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 SynCardia Systems, Inc.

SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary CardioWest™ Total Artificial Heart. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 180 patient years of life on the device. 

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.

For additional information, please visit: http://www.syncardia.com
or follow SynCardia on Twitter – @SynCardia_News

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