Thursday, July 28, 2011

40 New Hospitals Have Joined SynCardia's Certification Program to Implant Total Artificial Heart During Past Year

TUCSON, AZ--(Marketwire - Jul 28, 2011)SynCardia Systems, Inc. (, the privately-held manufacturer of the SynCardia temporary Total Artificial Heart, announced today that it has nearly tripled its first-half sales from 2010, posting its first quarterly and first-half profit in company history.
"There are only two companies making money in the mechanical circulatory support industry right now," said Michael Garippa, SynCardia CEO/President. "SynCardia and Thoratec. The Total Artificial Heart continues to become the standard of care for end-stage biventricular heart failure. In the past few weeks, half a dozen world-renowned transplant programs have completed SynCardia Certification and performed their first implants of the Total Artificial Heart. These centers have achieved excellent patient outcomes thus far, especially considering how sick these patients were prior to implant."
During the past year, 40 hospitals have enrolled in SynCardia's Certification Program to implant the Total Artificial Heart. SynCardia is currently conducting an FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom® driver, the first U.S. portable driver designed to power SynCardia's Total Artificial Heart both inside and outside the hospital. A total of 22 patients have been enrolled so far in the study. Of these patients, 19 have reached study end points of heart transplantation or 90 days of support on the Freedom driver. Twelve have been discharged, which is 40% of the 30 required by the FDA.
The Freedom driver, which is also CE approved for use in Europe, has supported a total of 50 patients worldwide. The most recent patient was transferred to the Freedom driver on July 21, at the Heart & Diabetes Center NRW in Bad Oeynhausen, Germany.
CAUTION - The Freedom® driver is an investigational device, limited by United States law to investigational use.
About the SynCardia temporary Total Artificial HeartSynCardia Systems, Inc. (Tucson, AZ) is the privately-held 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 Total is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. More than 900 implants account for more than 210 patient years of life.
Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end-stage biventricular failure. The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.
In March 2011, Fast Company magazine ranked SynCardia #20 among the World's 50 Most Innovative Companies "for giving mobility to artificial heart recipients." Also in March, the longest running health and wellness series on public television, "Healthy Body, Healthy Mind," produced a 30-minute program featuring SynCardia's Total Artificial Heart. View here
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