Medtronic Announces FDA Approval and Launch of Its Advisa MRI Pacemaker System
2013-02-13 15:03:02 -
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(®) 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(®)
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 diagnostic procedure."
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; and, in the U.S., it is estimated
that more than 10 percent of patients with SureScan pacing systems have received
MRIs. These patients received Medtronic's first-generation Revo MRI(®)
SureScan(®) 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
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(®) (Managed
Ventricular Pacing) algorithm, which is proven to reduce unnecessary ventricular
pacing. 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.
* Diagnostics, such as the Cardiac Compass(®) Report, and AF management tools
that assist physicians in the early detection and treatment of atrial
* 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
* Highupper tracking rate to provide pacing support at higher heart rates for
active and younger patients.
This system is the latest addition to a growing number of Medtronic devices
which are designed for MRI access including the SynchroMed(®) II programmable
drug infusion system available worldwide, and the SureScan(®) neurostimulation
systems for the management of chronic pain which are available in Europe. In
addition, SureScan(®) pacing systems - including Advisa MRI - are available
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), 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
 Medtronic data on file. November 27, 2012.
 Medtronic data on file. November 5, 2012.
 Kalin R and Stanton MS. Current clinical issues for MRI scanning of
pacemaker and defibrillator patients. PACE 2005;28:326-328.
 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.
 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
 Nordlander R, Hedman A, Phersson SK. Rate responsive pacing and exercise
capacity-a comment. PACE. 1989;12:749-751.
 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:
Advisa DR MRI™ SureScan® video:
Advisa DR MRI™ SureScan® image:
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Source: Medtronic, Inc. via Thomson Reuters ONE