The mobility that the Freedom driver allows is a great benefit to patients who receive the SynCardia Total Artificial Heart. Zack will be able to go home and enjoy his life, rather than waiting months in a hospital room for a donor heart.
Tucson, AZ (PRWEB) March 21, 2012
SynCardia Systems, Inc., manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that on March 5, University of Kentucky Medical Center (UK) in Lexington discharged its first patient to be implanted with the SynCardia temporary Total Artificial Heart. Zack Poe, 20, is the first patient in the state to leave the hospital to wait for a matching donor heart at home using the Freedom® portable driver to power his Total Artificial Heart.
"The mobility that the Freedom driver allows is a great benefit to patients who receive the SynCardia Total Artificial Heart," said Dr. Jay Zwischenberger, chair of the UK Department of Surgery. "Zack will be able to go home and enjoy his life, rather than waiting months in a hospital room for a donor heart."
Zack’s journey began on Jan. 2, 2012, when he went to the doctor for an ulcer and was referred to an emergency room. After being diagnosed with pneumonia, he was given two liters of fluid, which resulted in immediate swelling. Doctors started Zack on medication and performed an ECHO to see what was wrong. The ECHO showed that Zack's ejection fraction -- a measurement of how much blood the heart pumps out to the body during each beat -- was less than 10 percent. In a healthy individual, it is usually 55 to 75%. Zack was referred to UK for consideration of advanced treatment options. About a week and a half after his initial diagnosis, his liver began to fail.
"Apart from his heart failure, Zack is a strong, healthy young man," said Dr. Charles Hoopes, director of the UK Heart and Lung Transplant Program and the Mechanical Cardiac Support Program. "But because of the severity of the heart failure, we felt he was the perfect candidate to receive the Total Artificial Heart while he waits on an appropriate donor heart."
To save Zack’s life, UK Medical Center set a record as the fastest hospital to complete all four phases of certification required to implant the Total Artificial Heart, discharging Zack home just 25 days after beginning the certification process.
"The operation went really smoothly. Zack was off the breathing tube the next day and was up and walking around within several days and has had a remarkable recovery," said UK surgeon Dr. Mark Plunkett, chief of Cardiothoracic Surgery and the co-director of the Linda and Jack Gill Heart Institute.
When doctors first told Zack about the Total Artificial Heart, he said he was receptive to the idea because it would keep him healthy enough until he could receive a heart transplant.
“I feel a million times better. Because of the outflow volume, I’ve been able to walk longer without pain than I have in months," said Zack.
A second UK patient was implanted with the Total Artificial Heart on Feb. 29 and is doing well. Dr. Hoopes said they hope to perform six implants a year, with an ultimate goal of 10 to 12 annually.
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.
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. (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, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 1,000 implants of the Total Artificial Heart, accounting for more than 250 patient years of life.
Similar to a heart transplant, SynCardia's 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 and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that 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.
SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. 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.