Energia i regulacje · 27.06.1996

IsoStent, Inc., Receipt of a Petition for Rulemaking

The Nuclear Regulatory Commission (NRC) has received and requests public comment on a petition for rulemaking filed by IsoStent, Inc. The petition has been docketed by the Commission and assigned Docket No. PRM-35-14. The petitioner requests that the NRC amend its regulations by adding a new section to address permanently implanted intraluminal stents, including phosphorus-32 and strontium-89 radioisotope stents. These stents would be permanently implanted in the patient's vessels and arteries. The petitioner also requests that the NRC add a new section to specify training and experience requirements for qualified physicians responsible for placing radioisotope stents in patients. The petitioner believes the suggested amendments would address an innovative approach for the treatment of stenotic arteries and vessels with low-activity, beta-emitting stents.