The Title of the Video Would Go Here

  • Highest bridge to human heart transplant rate of any approved heart device, 79%
  • Over 1,350 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 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.

  • FDA approval: October 15, 2004
  • European CE Mark: September 19, 1999
  • Heatlh Canada: October 27, 2005

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

Destination Therapy
The 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 SynCardia to conduct an IDE clinical study to support FDA approval of 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

  • Life-threatening non-reversible biventricular heart failure
  • Not eligible for cardiac transplant
  • Body surface area (BSA) ≥ 1.7m² or adequate T10 measurement

 

children-silhouette50cc Total Artificial Heart*

The 50cc SynCardia Total Artificial Heart is intended to fit most women, adults of smaller stature and many adolescents.

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

  1. Bridge to transplant in adult patients
  2. Bridge to transplant in pediatric patients
  3. Compassionate use

Patient Selection Criteria

  • Life-threatening non-reversible biventricular heart failure
  • BSA below 1.85m² and/or adequate T10 measurement

 

*The 50cc Total Artificial Heart is designed for use as a bridge to transplant in patients of smaller stature, including women, smaller adults 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.

Following the 70cc destination therapy study & the 50cc bridge to transplant study, SynCardia will pursue a Destination Study of the 50cc heart with adult patients.

Caution: the 50cc TAH is an investigational device, limited by federal law to investigational use.

 

NEXT ›› Clinical Trials

 

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

FREE News Sign-Up

3538727_sBe Among the First to
Receive SynCardia News

... right in your email box