By ASHLEY DICKSON
A panel of advisers to the Food and Drug Administration voted 10-1 last week to support the approval of the use of a temporary artificial heart in transplant centers nationwide.
The CardioWest Total Artificial Heart, made by SynCardia Systems Inc., has been tested at five centers across the United States, including LDS Hospital in Salt Lake City and University Medical Center in Tucson, Ariz.
The Total Artificial Heart is an improved version of the first artificial heart, which was implanted in Barney Clark in 1982 at the University of Utah. Clark, a Provo native and pioneer in artificial heart surgery, lived on the heart for 112 days.
The panel, composed of experts in the field of cardiac surgery, recommended the Total Artificial Heart be used as a temporary bridge to cardiac transplantation. This artificial heart is on schedule to become the first to be approved and licensed by the federal government.
Steven Langford, general manager at SynCardia, said the full FDA approval won’t happen for another few months.
“We have been submitting information to the FDA over the past year and a half,” Langford said. “They ask us questions, we respond to them, and when they feel satisfied that they’ve received all the answers they convene this panel of experts in the field — that’s what happened last week.”
From that information, the FDA will prepare for the official authorization to commercialize the product, Langford said.
When the product has been approved for commercialization, nearly 200 hospitals across the nation with cardiac transplantation capabilities will begin putting the product into use. The FDA is not obligated to follow the panel’s advice, but usually does.
According to an Associated Press article, the Total Artificial Heart is a complex and risky device that requires cutting out the bottom half of the heart to implant and may cause side effects like infection, bleeding and stroke. Patients then wait until a donor heart becomes available.
During experiments over the past 10 years, the CardioWest heart has saved more than 200 patients in the United States and Europe. Pila Martinez, public affairs coordinator for the University of Arizona Sarver Heart Center, said 80 percent of patients who used the Total Artificial Heart have survived to get heart transplants.
“It’s a bridge to transplants — to keep them going until a suitable donor is found,” Martinez said. “It’s a very useful tool in prolonging people’s lives who need heart transplants.”
Rich Smith, chief operating officer of SynCardia, said the device has many possibilities in its future of helping patients.
“There are no other devices that do what this does,” Smith said. “If you put this in a surgeon’s toolbox, he has more capability to help patients than he did prior to this.”
