Report: Kids' stent maker faces fed probe

NEW YORK, July 5 (UPI) -- A U.S. maker of coronary stents and catheters designed for use in children is facing a federal probe, the Wall Street Journal said Thursday.

According to the report, medical device maker NuMed and its chief Allen Tower are the target of an investigation by the Food and Drug Administration and federal prosecutors in Delaware, based on allegations that the company promoted unapproved stents for use in children.

WSJ reported that, according to the FDA, Tower sold more than 30 stents to the DuPont Hospital for Children in Wilmington, Del., but failed to file with the agency for approval each time a stent was sold, as required by FDA regulations.

The case highlights the quandary in which pediatric cardiologists find themselves because doctors say using the unapproved stents made by NuMed is safer than treating children with stents that are only approved by the FDA for use in adults.

If federal authorities move forward with the case, NuMed could be banned from selling the pediatric devices and children would have to go to Europe to receive treatment with the stents, where they can be used in emergencies, the report said. Tower also faces a multimillion dollar fine if found liable, the newspaper noted.

According to WSJ, nearly 600 cardiologists and parents worldwide have signed a petition saying any action against NuMed would mean "a devastating loss to patients."