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  • Highest bridge to human heart transplant rate of any approved heart device, 79%
  • Over 1,300 implants account for nearly 400 patient years on the SynCardia Total Artificial Heart

Two Sizes Intended to Treat Most Patients

adult-silhouette70cc 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.

Bridge to Transplant: Indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

  • FDA approval: Oct. 15, 2004
  • European CE Mark: May 16, 2005
  • Heatlh Canada: Oct. 27, 2005

Destination Therapy
The U.S. Food and Drug Administration (FDA) has approved a Humanitarian Use Device (HUD) designation for the 70cc Total Artificial Heart to be used for destination therapy. The next step is for the FDA to approve a Humanitarian Device Exemption (HDE) application. Once approved, the HDE will allow up to 4,000 U.S. adult patients annually who are not transplant-eligible to receive the 70cc Total Artificial Heart for destination therapy.

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

 

children-silhouette50cc Total Artificial Heart* - Under Development

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. 

IDE Clinical Study: SynCardia plans to conduct an Investigational Device Exemption (IDE) clinical study of the 50cc Total Artificial Heart in the U.S. The 50cc TAH study will feature three arms:

  1. Bridge to transplant in adult patients
  2. Destination therapy in adult patients
  3. Bridge to transplant in pediatric patients

Patient Selection Criteria

  • At risk of imminent death from non-reversible biventricular heart failure
  • BSA between 1.2 and 1.79m² and/or T10 measurement and LVEDD

*The 50cc Total Artificial Heart is designed for use as a bridge to transplant in patients of smaller stature, including women and adolescents.It has been designated as a Humanitarian Use Device (HUD) by the FDA for destination therapy in adults and as a bridge to transplant in pediatric patients. Prior to clinical study, an Investigational Device Exemption (IDE) application that includes each indication must be approved by the FDA.

 

NEXT ›› Clinical Trials

 

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

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