Medtronic Announces Expansion of MR-Conditional Products with U.S. Launch of Advisa SR MRI(TM) SureScan® Pacing System
26 June 2015 - 1:00AM
Single-Chamber Pacemaker Allows
for Full-Body MRI Scans Without Positioning Restrictions
DUBLIN- June 25, 2015 -
Medtronic plc (NYSE: MDT), today announced the U.S. Food and Drug
Administration (FDA) approval and commercial launch of the Advisa
SR MRI(TM) SureScan®
single-chamber pacemaker with the 5076 MRI lead, which allows for
magnetic resonance imaging (MRI) scans positioned on any region of
the body without restrictions. The new system includes the Advisa
SR MRI pacemaker and a SureScan lead, which must be used together
to be considered MR-conditional.
MRI is the standard of care in soft tissue
imaging, providing information not seen with X-ray, ultrasound, or
CT scan, and without exposing patients to ionizing radiation. MRI
is critical for the early detection, diagnosis and treatment of
many diseases, including strokes, cancer, Alzheimer's disease, and
muscle, bone and back pain - all of which are prevalent among older
adults.
It is estimated that 50-75 percent of patients
with implantable cardiac devices will need an MRI scan over the
lifetime of their device.1 Until the
approval of MR-conditional pacemakers, patients with implanted
devices were typically denied access to MRI procedures because of
the potential for harmful interaction between the device and the
MRI scanner.
"MRI is a vital diagnostic tool that was not
available to pacemaker patients before Medtronic released the
world's first MR-conditional pacing system in 2008," said Brian
Urke, vice president and general manager of the bradycardia
business at Medtronic. "Through our work with clinicians, Medtronic
MR-conditional pacing systems have been evaluated in four clinical
studies with more than 3,600 patients, and today we offer the most
extensive portfolio of MR-conditional pacing devices and leads
available in the U.S."
In addition to delivering single chamber pacing
with the same SureScan® technology
used in other Medtronic cardiac devices, the new Advisa SR
MRI(TM) pacemaker
has improved diagnostic information and storage, and a 35 percent
improvement2 in battery
longevity (when compared to the Adapta® single
chamber pacing system).
The Advisa single chamber pacemaker is the latest
addition to a growing number of Medtronic devices that are designed
for MRI access including the Advisa DR MRI® and Revo
MRI® dual
chamber SureScan pacing systems, the Reveal LINQ®Insertable
Cardiac Monitoring (ICM) system, SureScan neurostimulation systems
and the SynchroMed® II
programmable drug infusion system which are available
worldwide.
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 world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, 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.
- end -
1 Kalin R and Stanton MS. Current clinical
issues for MRI scanning of pacemaker and defibrillator patients.
PACE 2005;28:326-328.
2 Rome, Sarah.
Advisa SR MRI SureScan Longevity Calculation. February 2015.
Medtronic Data On File.
Contacts:
Ryan Mathre
Public Relations
+1-763-514-9625
Jeff Warren
Investor Relations
+1-763-505-2696
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
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The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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