In short
SynCardia Systems, Inc., manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, has won three awards including one at the beautifully named Copper Cactus Awards in Tucson, Arizona (where else?)
Background
SynCardia Systems, Inc. manufactures the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart, currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure.
There have been more than 1,000 implants of the Total Artificial Heart, accounting for more than 270 patient years of life.
Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers. It is the only device that provides immediate, safe blood flow of up to 9.5 litres per minute through each ventricle. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.
So it’s probably not that surprising to see the company winning the odd high profile award, nonetheless our congratulations for the Freedom® portable driver being voted best new product of the year at the Best in Biz awards. The Freedom portable driver is the world’s first wearable power supply for the temporary Total Artificial Heart and it allows stable patients who meet discharge criteria to wait for a matching donor heart at home and in their communities instead of in the hospital.
Finally the big one… the Copper Cactus Awards, announced Nov. 13, saw SynCardia honoured for exceptional innovation through technology for its Freedom portable driver.
Regulatory notes
The Freedom portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.
Source: SynCardia Systems, Inc.