation of the Total Artificial Heart, the patient’s cardiac index immediately increased to an average of 3.0 L/min/m2.

 

 
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End Organ Recovery*

Within two weeks of Total Artificial Heart implant, liver function had returned to normal and kidney function had improved significantly, trending to normal.

 

 

*Source for charts: FDA Summary of Safety and Effectiveness, page 20, 23 and 24
http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030011b.pdf ›› download

 

 

NEXT ›› Eliminates Native Heart Complications

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

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