For best results when printing this announcement, please click on the link below:
Second-generation MR-Conditional Pacemaker Combines Advanced Pacing Technology with MRI Access
MINNEAPOLIS - February 13, 2013 - Showcasing its leadership position in pacing technologies,
Medtronic, Inc. (NYSE: MDT), today announced the U.S. Food and Drug Administration (FDA) approval
and U.S. launch of its Advisa DR MRI(TM) SureScan(R) pacing system. The Advisa MRI system is
Medtronic's second-generation MR-Conditional pacemaker and is the first system to combine the most
advanced pacing technology with proven MRI access.
MRI is the standard of care in soft tissue imaging, providing information not seen with X-ray,
ultrasound or CT scans, and is critical for early detection, diagnosis and treatment. Advisa MRI
was specifically tested and approved for use as labeled with MRI scanners in the U.S. Of the 156
patients scanned in the Advisa MRI Clinical Trial, none showed any MRI-related complications. The
new system includes an Advisa MRI device and two CapSureFix MRI(TM) SureScan(R) leads, which must
be used together.
"Your physician can implant a pacemaker with advanced options that will allow for broad access to
MRI scanning," said Dr. J. Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville,
Tenn. "MRI is just so very important and traditional pacemakers not FDA approved for MRI scanning
often prevent the patient from having an MRI when they need it. With more than 85 percent of
pacemaker patients being at least 65 years old and having multiple comorbidities for which MRI may
be needed, it's key that physicians and patients have a pacing system that allows MRI imaging as a
The first SureScan pacemaker system was introduced in Europe in 2008 and its use in the MRI
environment is supported by clinical studies and extensive computer modeling, as well as
real-world data. To date, more than 100,000 Medtronic SureScan devices have been sold
worldwide; #_edn1 and, in the U.S., it is estimated that more than 10 percent of patients with
SureScan pacing systems have received MRIs. #_edn2 These patients received Medtronic's
first-generation Revo MRI(R) SureScan(R) pacing system, which was the only FDA approved (February
2011) MR-Conditional pacemaker in the U.S. before the Advisa MRI system.
Until the availability of Medtronic's SureScan pacing systems, patients with pacemakers in the
U.S. have been contraindicated from receiving MRI scans because of potential interactions between
the MRI and device function. According to published literature, up to 75 percent of patients
worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of
their devices. #_edn3
Advisa MRI - Medtronic's MRI Pacing System with Innovative Technology
Medtronic's Advisa MRI pacing system provides physicians with innovative technology that will
benefit their patients, including the MVP(R) (Managed Ventricular Pacing) algorithm, which is
proven to reduce unnecessary ventricular pacing. #_edn4 Additional Advisa features include:
*Complete automaticity with Ventricular and Atrial Capture Management(TM) (VCM and ACM) to
eliminate manual threshold checks and extend longevity of the device by up to one year.
*(R)Diagnostics, such as the Cardiac Compass Report, and AF management tools that assist
physicians in the early detection and treatment of atrial fibrillation.
*(R)Remote monitoring via Medtronic's CareLink Network, which transmits comprehensive arrhythmia
and diagnostic device data to a physician's clinic.
*, Rate Drop Response that identifies abrupt cardiac slowing and responds by pacing the
heart at an elevated rate, which may reduce the frequency of syncope (fainting) in patients with
apparent cardio-inhibitory vasovagal syncope.
*Highupper tracking rate to provide pacing support at higher heart rates for active and younger
This system is the latest addition to a growing number of Medtronic devices which are designed for
MRI access including the SynchroMed(R) II programmable drug infusion system available worldwide,
and the SureScan(R) neurostimulation systems for the management of chronic pain which are
available in Europe. In addition, SureScan(R) pacing systems - including Advisa MRI - are
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers
the broadest range of innovative medical technology for the interventional and surgical treatment
of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and
services that deliver clinical and economic value to healthcare consumers and providers around the
Medtronic, Inc. (www.medtronic.com http://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 periodic reports on file with the Securities and Exchange Commission. Actual results
may differ materially from anticipated results.
 #_ednref1 Medtronic data on file. November 27, 2012.
 #_ednref2 Medtronic data on file. November 5, 2012.
 #_ednref3 Kalin R and Stanton MS. Current clinical issues for MRI scanning of pacemaker and
defibrillator patients. PACE 2005;28:326-328.
 #_ednref4 Gillis AM, Pürerfellner H, Israel CW, et al. Reduction ofunnecessary ventricular
pacing due to the Managed
Ventricular Pacing (MVP) mode in pacemaker patients: Benefit for both sinus node disease (SND) and
AV block (AVB) indications. Heart Rhythm. May 2005;2(5):S40. Abstract AB21-1.
 #_ednref5 Rosenthal LS, Mester S, Rakovec P, et al. Factors influencing pacemaker generator
longevity: results from the complete automatic pacing threshold utilization recorded in the
CAPTURE Trial. Pacing Clin Electrophysiol. August 2010;33(8):1020-1030.
 #_ednref6 Nordlander R, Hedman A, Phersson SK. Rate responsive pacing and exercise capacity-a
comment. PACE. 1989;12:749-751.
 #_ednref7 Stone J, Crossley G. Current sensor technology for heart rate modulation by
artificial pacing. Clinical Electrophysiology Review. 1999;3:10-14.
For more information, visit www.jointhepacemakers.com/mri http://www.jointhepacemakers.com/mri
Advisa DR MRI™ SureScan® video http://wwwp.medtronic.com/newsroom/content/1360683874773.mp4
Advisa DR MRI™ SureScan® image http://hugin.info/152439/R/1677482/547067.jpg
This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients.
The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic, Inc. via Thomson Reuters ONE