FDA Classifies Medtronic's Physician Communication Related to Inflammatory Mass Formation...

FDA Classifies Medtronic's Physician Communication Related to Inflammatory Mass Formation from Intrathecal Drug Therapy

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(R) and IsoMed(R) 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(R) is a registered trademark of Baxter Healthcare
Corp

Medtronic, Inc.
Jeff Warren, 763-505-2696
Investor Relations
or
Cindy Resman, 763-505-0291
Public Relations

Copyright Business Wire 2008