Press Release:
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
The SynCardia temporary Total Artificial Heart is similar to a heart transplant in that it replaces both the right and left heart ventricles.
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 50 Companies to Watch for 2010.
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).”
The Freedom™ portable driver with the SynCardia temporary Total Artificial Heart
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.
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About 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 850 implants of the Total Artificial Heart, accounting for more than 190 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.
For additional information, please visit: http://www.syncardia.com
or follow SynCardia on Twitter – @SynCardia_News
Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660
SynCardia temporary CardioWest™ Total Artificial Heart.
