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2012 Medical Design Excellence Award Winner

Toronto News, (PR) August 4, 2012

SynCardia Systems, Inc., the privately-held manufacturer of the worlds first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced that the company’s Freedom portable driver, the worlds first wearable power supply for the SynCardia temporary Total Artificial Heart, has been selected as the Bronze Winner in the Critical Care and Emergency Medicine category of the 2012 Medical Design Excellence Awards (MDEA).

SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the worlds first and only FDA, Health Canada and CE approved Total Artificial Heart, originally used as a permanent replacement heart.

It is an honor to have the premier competition for medical device design and innovation recognize the achievements of our Freedom portable driver, said Michael Garippa, SynCardia Chairman/CEO/President. For the first time in U.S. history, the Freedom portable driver is allowing stable patients without human hearts to leave the hospital and resume their lives at home while they wait for a matching donor heart. The Freedom driver is pivotal in the Total Artificial Heart becoming the new standard of care for end-stage biventricular heart failure.

Weighing 13.5 pounds, the Freedom portable driver is designed to be worn by the patient in the Freedom Backpack or Shoulder Bag. 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. More than 80 patients worldwide have been supported by the Freedom driver, accounting for more than 30 patient years of support.

MDEA entries were evaluated on the basis of their design and engineering features, including innovative use of materials, user-related functions that improve healthcare delivery and change traditional medical attitudes or practices, features that provide enhanced benefits to the patient, and the ability to overcome design and engineering challenges to meet clinical objectives.

SynCardia would like to recognize and thank the dedicated vendors who played crucial roles in the design, development and manufacture of the Freedom portable driver: Bimba Manufacturing (University Park, IL), Origin Product Development (Maynard, MA), Lynium LLC. (Tucson, AZ), Yarbrough Electronic Sales (Tucson, AZ), Applimotion Inc. (Loomis, CA), and CGI Inc. (Carson City, NV).

Other recent SynCardia awards and achievements include:

The MEDTEC European Medical Device Technology (EMDT) Innovation Awards naming the Freedom driver a finalist for “Most Innovative Cardiac Product of the Year
Forbes Magazine ranking SynCardia amongAmerica’s Most Promising Companies
Fast Company Magazine ranking SynCardia #20 among the Worlds 50 Most Innovative Companies

CAUTION The Freedom portable driver is an investigational device, limited by United States law to investigational use.


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