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UMC-designed heart given FDA OK

CHRIS CUDUTO/Arizona Daily Wildcat
Dr. Jack G. Copeland, UA professor of surgery and co-director of the Sarver Heart Center at the UA College of Medicine, holds the artificial heart that he helped create. The FDA approved the artificial heart yesterday.
By Kylee Dawson
Arizona Daily Wildcat
Tuesday, October 19, 2004
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The Food and Drug Administration approved the first temporary artificial heart, developed by a UA professor, yesterday.

Designed by Dr. Jack G. Copeland, a surgery professor, the CardioWest Total Artificial Heart is the first artificial organ to be approved by the FDA.

"It's a lifesaver," said Copeland, who is the co-director of the Sarver Heart Center at the UA College of Medicine. "It saves people's lives."

The biventricular implant, an air-driven device, is used in patients who suffer from heart failure and are waiting for a transplant.

"There's never been a total artificial heart approved and this is really the only device that you can call an artificial organ because it's not just a prosthesis, it really takes the place of the heart," Copeland said.

Copeland began work on the concept for the artificial heart 19 years ago. With a team from the University Medical Center, Copeland began developing the CardioWest Total Artificial Heart in 1991 and completed it in 1993.

After submitting a 5,000-page report - which included data, test results, survival rates and complications - to the FDA in 2002, Copeland said the FDA had to visit the plant where the artificial heart was made before they approved the heart.

"This has been a 40-year project which we finally completed," said Dr. Marvin J. Slepian, professor of medicine, director of interventional cardiology at UMC and CEO of SynCardia Systems Inc., the private company that owns the rights to the artificial heart.

"I think it's a major advance in medicine, a major advance for technology and ultimately it's a major advance for patients that have end stage heart failure," Slepian said.

The CardioWest Total Artificial Heart was supposed to be approved in September, but FDA paperwork took longer than UA doctors anticipated.

"You never know when you're working with the FDA," Copeland said. "It was nothing really very serious, but it took about three weeks (longer)."

The cost of the device and its components is $100,000, but Copeland said insurance companies should cover the cost now that it is FDA approved.

"It fills in a therapeutic gap that's existed and I think that what our challenge will be will be, to disseminate the information, teach people to use this device, let other centers have a chance to experience this technology," Copeland said, "and I'm convinced that once they do, they will be very happy with the results."

There are five million patients in the United States with congestive heart failure, Slepian said.

"This is a disease of epidemic proportions on the rise," he said. "The only real therapy for (some) patients is a heart transplant and in the United States, there's certain criteria to be eligible for a transplant."

Five hundred thousand patients are diagnosed with heart failure each year. Of those, 100,000 patients with the most severe type of heart failure, and only about 8,000 are eligible for an artificial heart transplant

To be eligible for a transplant, a patient must meet criteria such as being in the right age group and not having a secondary disease.

For this reason, "there was a tremendous need for a device which could act as a safety net to prevent the deaths of the patients," Slepian said. "That's what the artificial heart is for."

The first attempt to develop an artificial heart was during the John F. Kennedy presidency at the same time man first walked on the moon, Slepian said.

"Well, we got to the moon but we never completed the heart project and to finally see this completed is truly a milestone for American medical technology and for medicine in general," Slepian said.

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