Pediatric stent-maker faces FDA investigation

A company that makes coronary stents and catheters for pediatric use is facing an investigation by the FDA and federal prosecutors, who contend that it promoted non-approved stents for use in children. They say device maker NuMed sold more than 30 stents to the DuPont Hospital for Children in Wilmington, Del., but didn't file for FDA approval prior to selling the stents as agency regs require. If the FDA investigation moves forward, NuMed ultimately could be banned from selling the devices in the United States, forcing children to go to Europe if they need this device. NuMed also would be forced to pay several million dollars in fines.

Alarmed by the FDA investigation, about 600 cardiologists and parents worldwide have begun circulating a petition asking the agency to drop the NuMed investigation. They say the NuMed products are safer than using adult stents on children, and that stopping their sale could harm young heart patients substantially.

To learn more about the investigation:
- read this United Press International piece
- and this Wall Street Journal report

Related Articles:
Insurers may cut stent payouts. Report
Decline in drug-coated stent use at top cardiac centers. Report
Stent study surprises clinicians. Report
Cardiologists stand by stents. Report