Press Release:

The modern 70cc CardioWest artificial heart (left) and the older 100cc Jarvik 7.

TUCSON, Ariz. – Dec. 12, 2007 – On Nov. 30 and Dec. 1, more than 200 surgeons, biomedical engineers and heart device executives gathered at the University of Utah to celebrate the first implant of the Jarvik 7 artificial heart on Dec. 1, 1982, and present the current state of artificial heart pumping technology.

“The artificial heart is the result of six decades of work by many of the giants in medicine. Over the last 25 years we have made major improvements in the areas of surgical technique, anticoagulation (blood management) and patient care protocols,” said Steve Langford, vice president of clinical support for SynCardia Systems, Inc.

Today, the modern version of the Jarvik 7, the CardioWest™ temporary Total Artificial Heart (TAH-t), is the first and only temporary artificial heart to receive FDA, Health Canada and CE approval.

“When all other treatments fail, the CardioWest artificial heart is able to save the sickest of the sick,” explained cardiothoracic surgeon Dr. Jack Copeland. “These patients are often days, if not hours from death. Their survival is dependent on receiving a donor heart, or a CardioWest artificial heart as a bridge to human heart transplant.””

In the pivotal clinical study of the TAH-t published in the New England Journal of Medicine (NEJM 2004; 351: 859-867), 79 percent of patients receiving the TAH-t survived to transplant. This is the highest survival rate for any device in the world.

In the 1990s, the Jarvik 7 technology was transferred to University Medical Center (UMC) in Tucson, Ariz., where it was renamed the CardioWest. Originally designed as a permanent replacement heart, UMC surgeon Dr. Copeland was the first surgeon to successfully use the artificial heart as a bridge-to-transplant in 1985.

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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