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Giant Step for 'Commercialization' of Artificial Heart Developed in Arizona

Posted on: Wednesday, 3 August 2005, 21:00 CDT

Aug. 3--The CardioWest artificial heart, developed at University Medical Center, has been put to its first commercial use in the United States.

The renowned Cleveland Clinic implanted a Cardio-West Temporary Total Artificial Heart about a week ago in a dying man in his 40s.

"He's doing much better now," said Dr. Marvin Slepian, a University of Arizona cardiologist and president and CEO of SynCardia Systems Inc., the privately held company started in 2001 to manufacture and market the device.

The Cleveland Clinic is the first "new" U.S. hospital to use the CardioWest outside of UMC and other hospitals that were involved in the research leading up the device's approval by the Food and Drug Administration last year.

UMC and hospitals in Europe have implanted more than 30 CardioWest hearts in dying patients since the FDA's October 2004 decision to allow the device to be used at qualified centers throughout the United States.

"This represents the kickoff of the American commercialization of this technology," Slepian said Monday.

The FDA has given earlier approval to a few devices that take over pumping for one or both of the heart's ventricles, the two pumping chambers of the heart.

The CardioWest is the first FDA-approved total artificial heart. It is used in patients who face imminent death when both of their ventricles stop working.

The listed retail price for the heart is $100,000 in the United States, Slepian said.

It is not simply a matter of a heart surgeon calling up SynCardia and ordering one of the artificial heart pumps. SynCardia is required by the FDA to train a center -- its surgeons, cardiologists, technicians, operating room staff, nurses and other personnel involved in cardiac critical care -- before they can use the device on a patient.

"It's more of a center opening," Slepian said. "They have to go through a rigorous training program -- didactic and hands-on, first with a cadaver or pig, then ultimately on a human patient. Each session is several days, but logistically it takes two to three months to train a center." Efforts to reach Cleveland Clinic doctors on Monday afternoon were not successful.

"Multiple other centers" have requested training to begin using the CardioWest, Slepian said.

The CardioWest is a revised version of the first artificial heart ever used, in December 1982. The Jarvik-7 heart kept Barney Clark of Seattle alive at the University of Utah for 112 days.

Dr. Robert Jarvik began collaborating with Dr. Jack Copeland, head of UMC's artificial-heart and heart-and-lung transplant programs, in 1985. That year, Copeland became the first surgeon in the world to use an artificial heart as a bridge to transplant with a human donor heart.

Copeland and UMC took over what was then called the Symbion Heart in 1991. UMC invested about $10 million in the device to keep it available to patients on a research basis prior to SynCardia's start four years ago.

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Copyright (c) 2005, The Arizona Daily Star, Tucson

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Source: The Arizona Daily Star

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