For almost two months after the implant surgery, Gonzalez continued to produce no urine, so she was scheduled for surgery on Jan. 2 to receive a permanent catheter. However, on Jan. 1, she began making urine.
"Even I had started to lose hope," said Dr. Morales. "And now, she has normal function to her kidney. This experience has made me very optimistic that many of the livers and kidneys that fail due to heart disease could actually be recoverable with the total artificial heart. Every time we put in this device, we learn something new."
, Cincinnati Children's received approval from the FDA to switch Gonzalez to the
Freedom® portable driver
, the world's first wearable power supply for the SynCardia Total Artificial Heart. The Freedom driver will allow Gonzalez, who feels healthier than she has in years, to leave the hospital and return home for the first time since October.
"I keep telling her that I don't know what God's plan is, but there is a plan," said Gonzalez's mother,
. "And she just has to keep pushing through."
The Freedom driver is CE approved for use in
and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.
Read the feature story on Gonzalez published in the Cincinnati Enquirer at
CAUTION – The Freedom portable driver is an investigational device, limited by United States law to investigational use.
About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (
) 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 SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure). There have been more than 1,100 implants of the Total Artificial Heart, accounting for more than 300 patient years of life.
Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at
SynCardia Certified Centers
. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.
Forbes Ranks SynCardia #69 Among "America's Most Promising Companies"
issue, Forbes selected SynCardia as one of "America's Most Promising Companies" for the second consecutive year. On the list of 100 privately held, high-growth companies with bright futures, SynCardia was selected #69, moving up eight spots from its #77 ranking last year. See the full list of SynCardia Awards & Recognition
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