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Press Release:

SynCardia Wins 2012 Medical Design Excellence Award

Freedom® Portable Driver for Powering SynCardia's Total Artificial Heart
Honored in Critical Care and Emergency Medicine Category

2012 Medical Design Excellence Awards Winner

TUCSON, Ariz. – May 31, 2012 – SynCardia Systems, Inc., the privately-held manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that the company's Freedom® portable driver, the world's first wearable power supply for the SynCardia temporary Total Artificial Heart, was selected as the Bronze Winner in the Critical Care and Emergency Medicine category of the 2012 Medical Design Excellence Awards (MDEA) on May 23 in Philadelphia.

Karen_Freedom_MDEASynCardia Product Manager Karen Stamm holds the SynCardia temporary Total Artificial Heart while wearing the Freedom® portable driver, the world's first wearable power supply for the Total Artificial Heart. For added patient comfort and convenience, the Freedom driver is designed to be worn in the Backpack or Shoulder Bag (not pictured).

"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 among "America's Most Promising Companies"
  • Fast Company Magazine ranking SynCardia #20 among the "World's 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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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, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end stage heart failure affecting both sides of the heart (biventricular failure). More than 400 SynCardia Total Artificial Heart implants have been performed since January 2011. The SynCardia Heart has provided almost 130,000 patient days of support from nearly 1,300 implants. The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 76 years old.

Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at 97 SynCardia Certified Centers worldwide with 39 others in the process of certification.

The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

For up-to-date 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

 

 

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

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