Press Release:

TUCSON, Ariz. – Dec. 8, 2009 – SynCardia Systems, Inc. announced today that MasterControl has been selected as the new quality management system for the Food and Drug Administration (FDA). MasterControl also provides the quality management system for SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart.

“The FDA will find a familiar system at SynCardia,” said Rodger Ford, SynCardia president and CEO. “We reviewed more than 30 quality management systems before finally selecting MasterControl in 2005. Since the validation and launch of the software in 2006, it has been the electronic backbone of all SynCardia quality documents.”

MasterControl will be used by the FDA’s Office of Regulatory Affairs (ORA) agencies that are engaged in field investigations enforcement and scientific laboratory analysis of field samples. The system will be implemented across the United States, in regional offices, district offices, laboratories and headquarters.

“At SynCardia, MasterControl has allowed a small group of people to achieve extraordinary results,” said Ford. “We have only 42 employees, but through MasterControl, we touched 5,500 documents last month. This system allows us to be efficient, accountable and responsive so that we can focus on the needs of our customers… patients and physicians around the world.”

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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.

For additional information, please visit: http://www.syncardia.com
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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660