SynCardia Systems has received a Humanitarian Use Device (HUD) designation for its total artificial heart to be used for destination therapy. While the system was already FDA approved for bridging the period to transplant, the designation means it can now also be used in end-stage heart failure patients not eligible for cardiac transplantation as a permanent solution for the rest of their lives. According to the company this group comprises up to 4,000 U.S. patients each year.
The SynCardia replaces both ventricles, weighs 160 grams and has a cardiac output of up to 9.5 L/min. The SynCardia artificial heart originally received FDA approval in 2004 as a bridge to transplant and, impressively, has already supported one patient for almost four years prior to transplantation.
Destination therapy has become an option because of the portable Freedom driver, which powers the artificial heart and about which we have reported several times before. The 13.5-pound driver substitutes the old 400-pound driver that kept patients hospital-bound. One hurdle still remains though, before patients can go home with the device, as the Freedom driver itself is still an investigational device currently undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study.
Flashbacks: The CardioWest™ TAH-t; A New Driver System for CardioWest Artificial Heart; Syncardia’s Freedom Mobile Artificial Heart Driver Gets CE Mark; Syncardia’s Freedom Artificial Heart Driver Going to Trial in US
Press release: SynCardia’s Total Artificial Heart Receives HUD Designation
for Destination Therapy from FDA…
Product page: SynCardia Total Artificial Heart…
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