Press Release:

Dr. Stephen Clayson, LDS Hospital

TUCSON, Ariz. – July 17, 2007 – On July 17 and 18, cardiothoracic surgeon Dr. Stephen Clayson, M.D., and his heart transplant team from LDS Hospital in Utah, are in Tucson receiving the first phase of certification training to implant the CardioWest temporary Total Artificial Heart (TAH-t). 

In the 1990s, LDS Hospital was one of five participating hospitals active in the pivotal clinical study of the CardioWest TAH-t. On March 17, 2004, during a public meeting with the FDA panel reviewing the device, cardiothoracic surgeon James Long, M.D., spoke in support of the TAH-t. Dr. Long was the founder and has been the director of the Utah Artificial Heart Program at LDS Hospital since 1993.

On Oct. 15, 2004, the CardioWest TAH-t became the first and still only FDA approved temporary total artificial heart in the world.

The first phase of training is occurring at University Medical Center in Tucson. The remaining three phases of TAH-t certification training take place at the hospital being certified.

The third phase of certification is the proctored implant of the artificial heart by artificial heart pioneer Dr. Jack Copeland or another TAH-t veteran surgeon. LDS and all TAH-t certified hospitals have years, and often decades, of experience in human heart transplantation.

In the pivotal clinical study, the TAH-t had a bridge-to-transplant success rate of 79 percent (New England Journal of Medicine 2004; 351: 859-867), which is the highest success rate of any heart assist device in the world.

LDS Hospital, recognized as Utah’s premier healthcare facility in 2006 by the “Best of State” program, will join 21 of the world’s finest transplant hospitals in the U.S., Canada and Europe that are certified to implant the TAH-t.

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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