Remote Monitoring of Pacemaker Patients on Medtronic Carelink(R) Network Detects...

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Thu May 15, 2008 12:45pm EDT

Remote Monitoring of Pacemaker Patients on Medtronic Carelink(R) Network Detects Clinically Actionable Events More Quickly Than Combination of Transtelephonic Monitoring and Routine Office Visits

      Data Presented at Heart Rhythm Late Breaking Clinical Trial
MINNEAPOLIS & SAN FRANCISCO--(Business Wire)--
Data presented today at Heart Rhythm 2008, the annual congress of
the Heart Rhythm Society, shows that remote monitoring of pacemaker
patients via the Medtronic CareLink(R) Network detected clinically
actionable events (CAEs) more quickly than routine follow-up care of
transtelephonic monitoring (TTM) and in-office visits. Medtronic Inc.
(NYSE: MDT) sponsored the PREFER (Pacemaker Remote Follow-up
Evaluation and Review) trial, which was presented today as a late
breaking clinical trial by Bruce Wilkoff, M.D., Director of Cardiac
Pacing and Tachyarrhythmia Devices, Department of Cardiovascular
Medicine, Cleveland Clinic, and Professor of Medicine at Cleveland
Clinic Lerner College of Medicine, Case Western Reserve University.

   "In the trial we found that by following patients through the
Medtronic CareLink Network every three months - and thus having
quarterly access to device diagnostics - clinicians are able to more
quickly identify the occurrence of clinically actionable events," said
Dr. Wilkoff, principal investigator for PREFER.

   For example, physicians who remotely monitored patients with the
Medtronic CareLink Network more quickly detected new onset atrial
fibrillation (AF) in patients with no known history. Untreated AF - a
rapid irregular heartbeat in the upper chambers (atria) - can lead to
stroke.

   PREFER was a prospective, randomized, parallel, unblinded trial
involving 980 pacemaker patients at 50 centers in the United States.
The primary objective was to compare the rate of first diagnosis of
CAEs between patients who utilize the Medtronic CareLink Network
(REMOTE arm) versus patients who are followed via routine office
visits augmented by TTM (TTM arm). Secondary objectives were to
characterize the frequency of actions taken in response to CAEs, and
to compare the rate of first diagnosis of single types of CAEs. CAEs
included physiologic changes such as new onset atrial fibrillation
(AF), uncontrolled ventricular rate in AF, ventricular tachycardia,
and device integrity alerts affecting leads, pulse generators or
batteries.

   Patients in the REMOTE group had scheduled pacemaker
interrogations transmitted via the Medtronic CareLink Network at 3, 6,
and 9 months after enrollment, and an in-office evaluation at 12
months post-enrollment. TTM patients with a dual-chamber devices
transmitted 30-second EKG strips at 2, 4, 6, 8 and 10 months after
enrollment, with in-office evaluations at 6 and 12 months. TTM
patients with a single-chamber pacemaker transmitted data via TTM
instead of an in-office evaluation at 6 months.

   PREFER demonstrated that utilization of the Medtronic CareLink
Network resulted in a statistically significant improvement in the
rate of first diagnosis of clinically actionable events between the
602 patients in the REMOTE arm and the 295 patients in the TTM arm
(less than 0.0001). There were 272 patients in the REMOTE arm and 111
patients in the TTM arm in which the investigator detected an event.

   "Intuitively, one might think that increased frequency of
information as available via TTM would be beneficial in catching these
clinically actionable events," said David M. Steinhaus, M.D., vice
president and medical director of the Cardiac Rhythm Disease
Management business at Medtronic. "However, despite frequency, the
limited point-in-time EKG information provided by TTM didn't uncover
the potential for serious cardiac events as early as the more
comprehensive data provided for the remote group. This has important
implications for patient care by using remote management systems such
as the Medtronic CareLink Network."

   How it Works

   The Medtronic CareLink Network enables patients to transmit data
from their implantable device, as instructed by their physician, using
a portable monitor that is connected to a standard telephone line.
Within minutes, the patient's physician and nurses can view the data
on a secure Internet Web site. Available information includes
arrhythmia episode reports and stored electrograms along with device
integrity information, which is comparable to the information provided
during an in-clinic device follow-up visit, and provides the physician
with a view of how the device and patient's heart are operating. The
system provides an efficient, safe and convenient way for specialty
physicians to optimize patient care by remotely monitoring the
condition of their patients and, if needed, make adjustments to
medication or prescribe additional therapy.

   The Medtronic CareLink Network has been the leading Internet-based
remote patient monitoring system since its introduction in the United
States in 2002. Today, more than 250,000 patients at nearly 2,400
clinics in 20 countries are followed remotely, saving patients time by
eliminating in-office visits, and allowing physicians to perform a
complete analysis of all the device- and patient-specific cardiac data
stored within Medtronic patients' ICDs, pacemakers and CRT-D devices.

   The Medtronic CareLink Network has registered 1 million patient
data transmissions since the service's inception.

   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.

Medtronic, Inc.
Public Relations:
Tracy McNulty, 763-526-2492
On-site at HRS: 612-819-2190
or
Investor Relations:
Jeff Warren 763-505-2696
On-site at HRS: 612-819-7630

Copyright Business Wire 2008
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