Texas Heart Institute Implants 4 Total Artificial Hearts
in 12 Days
3 of 4 Patients Have Been Discharged Home Using Freedom® Portable Driver as Part of FDA Clinical Study
TUCSON, Ariz. – Oct. 6, 2011 – SynCardia Systems, Inc., manufacturer of the world's only FDA, Health Canada and CE approved Total Artificial Heart, announced today that Texas Heart Institute (THI) at St. Luke's Episcopal Hospital (SLEH) in Houston performed four implants of the SynCardia temporary Total Artificial Heart over a 12-day period beginning July 22.
"For patients who are out of options, these devices are absolutely critical. And in most cases, the patients see marked improvement in their quality of life and how well they feel," said Dr. Igor Gregoric, director of THI's Center for Cardiac Support and associate director of Cardiovascular Surgery and Transplant Research. "It is an extremely valuable tool."
In an email to SynCardia, Jennifer Kliesing, whose husband Jeremiah was the second patient to receive the Total Artificial Heart at THI, wrote:
"I can't thank SynCardia and all its staff enough. I know every wife says she loves her husband, but Jeremiah and I have always had something extra. I was terrified, several times, that I would go through the rest of my life without him, and SynCardia let him live... he's thrilled to be here. He is making plans to do several things as he's able... you should see the zest he has for life."
Three of the four Total Artificial Heart patients have been discharged from the hospital to wait for a matching donor heart at home using the Freedom® portable driver, the first wearable power supply for SynCardia's Total Artificial Heart. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.
The three patients who have been discharged include:
- Shawn Galloway, a 38-year-old mother who returned home just in time to go shopping for school clothes with her children
- Ken Woychesin, who had a heart attack at 26, a heart transplant at 34 and five years later, found himself in need of another transplant
- A 22-year-old man who had previously received a heart transplant at the age of 2 at THI
"We've come a long way since that first implant," said THI's founder Dr. Denton Cooley, who performed the world's first artificial heart implant in 1968. "I am proud that THI continues to lead the way in such technology to help patients."
CAUTION – The Freedom® portable driver is an investigational device, limited by United States law to investigational use.
SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart.
Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,350 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by over 190 patients, accounting for over 110 years of support.