TUCSON, Ariz., Dec. 8, 2011 /PRNewswire/ -- SynCardia Systems, Inc. (www.syncardia.com), the privately-held manufacturer of the world's only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, has been selected by Forbes as one of "America's Most Promising Companies." The list features 100 privately held up-and-comers with compelling business models, strong management teams, notable customers, strategic partners and precious investment capital. Ranked No. 77, SynCardia was the only Arizona company to make the cut.
"In 2010, SynCardia doubled sales over 2009, and in 2011, we are on track to double sales again, representing a four-fold increase since 2009. We are profitable for the first time in the company's 10-year history," said Michael Garippa, CEO/President. "SynCardia is lean by design and many of our employees are cross-trained in multiple departments. Every Friday, we continue our six-year tradition of the entire company having lunch together and sharing project updates to ensure everyone is on the same page."
SynCardia designed, developed, and launched the Freedom® portable driver, the world's first wearable power supply for the SynCardia temporary Total Artificial Heart. Weighing 13.5 pounds, 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. To date, 34 patients have been enrolled in the study. Of these patients, 23 have been discharged from the hospital using the Freedom driver. The study requires that 30 patients be discharged.
Worldwide, more than 65 patients have been supported by the Freedom portable driver. From Russia to Richmond, from Australia to Arizona, Total Artificial Heart patients have been discharged from the hospital without human hearts to wait for a matching donor heart at home and in their communities. There are currently SynCardia Certified Centers in 12 countries on 3 continents – North America, Europe and Australia.
Prior to the development of the Freedom driver, stable Total Artificial Heart patients in the U.S. were confined to the hospital for months, sometimes years while they waited for a matching donor heart because the only FDA-approved driver is hospital-based "Big Blue" which weighs 418 pounds.
SynCardia has been honored with multiple awards in 2011, including being ranked #20 in Fast Company's annual list of the "World's 50 Most Innovative Companies," named "Arizona Bioscience Company of the Year" and selected as one of six finalists for the World Technology Award in Health and Medicine by the World Technology Network in association with TIME, Fortune, CNN, Science/AAAS and Technology Review.
CAUTION – The Freedom® portable driver is an investigational device, limited by United States law to investigational use.
About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. manufactures the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, the Total is currently approved as a bridge to transplant for people dying from end-stage heart failure affecting both sides of the heart (biventricular failure). More than 950 implants account 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. It is the only device that eliminates the symptoms and source of end-stage biventricular heart failure and pumps 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.
Fast Company ranked SynCardia#20 among the World's 50 Most Innovative Companies "for giving mobility to artificial heart recipients."
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|SOURCE SynCardia Systems, Inc.|
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