Children treated abroad as U.S. doctors push for devices

By Debra Sherman

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.  Continued...