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SynCardia Systems, Inc.

Press Release:

1st U.S. Total Artificial Heart Patient Discharged Home Using Freedom® Driver Receives Dual Transplant

Charles Okeke Receives New Donor Heart & Kidney after 864 Days of Life with SynCardia's Total Artificial Heart

Charles Okeke received a dual heart and kidney transplant on Jan. 15, 2011, after 864 days of life with the SynCardia temporary Total Artificial Heart. Charles Okeke received a dual heart and kidney transplant on Jan. 15, 2011, after 864 days of life with the SynCardia temporary Total Artificial Heart. TUCSON, Ariz. – Feb. 15, 2011 – On Jan. 15, after 864 days of life with the SynCardia temporary Total Artificial Heart, Charles Okeke received a dual heart and kidney transplant at Mayo Clinic Hospital in Phoenix. Okeke made headlines in May 2010 when he became the first Total Artificial Heart patient in U.S. history to leave the hospital without a human heart. Okeke was able to return home as part of an FDA-approved Investigational Device Exemption (IDE) clinical study of the 13.5 lb Freedom® portable driver.

On Sept. 3, 2008, Okeke was implanted with the SynCardia Total Artificial Heart after his body rejected his previous donor heart transplant he'd received at age 30. For more than 600 days, Okeke 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, Okeke'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 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. During a historic moment on May 3, 2010, Okeke was discharged from Mayo Clinic Hospital wearing the Freedom driver in a backpack. He returned home to his wife Natalie and their three children to wait for a matching donor heart, and was supported by the Freedom driver for a total of 253 days.

Because of stress on his kidneys following his first heart transplant, it was optimal to do a combined heart/kidney transplant. This was only the third time in the world that a patient was bridged to a dual heart and kidney transplant with the Total Artificial Heart.

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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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