Press Release:

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.

The 13.5 lb Freedom portable driver and the 418-lb “Big Blue” hospital driver for powering the SynCardia temporary 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 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 950 implants of the Total Artificial Heart, accounting for more than 230 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.

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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660