TUCSON, Ariz., June 20, 2012 /PRNewswire/ -- On June 18, SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, was honored with two Gold Stevie® Awards at the 10th Annual American Business Awards. SynCardia won “Company of the Year Health Products and Services” and “Most Innovative Company of the Year up to 100 Employees.”
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“We are honored to be recognized as an industry leader by the nation’s premier business awards program,” said Michael Garippa, SynCardia Chairman/CEO/President. “With donor hearts in short supply, the SynCardia temporary Total Artificial Heart powered by the Freedom® portable driver is rapidly becoming the new standard of care for end-stage biventricular (both ventricles) heart failure.”
On April 24, SynCardia completed the minimum enrollment required by its FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom portable driver, the world’s first wearable power supply for the Total Artificial Heart. Weighing 13.5 pounds, the Freedom portable driver is designed to allow stable Total Artificial Heart patients who meet discharge criteria to leave the hospital and resume their lives at home while they wait for a matching donor heart. The Freedom driver, which is also CE approved for use in Europe, has supported more than 85 patients worldwide, accounting for more than 30 patient years of support.
Nicknamed the Stevies for the Greek word for “crowned,” the trophies were presented to honorees during a gala banquet on Monday, June 18 at the Marriott Marquis Hotel in New York. More than 500 nominees and their guests attended. The presentations were broadcast live by the Business TalkRadio Network. More than 3,000 nominations from organizations of all sizes and in virtually every industry were submitted this year for consideration.
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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. (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 1,000 implants of the Total Artificial Heart, accounting for more than 250 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.
SOURCE SynCardia Systems, Inc.
