SynCardia Total Artifical Heart
On May 3 2010, Mayo Clinic Arizona became the first hospital in U.S. history to discharge a patient implanted with the SynCardia temporary Total Artificial Heart to wait at home for a matching donor heart. Mayo Clinic is participating in an FDA Investigational Device Exemption (IDE) clinical study of the Freedom™ driver, the first ever U.S. portable driver designed to power SynCardia’s Total Artificial Heart both inside and outside the hospital.
Charles Okeke, 43, was implanted with the SynCardia Total Artificial Heart on Sept. 3, 2008, after his body rejected a previous donor heart transplant. For more than 600 days, Charles was confined to the hospital by the 418-lb hospital driver nicknamed “Big Blue” that powered his Total Artificial Heart.
SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 950 implants of the Total Artificial Heart, accounting for more than 230 patient years of life. In August 2010 as an industry first SynCardia launched a new online shop at
http://Shop.SynCardia.comApprovals
- US FDA
- Canadian TPD
- European CE