SynCardia Named Among Top 50 Companies to Watch by Medical Device and Diagnostic Industry Magazine
Total Artificial Heart Manufacturer Only Company to Make the List with an FDA-Approved Mechanical Circulatory Support Device
50 Companies to Watch for 2010.TUCSON, Ariz. – June 17, 2010 – Medical Device and Diagnostic Industry (MD+DI) magazine has selected SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, as one of
MD+DI’s Reason to Watch: “The SynCardia Total Artificial Heart is the only device of its kind with regulatory approval in the United States, Canada, and Europe. The device, meant for people dying from end-stage biventricular failure, works similar to a heart transplant in that it replaces both the right and left heart ventricles. Plus, there’s no waiting list like there is for donor hearts (the company has certified centers set up throughout the world).”
SynCardia recently received conditional approval from the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the 13.5 lb Freedom® driver, the first ever U.S. portable driver designed to power SynCardia’s Total Artificial Heart both inside and outside the hospital. The first U.S. patient was discharged from the hospital on May 3. In Europe, where the Freedom driver has CE approval, two patients have been discharged home, one in Nantes, France and one in Moscow, Russia.
SynCardia is the only company with an approved mechanical circulatory support (MCS) device to make the list. MCS devices include left ventricular assist devices (LVADs), biventricular assist devices (BiVADs) and SynCardia’s Total Artificial Heart.
MD+DI solicited nominations from readers, its Editorial Advisory Board and Reader Board, and industry observers, and analyzed nominee information before producing the list.
About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.
Janelle Drumwright, firstname.lastname@example.org, (520) 547-7463