Press Release:
SynCardia Systems, Inc., Manufacturer of CardioWest™ Artificial Heart,
Promotes Mike Gaul to Chief Operating Officer
Gaul’s 30 Years in Medical and Robotic Manufacturing Key to Development of 50cc Artificial Heart
and Family of Ventricular Assist Devices

TUCSON, Ariz. – Oct. 16, 2007 – Rodger Ford, president and CEO of SynCardia Systems, Inc., announced today that Mike Gaul has been promoted to chief operating officer.
“Mike’s extensive experience in medical and high-tech manufacturing is one of the driving forces behind our future family of pulsatile devices, which includes a 50cc artificial heart designed for women/smaller adults,” Ford said. “All of these products are designed to be powered by our universal driver system that is intended for use in the hospital and for discharge. SynCardia is currently working with the FDA to make this driver available.”
SynCardia is the manufacturer of the CardioWest™ temporary Total Artificial Heart (TAH-t), the only FDA and CE approved temporary artificial heart in the world. Originally designed as a permanent replacement heart, the CardioWest artificial heart is currently approved as a bridge-to-transplant for patients dying from end-stage biventricular failure.
“There is growing demand by the world’s top transplant centers for the CardioWest artificial heart. It has the highest bridge-to-transplant success rate and the highest cardiac output of any approved device. By expanding SynCardia’s production capabilities, we are keeping up with demand for the artificial heart and our future family of devices to combat heart failure,” Gaul said.
In the pivotal clinical study of the CardioWest artificial heart, published in the New England Journal of Medicine (NEJM 2004; 351: 859-867), 79 percent of patients receiving the artificial heart survived to transplant, the highest survival rate for any heart device in the world.
Gaul joined SynCardia as vice president of operations in Oct. 2005. Prior to joining SynCardia, Gaul was vice president of operations for Ventana Medical Systems. Ventana Medical is one of the world’s leading developers and manufacturers of medical diagnostic instrument and reagent systems for use in slide-based diagnosis of cancer and infectious disease. Ventana provides equipment to 55 countries.
Prior to Ventana, Gaul was general manager of the Vanguard Automation plant in Tucson, Ariz., a division of Robotic Vision Systems, Inc. (RVSI). RVSI manufactured million dollar equipment used in the manufacturing of high-tech integrated circuits.
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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
SynCardia temporary CardioWest™ Total Artificial Heart.


