Healthcare Industry News: SynCardia Systems
News Release - March 10, 2008
Rush University Medical Center Begins Certification Training For CardioWest Temporary Total Artificial Heart
TUCSON, Ariz.--(HSMN NewsFeed)--On March 10 and 11, Rush University Medical Center’s mechanical circulatory support and heart transplant team led by Chair of Cardiovascular Thoracic Surgery, Robert S.D. Higgins, M.D. and Cardiologist Jose C. Mendez, M.D., will participate in the first phase of certification training for the CardioWest™ temporary Total Artificial Heart (TAH-t).“We are extremely excited about bringing this life-saving technology to the Chicagoland area for patients battling end stage heart failure. The CardioWest artificial heart provides the best biventricular support available,” Dr. Higgins said. If the IDE clinical study is approved by the FDA for the Companion Universal Driver, “we will be one of the first centers in the U.S. able to discharge artificial heart patients home for their recovery.”
In the first half of 2008, SynCardia Systems, Inc. plans to make an application to the FDA to conduct an IDE clinical study of a universal driver system designed for use in both the hospital and for discharge.
The third phase of CardioWest certification training is the proctored first implant of the artificial heart. Rush will be the 32nd hospital in the world and the 16th in the U.S. to complete the first phase of certification training. There are currently 24 TAH-t certified centers worldwide, with eight additional hospitals currently undergoing the certification process.
Rush University Medical Center was ranked among the best hospitals in 11 of 16 categories, including Heart and Heart Surgery, in the 2007 “America’s Best Hospitals” issue of U.S. News & World Report magazine. Founded nearly 170 years ago, Rush is also home to one of the first medical colleges in the Midwest and one of the nation’s top-ranked Magnet status nursing colleges, as well as graduate programs in allied health, health systems management and biomedical research.
Originally designed as a permanent replacement heart, the CardioWest artificial heart is currently approved as a bridge to human heart transplant for patients dying from end stage biventricular failure. These patients are often days, if not hours from death. Their survival depends on receiving a matching donor heart, or a CardioWest artificial heart as a bridge to transplant.
In the 10-year pivotal clinical study of the CardioWest artificial heart (New England Journal of Medicine 2004; 351: 859-867), 79 percent of patients receiving the TAH-t survived to transplant. This is the highest bridge to transplant rate for any heart device in the world.
Source: SynCardia Systems
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