According to Ziyad Hijazi, chief of pediatric cardiology at Rush University Medical Center, and other doctors, children receive worse treatment in the United States, and have even died, because pediatric medical devices are not approved. Hijazi travels annually with two or three children ad their families to Jordon for heart operations where medical devices not approved for use in the United States are available.
Hijazi implanted an amplatzer muscular VSD to close a hole between the lower chambers of the heart in a child from Massachusetts. The device was manufactured by Minneapolis-based AGA Medical and was available for nine years in Jordan before finally being approved in the US in 2007. Hijazi said over 90 percent of the medical devices he uses on children are “off-label”–approved by the U.S. Food and Drug Administration (FDA) for other uses, such as adult use. “We take responsibility as physicians for using unapproved devices on kids,” he said.
In the years 1989-2000, only one stent—a device that props open heart vessel walls—was appropriate for pediatric use, said Thomas Forbes, director of cardiac catheterization at Children’s Hospital of Michigan in Detroit. “In the ’90s, we lost lives in the cath lab. Patients have died on the table because we were using stents that were made for adults and weren’t flexible enough,” Forbes said. Having to use adult-sized devices on children can be the difference between “potentially dangerous care and very good care,” he said. Three stents can be modified for pediatric use; none are approved for such use in the US, Forbes said. Other pediatric specialists voice similar complaints, saying they either use devices approved for adults or hand-make their own.
Companies often focus on adult-sized devices because the market is bigger. Also, heart diseases in children, are likelier to be congenital and rare; in adults they are more likely to be progressive, and common.
Meanwhile, a law signed late last year provides financial incentives to companies for making devices for children; however, those companies must also track patients at their own expense. “It’s a paperwork nightmare. They have to commit resources and follow these patients forever,” Forbes said. There are other issues and some solutions, for instance a significant tax credit for research and development in this area, but that is not being discussed, Federici said. Richard Ringel, a pediatric cardiologist at Johns Hopkins Hospital, said he is awaiting the next innovation in cardiovascular medicine: Stents that dissolve inside the body “… do you think Johnson & Johnson is going to be interested in doing this for babies? No, they want to do it for (adult) coronary patients because the numbers are so much larger,” Ringel said.
“Development (of pediatric devices) is time-consuming, there are regulatory hurdles, and how do you recoup your investment? The math generally does not work,” said Edwards Chairman and Chief Executive Michael Mussallem, who is president of AdvaMed, who added that it comes down to economics and physicians are just used to getting by with what they have.
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