These awards are regarded as a universal benchmark of quality within the medical-device industry. The Freedom portable driver has been pivotal in the Total Artificial Heart becoming the new standard of care for end-stage biventricular heart failure.
Tucson, Ariz. (PRWEB) January 26, 2012
SynCardia Systems, Inc., manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that it has been nominated for one of the most prestigious awards in the European medical device industry.
The Freedom® portable driver, the world’s first wearable power supply for the SynCardia temporary Total Artificial Heart, has been shortlisted for “Most Innovative Cardiac Product of the Year” as part of the MEDTEC European Medical Device Technology (EMDT) Innovation Awards. The Awards are the only European awards dedicated to recognizing achievements in the medical device sector.
“These awards are regarded as a universal benchmark of quality within the medical-device industry,” said Michael Garippa, SynCardia CEO/President. “Being shortlisted is a tremendous achievement. The Freedom portable driver has been pivotal in the Total Artificial Heart becoming the new standard of care for end-stage biventricular heart failure.”
Weighing approximately 6 kg (13.5 lbs), the Freedom portable driver allows stable Total Artificial Heart patients to be discharged from the hospital to enjoy life at home while they wait for a matching donor heart. 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 70 patients worldwide have been supported by the Freedom driver, accounting for more than 24 years of patient support.
This year’s winners will be announced on March 14, 2012, at a special ceremony during MEDTEC Europe 2012, in the Atrium of the Messe Stuttgart in Stuttgart, Germany.
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.