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SynCardia Systems, Inc.

Press Release:

1st SynCardia Total Artificial Heart Patient in U.S. History Discharged on the Freedom® Portable Driver

Father of Three Goes Home Using Freedom® Portable Driver after 600+ Days in the Hospital

On May 3, 2010, SynCardia Total Artificial Heart patient Charles Okeke, accompanied by his wife Natalie, leaves the hospital using the Freedom portable driver. On May 3, 2010, SynCardia Total Artificial Heart patient Charles Okeke, accompanied by his wife Natalie, leaves the hospital using the Freedom portable driver. TUCSON, Ariz. – May 27, 2010 – On May 3, a Phoenix-area SynCardia Certified Center became the first hospital in U.S. history to discharge a patient implanted with the SynCardia temporary Total Artificial Heart to wait at home for a matching donor heart. This hospital is participating in an FDA Investigational Device Exemption (IDE) clinical study of the Freedom® driver, the first ever U.S. portable driver designed to power SynCardia’s Total Artificial Heart both inside and outside the hospital.

Charles Okeke, 43, was implanted with the SynCardia Total Artificial Heart on Sept. 3, 2008, after his body rejected a previous donor heart transplant. For more than 600 days, Charles was confined to the hospital by the 418-lb hospital driver nicknamed “Big Blue” that powered his Total Artificial Heart.

Then, on March 26, 2010, SynCardia Systems, Inc., received conditional approval from the FDA to conduct an IDE clinical study of the Freedom portable driver in the U.S.

“When the Total Artificial Heart was implanted in 2008, I felt better than I had in years,” said Charles. “Now, through the IDE clinical study, I’m able to wait at home for a donor heart with Natalie, my wife of 12 years, and our three children ages 4, 6 and 11.”

Weighing only 13.5 lbs including two rechargeable, lithium-ion Onboard Batteries, the Freedom driver is designed to be carried by the patient in the Freedom Backpack or Shoulder Bag.

The IDE clinical study is approved to enroll 60 patients at up to 30 institutions. The IDE clinical study is intended to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and can be used safely at home.

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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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