TUCSON, Ariz.--(BUSINESS WIRE)--EKN Duisburg-Nord, a leader in treating heart failure, is the first device-only implantation program to reach 50 SynCardia Total Artificial Heart implants, which include both the 70cc and 50cc TAH-t sizes. Most SynCardia Certified Centers combine a device program with a heart transplant component.
“Our work has proven that the 50cc SynCardia TAH-t is meeting the needs of smaller patients,” says EKN Duisburg-Nord Prof. Dr. Reiner Körfer. “We are able to save lives and get these patients stable and strong enough for a donor heart transplant at another medical center.”
“With the smaller 50cc SynCardia Artificial Heart, we have been able to save women, men of small stature and many adolescents. The smaller SynCardia Artificial Heart is unique in its ability to address these underserved populations,” says Prof. Dr. Gero Tenderich, who has led EKN Duisburg-Nord’s SynCardia Total Artificial Heart program since 2011.
Like a heart transplant, the SynCardia Artificial Heart is the only approved device that eliminates end-stage biventricular (both sides) heart failure. This fatal condition results when the native heart’s two ventricles can no longer pump enough blood for a patient to survive.
Of EKN Duisburg-Nord’s seven implantations of 50cc SynCardia Total Artificial Hearts, 86% were in females. In comparison, 95% of the recipients of the center’s 43 70cc SynCardia Total Artificial Hearts were males.
This trend is similar for 50cc SynCardia TAH-t implants across all centers. Of all 50cc implants, females account for 67% of implants, while males account for 89% of implants of the 70cc version.
The 50cc SynCardia Heart is approved for use in Europe by the CE Mark and by Health Canada. It currently is in an FDA-approved clinical study for use in the United States. (CAUTION – In the United States, the 50cc SynCardia temporary Total Artificial Heart is an investigational device, limited by United States law to investigational use.)
About the SynCardia temporary Total Artificial Heart
SynCardia Systems, LLC in Tucson, Arizona, is a medical technology company focused on developing and manufacturing the SynCardia temporary Total Artificial Heart (TAH-t). The SynCardia TAH-t is an implantable system designed to assume the full function of a failed human heart in patients suffering from end-stage biventricular (both sides) heart failure.
The SynCardia TAH-t is the only total artificial heart that is commercially available in the United States, European Union and Canada for use as a bridge to donor heart transplantation.
More than 1,625 implants of the SynCardia Total Artificial Heart account for over 550 patient years of life on the device. Since January 2012 more than 600 SynCardia Hearts have been implanted.
The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 80 years old. The longest a patient has lived with a SynCardia Heart and received a successful donor heart transplant was nearly four years (1,373 days).
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged from the hospital and live at home and in their communities. The Freedom® portable driver has been used by more than 290 patients, accounting for over 190 patient years of support.