Healthcare Industry News: CardioWest
News Release - January 3, 2008
Artificial Heart Returns to UtahI-Med is 12th U.S. Hospital to Begin Phase II of Certification Training
SALT LAKE CITY--(HSMN NewsFeed)--On Jan. 3, I-Med (Intermountain Medical Center, formerly LDS Hospital) will complete the second phase of certification training for the CardioWest™ temporary Total Artificial Heart (TAH-t), bringing the artificial heart one step closer to returning to Utah. The third and final phase will be the proctored first implant of the artificial heart.
“Utah's artificial heart program here at Intermountain Medical Center will be one of only a handful of centers across the country to discharge patients with a total artificial heart," explained surgeon Stephen Clayson, M.D.
In the first half of 2008, SynCardia plans to submit an application to the FDA for an IDE clinical study of a new driver system designed for use in both the hospital and for discharge. If the study is approved, it will be the first IDE clinical study of a discharge driver for the CardioWest artificial heart in the U.S.
“U.S. artificial heart patients are currently confined to the hospital while they wait for their donor hearts for transplant,” said Rodger Ford, CEO and president of TAH-t manufacturer SynCardia Systems, Inc. “Since 2006, stable TAH-t patients in Europe have been able to recover at home thanks to the CE approved portable driver. Today, there are three times more artificial hearts being implanted in Europe because of the portable driver: It improves the patients’ quality of life and virtually eliminates in-hospital costs while these patients wait for their donor hearts at home.”
In the 1990s, LDS Hospital was one of five hospitals to participate in the 10-year clinical study of the CardioWest artificial heart. In the study, 79 percent of patients receiving the TAH-t survived to transplant (New England Journal of Medicine 2004; 351: 859-867). This is the highest survival rate for any approved heart device in the world. The TAH-t also has the highest cardiac output of any approved device, pumping up to 9.5L/min.
The CardioWest artificial heart is the world’s first and only FDA, Health Canada and CE approved temporary artificial heart. Originally designed as a permanent replacement heart, it is currently approved as a bridge to human heart transplant for patients dying from end stage biventricular failure.
Source: SynCardia Systems
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