Press Release:

BOSTON – April 9, 2008 – On April 9-12, SynCardia Systems, Inc., manufacturer of the CardioWest™ temporary Total Artificial Heart (TAH-t), is unveiling the prototype of its new four-pound Companion II Driver, the next generation in its Companion Driver System series, at the 28th annual meeting of the International Society for Heart and Lung Transplantation (ISHLT).

“Weighing only four pounds, the Companion II is intended to be the smallest pneumatic driver for the artificial heart in the world,” said SynCardia President and CEO Rodger Ford. “You’ll never notice patients with the Companion II because it is designed to disappear into a fanny pack.”

Since July 17, 2006, stable CardioWest patients in Europe have enjoyed a much better quality of life than CardioWest patients in the U.S. because of the CE approved portable driver. Discharge drivers allow stable artificial heart patients to shop, travel and enjoy a quality of life comparable to people with human hearts. Discharge eliminates most in-hospital costs while these stable patients wait for a donor heart at home.

Today, U.S. CardioWest patients are confined to the hospital while they wait for a heart transplant because the only FDA-approved driver is the hospital-based, 400-pound “Big Blue.”

SynCardia will submit an application to the FDA this year to conduct an IDE clinical study of the Companion Drive System at 22 U.S. hospitals. SynCardia has been working with the FDA and CMS for more than a year to bring this new technology to its patients. The first Principal Investigator’s Meeting is April 10, at ISHLT.

The Companion Drive System is designed to be docked into the Companion Hospital Cart for use in the operating room and intensive care unit. Once the CardioWest artificial heart patient is stable, the Drive Unit is designed to be re-docked into the Companion Discharge Caddy for mobility around the hospital and recovery at home.

“The Companion Driver family offers us the opportunity to address the deficiencies in the spectrum of mechanical circulatory support,” Ford said. “These drivers are intended to support not only the world’s only temporary Total Artificial Heart, but also the SynCardia family of pulsatile devices that are currently under development.”

At ISHLT, SynCardia is also presenting a prototype of the 50cc artificial heart currently being developed, along with the Companion II Driver.

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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 1,000 implants of the Total Artificial Heart, accounting for more than 250 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