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SynCardia Systems, Inc.

Press Release:

1st Clinical Experience Using Freedom® Portable Driver to Power SynCardia's Total Artificial Heart Published in Journal of Heart and Lung Transplantation

SynCardia Certified Center Has Transferred Six Total Artificial Heart Patients to Freedom Driver While Awaiting Heart Transplantation

The Freedom® portable driver is CE approved to power SynCardia’s Total Artificial Heart in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. The Freedom® portable driver is CE approved to power SynCardia’s Total Artificial Heart in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. TUCSON, Ariz. – July 14, 2011 – SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart  (TAH-t), announced today that an article reporting the first use of the Freedom® portable driver with a Total Artificial Heart patient was published in the July issue of the Journal of Heart and Lung Transplantation.

"TAH-t use has been limited by the large operating console for the driver system that requires patients to remain hospitalized until transplantation," wrote the article's authors. "The Freedom driver allows clinically stable patients to await a donor heart as an outpatient."

The patient, 41, was implanted with SynCardia's Total Artificial Heart on Sept. 3, 2008, after his body rejected the donor heart he'd received at age 30. For more than 600 days, he was confined to the hospital by the only FDA-approved driver for powering the Total Artificial Heart, 418-lb "Big Blue." Due to the previous transplant, the patient's body produced antibodies that made it challenging for him to receive a matching donor heart.  

In March 2010, SynCardia received approval from the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom driver, the first U.S. portable driver designed to power the Total Artificial Heart both inside and outside the hospital. On May 3, 2010, this patient was discharged from the hospital using the Freedom driver to wait for a matching donor heart at home with his wife and children. He was supported by the Freedom driver for a total of 253 days before receiving a dual heart and kidney transplant on Jan. 15, 2011.

"The success of our first patient to be discharged home and then undergo transplantation is encouraging," concluded the article's authors. "Out-of-hospital management of the patient with a TAH-t appears feasible, and consideration for use of this device for longer-term applications may be held in the future."

To date, the hospital has transferred six Total Artificial Heart patients to the Freedom portable driver while awaiting heart transplantation. The Freedom driver is also CE approved for use in Europe.

CAUTION – The Freedom® portable driver is an investigational device, limited by United States law to investigational use.

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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 temporary 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.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

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