MINNEAPOLIS - (Business Wire) Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) has classified its communication to physicians related to inflammatory mass formation associated with intrathecal drug delivery as a Class I Recall. 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. This letter was an update to two previous communications on this topic that Medtronic issued in 2001 and 2003. 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. Inflammatory mass is a chronic inflammatory or granulomatous mass at or near the tip of intrathecal catheters and has been reported with the infusion of morphine, baclofen and other physician-prescribed drugs and/or mixtures, including pharmacy-compounded drugs. Medtronic has noted an increase in reported cases of inflammatory mass associated with intrathecal drug delivery from 0.1 percent reported to date in 2001 to 0.5 percent reported to date in 2007. The actual incidence is likely to be higher than stated due to under-reporting, but the extent of under-reporting is currently unknown. To date, there have been no reported deaths associated with this issue.
The most frequently reported symptoms of inflammatory mass are decreased therapeutic response, pain, and neurological deficit/dysfunction. Serious reported symptoms include paralysis and other neurological impairments.
Inflammatory mass has been associated with a wide range of doses and concentrations of opioids. No dose and/or concentration of morphine sulfate can be considered free of risk from inflammatory mass. The risk of inflammatory mass occurrence appears to increase over time and with higher concentrations of opioids. Therefore, intrathecal opioids should be administered at the lowest effective dose and concentration.
Medtronic’s January 2008 physician letter provided physicians with specific patient management recommendations that include utilizing the lowest effective dose and concentration of opioids and patient monitoring for early clinical symptoms of inflammatory mass. The letter also recommends diagnostic steps for physicians to consider for patients who have new neurological symptoms aimed at preventing more severe outcomes.
This letter, which includes additional patient management information, is available through Medtronic’s website at www.medtronic.com/im.
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(a) (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.
“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,” said Richard E. Kuntz, M.D., senior vice president and president of the Neuromodulation business at Medtronic.
Medtronic’s intrathecal drug delivery systems consist of an implantable pump and catheter that deliver small quantities of drug directly into the intrathecal space in the spine. These devices are used to treat chronic, intractable pain and for the management of severe spasticity of cerebral or spinal origin.
Patients with questions should talk to their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday – Friday, 8 a.m. to 5 p.m. CDT (peer-to-peer physician consultation can be coordinated).
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.
(a) Infumorph® is a registered trademark of Baxter Healthcare Corp
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