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
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.
"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.
SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart for use as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,350 implants of the SynCardia Total Artificial Heart account for over 400 patient years of life on the device. Since January 2010 more than 550 SynCardia Hearts have been implanted.
The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 76 years old. The longest a patient has lived with a SynCardia Heart was nearly four years (1,374 days) before receiving a successful donor heart transplant Sept. 11, 2011.
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged the hospital to live at home and in their communities. The wearable Freedom driver has been used by more than 200 patients, accounting for over 120 years of support