SOURCE: SynCardia Systems, Inc.

SynCardia Systems, Inc.

July 14, 2011 07:55 ET

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

TUCSON, AZ--(Marketwire - Jul 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... read article

"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.

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, 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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