FDA Grants HUD Designation for SynCardia’s Total Artificial Heart as a Destination Therapy

Approval of HDE Will Allow Up to 4,000 U.S. Patients Not Eligible for Transplant to Receive the Total Artificial Heart on a Permanent Basis

 

April 17, 2012

The U.S. Food and Drug Administration (FDA) has approved a humanitarian use device (HUD) designation for the SynCardia temporary Total Artificial Heart to be used for destination therapy in addition to its current PMA approval as a bridge to transplant.

The FDA approval letter of the HUD request designates the Total Artificial Heart for use in U.S. patients “at risk of imminent death from non-reversible biventricular heart failure who are not eligible for cardiac transplant and have a body surface area (BSA) of ≥ 1.7m2.”

Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart received FDA approval in 2004 as a bridge to transplant for transplant-eligible patients dying from end-stage biventricular heart failure. Currently, the longest a patient has been supported with the Total Artificial Heart is 1,374 days (almost four years) prior to receiving his heart transplant.

During 30 years of use, the valves in the SynCardia Total Artificial Heart have never failed. The diaphragm has a failure rate of less than 1 percent over more than 1,000 implants (2,000+ diaphragms).

*The Freedom portable driver is the world’s first wearable power supply for SynCardia’s Total Artificial Heart. It is CE approved for use in Europe and undergoing an FDA-approved investigational device exemption (IDE) clinical study in the United States.

 For more information: www.syncardia.com