Fast Company Magazine Names SynCardia #20 Among World's 50 Most Innovative Companies
SynCardia, Manufacturer of the World's Only Approved Total Artificial Heart, Honored Along with Apple, Twitter, Google and Intel http://www.syncardia.com
"Innovation has never been more important to our economy and our future," said Fast Company editor Robert Safian. "These companies embody what unleashing human potential can accomplish."
Fast Company selected SynCardia for "giving mobility to artificial heart recipients." Historically, U.S. Total Artificial Heart patients have been confined to the hospital while they wait for a matching donor heart because the only FDA-approved driver for powering the Total Artificial Heart weighs 418 lbs.
However, in 2010, SynCardia received FDA approval to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom® portable driver. Weighing 13.5 lbs, the Freedom driver is the first U.S. portable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is intended to allow stable Total Artificial Heart patients to be discharged from the hospital to wait for a matching donor heart at home and in their communities. So far, 22 Total Artificial Heart patients around the world have been supported by the Freedom driver, which is CE approved for use in Europe.
With more than 900 implants, SynCardia's Total Artificial Heart is 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 patients dying from end-stage heart failure of both ventricles (biventricular failure).
Fast Company's editorial team evaluated thousands of businesses across the globe to create the World's Most Innovative Companies issue, which is on newsstands beginning February 22, and available online at: www.fastcompany.com/MIC.
SynCardia Systems Inc
SynCardia Systems, Inc.is the Tucson-based manufacturer of the world's only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary Total Artificial Heart. There have been more than 900 implants of the Total Artificial Heart, accounting for more than 210 patient years of life on the device.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.