Press Release:

Journal of Heart and Lung Transplantation Publishes Study
on SynCardia’s CardioWest™ temporary Total Artificial Heart

TUCSON, Ariz. – Aug. 14, 2004 – SynCardia Systems, Inc., a privately held developer of biomechanical cardiac replacement and assist devices, today announced that a single center nine year heart study has been published in the July 2004 edition of the Journal of Heart and Lung Transplantation. The study was conducted between January 1, 1993 and April 1, 2002 and followed 62 patients who received the CardioWest™ temporary Total Artificial Heart (TAH-t) after failing other medical therapies. All 62 patients were critically ill with biventricular heart failure and judged to be dying with almost no chance of survival to transplantation. The study found that after a mean support time of 92 days, 77% of TAH patients survived to transplant, with 88% of those surviving to hospital discharge.

“This study underscores the viability and value of the CardioWest™ temporary Total Artificial Heart for critically ill heart failure patients awaiting a heart transplant,” said Dr. Marvin J. Slepian, president and CEO, SynCardia. “This is an exciting time for the company and for the public as we expect imminent approval from the FDA for this life-saving device.”


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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 950 implants of the Total Artificial Heart, accounting 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, 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.

For additional information, please visit: http://www.syncardia.com
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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660

 

 

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

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