FDA classifies Medtronic’s intrathecal drug therapy

On January 16, 2008, Medtronic sent a letter to inform clinicians worldwide of an increase in the rate of reported inflammatory mass cases in patients who have received intrathecal drug delivery through its implantable infusion systems. The classification from the FDA does not change the recommendations made to physicians in the January 2008 letter and there is no new action required of physicians or patients.

Inflammatory masses have been reported in patients who receive intrathecal therapy through the SynchroMed and IsoMed infusion systems. Medtronic has noted an increase in reported cases of inflammatory mass associated with intrathecal drug delivery from 0.1% reported to date in 2001 to 0.5% reported to date in 2007.

The risk of inflammatory mass formation has been included in the labeling for Medtronic’s implantable drug infusion systems as either a warning or precaution, since 2001 and in the prescribing information for Infumorph (preservative-free morphine sulfate for microinfusion pumps) since 2003. Medtronic also recently received FDA approval for an update to the device labeling to include these new data.

Richard Kuntz, senior vice president and president of the Neuromodulation business at Medtronic, said: “Patient safety is our highest priority. Our communication to physicians reflects the importance we place on tracking product performance and reporting information that is useful to our customers in providing appropriate patient care.”