Investigation Could Limit Pediatric Coronary Stent Use
FDA and federal prosecutors in Delaware are investigating pediatric device company NuMed and its President and CEO Allen Tower on charges that the company marketed unapproved stents for use in children, which could result in a multimillion dollar fine and limitations on sale of the devices, the Wall Street Journal reports. NuMed manufactures custom-made catheters, therapeutic balloons and stents for children.
FDA found that Tower delivered more than 30 stents to two doctors at the DuPont Hospital for Children in Wilmington, Del., and concluded that the hospital was using the devices too often for them to be considered "custom devices," approved for use in emergencies. FDA told Tower he needed to file with the agency for specific approval each time he sold a device, which Tower admits he might not have done.
According to the Journal, the case against Tower "offers a window into a crucial dilemma involving pediatric heart devices."
While FDA is not questioning the safety of NuMed's devices, physicians worry that the pediatric devices "could become even harder to get" if Tower is prosecuted successfully, the Journal reports.
Physicians say that treating infants and children with devices that are approved for use in adults is less safe than using the unapproved devices manufactured by NuMed and that without companies such as NuMed, children will need to go to Europe to receive pediatric cardiac devices. The devices are approved in Europe for emergency uses.
More than 580 cardiologists and parents from around the world have signed a petition that says any action against NuMed could result in "a devastating loss to patients ... should Mr. Tower be relieved of his freedom or ability to continue his work."
Larry Latson, director of the congenital cardiac catheterization lab at the Cleveland Clinic, said, "The FDA wants more data" to approve pediatric devices "yet there are few patients to acquire the data," adding, "FDA's system does not work well for fields like ours, where there are small numbers of widely varying patients" (Burton/Banjo, Wall Street Journal, 7/5).