40 New Hospitals Join SynCardia's Certification Program to Implant Total Artificial Heart During Past Year
World's Only Approved Total Artificial Heart Growing into Standard of Care for End-Stage Biventricular Heart Failure
TUCSON, Ariz. – June 9, 2011 – SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, announced today that during the past year, 40 hospitals have enrolled in SynCardia's Certification Program to implant the world's only FDA, Health Canada and CE approved Total Artificial Heart.
SynCardia is currently certifying the company's first transplant centers in New York, Boston, Atlanta, Texas, Los Angeles and the Pacific Northwest, in addition to Great Britain, Lithuania and Israel.
"We are very excited to have renowned transplant centers adopt SynCardia's Total Artificial Heart technology, including Texas Children's Hospital, Brigham and Women's Hospital and Papworth Hospital," said Michael Garippa, President/CEO. "With the availability of the Freedom® portable driver, SynCardia's Total Artificial Heart is growing into the standard of care for patients dying from end-stage biventricular failure. We are working to bring the Total Artificial Heart to all major markets across the U.S. and the world."
Once currently enrolled hospitals complete the four-phase certification process, the number of U.S. SynCardia Certified Centers will double to 30, bringing the total number of centers worldwide to 70. In addition to the United States, there are currently SynCardia Certified Centers in Australia, Germany, France, Italy, Russia, Turkey, Austria and Canada.
The Freedom portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. Weighing 13.5 pounds, the Freedom driver is the first U.S. portable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is intended to allow stable Total Artificial Heart patients to be discharged from the hospital to wait for a matching donor heart at home and in their communities.
CAUTION – The Freedom® driver is an investigational device, limited by United States law to investigational use.
About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the SynCardia Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.
Janelle Drumwright, firstname.lastname@example.org, (520) 547-7463