Press Release:

The SynCardia temporary Total Artificial Heart is similar to a heart transplant in that it replaces both the right and left heart ventricles.

TUCSON, Ariz. – June 17, 2010 – Medical Device and Diagnostic Industry (MD+DI) magazine has selected SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, as one of 50 Companies to Watch for 2010.

MD+DI’s Reason to Watch: “The SynCardia Total Artificial Heart is the only device of its kind with regulatory approval in the United States, Canada, and Europe. The device, meant for people dying from end-stage biventricular failure, works similar to a heart transplant in that it replaces both the right and left heart ventricles. Plus, there’s no waiting list like there is for donor hearts (the company has certified centers set up throughout the world).”

The Freedom™ portable driver with the SynCardia temporary Total Artificial Heart

SynCardia recently received conditional approval from the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the 13.5 lb Freedom® driver, the first ever U.S. portable driver designed to power SynCardia’s Total Artificial Heart both inside and outside the hospital. The first U.S. patient was discharged from the hospital on May 3. In Europe, where the Freedom driver has CE approval, two patients have been discharged home, one in Nantes, France and one in Moscow, Russia.

SynCardia is the only company with an approved mechanical circulatory support (MCS) device to make the list. MCS devices include left ventricular assist devices (LVADs), biventricular assist devices (BiVADs) and SynCardia’s Total Artificial Heart.

MD+DI solicited nominations from readers, its Editorial Advisory Board and Reader Board, and industry observers, and analyzed nominee information before producing the list.

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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