Press Release:

CardioWest™ Double Header Training at UMC

TUCSON, Ariz. – April 18, 2006 – On Thursday and Friday, April 20 and 21, cardiovascular surgeon Benjamin Sun, M.D. of Ohio State University Ross Heart Hospital, and the 13 members of his transplant team will be at University Medical Center (UMC), in Tucson, to complete Phase I of the CardioWest™ TAH-t certification training. On that following Monday and Tuesday, Dr. Michael A. Acker, chief of the division of cardiothoracic surgery at the University of Pennsylvania Health System, and 7 members of his surgical team will also complete Phase I training.

According to the “U.S. News and World Report 2005 Best Heart Hospitals” list, The University of Pennsylvania Health System is ranked 20th best hospital for heart care and Ohio State University Ross Heart Hospital, is ranked 39th.

The TAH-t is the only FDA, Health Canada and CE approved Artificial Heart in the world. The Artificial Heart is a bridge to transplant for patients with end-stage biventricular heart failure who are waiting for a donor human heart.

End-stage biventricular failure is a condition in which a weakened heart slowly loses its ability to pump blood through the body efficiently. The superior blood pumping ability of the TAH-t, up to 9.5 liters per minute, helps to rejuvenate vital organs that have atrophied because of a failing heart.

A New England Journal of Medicine paper published in Aug. 2004, states that, in the pivotal clinical study of the TAH-t, the one year survival rate for patients receiving the CardioWest temporary Total Artificial Heart was 70 percent versus 31 percent for control patients who did not receive the device.

Phases two and three of the CardioWest TAH-t training program are conducted at the hospital being certified. The second phase is devoted to ensuring that the hospital and its transplant team are “implant ready”.

The third phase involves proctored surgical training by Dr. Copeland or another TAH-t veteran surgeon. The surgeon travels to the hospital being certified to monitor the first TAH-t implant. All TAH-t certified hospitals have years, and often decades, of experience in human heart transplantation.

The TAH-t is a modern version of the Jarvik-7 Artificial Heart that was implanted in Barney Clark in 1982. In the 1990s the device and technology moved to University Medical Center (UMC) in Tucson and was subsequently renamed the CardioWest™ temporary Total Artificial Heart. Budget cutbacks at UMC came close to stopping the study of this technology. To save the TAH-t, SynCardia Systems, Inc. was formed in 2001 by Marvin J. Slepian, M.D., Richard G. Smith, MSEE, CCE, and surgeon Jack Copeland, M.D. All three men, along with other medical professionals, are instructors for the TAH-t certification training program.

On January 20, 2006, during its annual share holders meeting, SynCardia projected that TAH-t certified implant centers will increase from 9 to 28 hospitals world wide this year. According to SynCardia’s President and CEO, Rodger Ford, “This growth will convert the company from a scientific venture into a profitable life-saving business.”


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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 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.

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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