The CardioWest™ temporary Total Artificial Heart

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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.


SynCardia promotes Mike Gaul to COO.

“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, as well as 10cc, 30cc and 60cc ventricular assist devices,” 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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Media Contact:
SynCardia Systems, Inc.
Director of Communications
Don Isaacs
Cell: 520-955-0660

About the CardioWest™ temporary Total Artificial Heart
The CardioWest™ TAH‑t is a pneumatic, biventricular, implantable bridge-to-transplant system for full cardiac replacement, taking the place of the failing heart in patients at imminent risk of death. The device offers full circulatory support, the shortest blood path and exposure to artificial surfaces, and the highest level of cardiac output when compared with other artificial heart systems previously tested. With the CardioWest™ TAH‑t, patients become better candidates for eventual transplantation and have post-transplant survival rates equal to that of non-device cardiac recipients.

About SynCardia Systems
Founded in 2001, SynCardia Systems is the developer of biomechanical cardiac replacement and assist devices. Its CardioWest™ temporary Total Artificial Heart (TAH‑t) is designed for severely ill patients with end-stage congestive heart failure. The device serves as an in-hospital bridge-to-transplantation for patients at imminent risk of death. SynCardia Systems is based in Tucson, Arizona and is on the Web at http://www.syncardia.com.

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