CHICAGO (Reuters) -
Every year, Chicago-based cardiologist
Ziyad Hijazi accompanies two or three children and their
families to his native Jordan for heart operations using
medical devices that are not approved in the United States.

In one such case, Hijazi implanted a device to close a hole
between the lower chambers of the heart in a child from
Massachusetts. The device, called an amplatzer muscular VSD,
manufactured by Minneapolis-based AGA Medical, was available
for 9 years in Jordan before it was approved in the United
States in 2007.

According to Hijazi, who is chief of pediatric cardiology
at Rush University Medical Center, and other doctors, children
are getting worse treatment in the United States, and have even
died, because pediatric medical devices are not approved.

Hijazi said that more than 90 percent of the medical
devices he uses on children are “off-label,” meaning that they
are approved by the U.S. Food and Drug Administration for other
uses, for example for use in adults.

“We take responsibility as physicians for using unapproved
devices on kids,” he said.

From 1989 to 2000, only one stent — a tubular device that
props open vessel walls — was appropriate to use in children,
said Thomas Forbes, director of cardiac catheterization at
Children's Hospital of Michigan in Detroit.

Stents are delivered through catheters, usually entering
the body through the large vessel in the groin, and then
threaded through the body to the destination.

“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.

Making do with adult-sized devices rather than using ones
designed for children can be the difference between
“potentially dangerous care and very good care,” he said.

There are currently three stents that can be modified for
pediatric use, but none of them is approved for use in children
in the United States, Forbes said.

While much of the focus is on cardiology, pediatric doctors
from other specialties, like orthopedics, echo these concerns,
saying they either use devices approved for adults or hand-make
their own devices.

One factor is that companies that make medical devices
focus on adults because the market is bigger. Heart diseases in
children, for example, are more likely to be congenital, and
rare, while in adults they are more likely to be progressive,
and common.

A law signed late last year provides financial incentives
to companies for making devices for children, but also requires
those companies to track patients at their own expense.

“It's a paperwork nightmare. They have to commit resources
and follow these patients forever,” Forbes said. “If I'm a J&J
stockholder, I'm saying, 'I love kids, I'd love to help them
out, but move on.”'

Tara Federici of AdvaMed, the trade association
representing medical device makers, said the industry is
looking to a meeting sponsored by the National Institutes of
Health in Washington on July 23 for guidance.

“First, we need to understand what the needs are and I'm
hopeful that NIH will help catalogue the needs,” said Federici,
who noted that part of the problem was that physicians do not
communicate effectively with industry.

Beyond that, financial, ethical and regulatory hurdles
abound.

One solution might be if the government offered 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

“We're all anxious for the dissolvable stent…but 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.

Privately held NuMed Inc has filled some of the gaps in
pediatric cardiovascular medicine, but the company is small and
limited in its resources.

Edwards Lifesciences, the world's biggest maker of heart
valves, is one example of a public company that has developed a
product for children — a blood-oxygen monitor — but the
company acknowledges the limitations.

“We have not cracked the code on this,” said Edwards
Chairman and Chief Executive Michael Mussallem, who is
president of AdvaMed.

“Development (of pediatric devices) is time-consuming,
there are regulatory hurdles and how do you recoup your
investment? The math generally does not work,” he said.

Sales of Edwards' first pediatric device generated sales of
just a couple million since its launch last year. The company
said the potential of the market is $30 million to $35 million,
a fifth to a quarter of the adult market.

Moreover, ethical issues associated with conducting
clinical trials on children and legal liability are two other
big obstacles, Mussallem said.

'NOT A CLIMATE FOR INNOVATION'

“There's not a climate for innovation. A great percentage
of devices are used off-label to accommodate children's needs.
Physicians are just used to getting by. It all comes back to
the economics.” Mussallem said. “There is a hole there and I
don't know how to bridge it. We need public or private
funding.”

Bram Zuckerman, Director of the Division of Cardiovascular
Devices at the U.S. Food and Drug Administration, which
regulates and approves medical devices, said part of the
challenge is to get physicians to communicate better with both
industry and regulators.

“The agency is very sensitive right now to the need to
foster and develop pediatric devices and we're looking to
develop many different pathways,” Zuckerman said.

He said FDA will be more flexible in the way it evaluates
data on devices.

For example, he said FDA recognizes that randomized
controlled clinical trials — the gold standard in which
participants receive the device while others receive standard
treatment — are not always possible.

“That doesn't mean we want to skimp on other key features
of clinical trial designs,” he said.

Daniel Schultz, director of FDA's Center for Devices and
Radiological Health, added, “Our frustrations are the same as
everyone else's. We'd like to work with companies, but we don't
have the kinds of comprehensive studies that we'd like. No one
has ever done a broad study of gaps and needs and that would be
really helpful to direct our efforts.

“Surgeons tend to be inventive in terms of being able to
adapt things that may not be perfect. I think we all recognize
that it would be better if we had devices developed for
specific situations,” said Schultz.

(Reporting by Debra Sherman; Editing by Eddie Evans)