Medtronic Announces CE Mark and Launch for CapSureFix Novus(TM) 5076 MRI Lead
(Thomson Reuters ONE) -
Proven Lead Expands Access to MRI for Patients with Slow Heartbeat
TOLOCHENAZ - May 21, 2013 -- Medtronic today announced CE Mark (Conformité
Européenne) and launch of its CapSureFix Novus(TM)5076 Lead, which is now
approved in the EU for use in an MRI environment when paired with a Medtronic
MR-Conditional pacemaker. The lead has not been approved for that use in the
U.S.
The CapSureFix Novus 5076 Lead, previously approved for use with Medtronic's non
MR-Conditional pacemakers, has long been preferred by physicians because of its
small size, easy handling and proven reliability (98 percent reliability over
12 years). It is one of Medtronic's most frequently implanted pacing leads with
more than 2.8 million implants worldwide.
With CE Mark, this lead now can also be paired with Medtronic's SureScan® pacing
systems which are approved for use in an MRI environment. In addition, patients
who previously had the leads implanted (with non-MRI pacemakers) will have the
option to receive MRIs when their devices are changed at the time of battery
depletion, if their replacement devices are Medtronic MR-Conditional.
"With the lead's 98 percent reliability over the past 12 years, patients and
physicians can benefit from a lead that is proven to be dependable and now has
the added benefit of MR compatibility," said Brian Urke, vice president and
general manager of the bradycardia business at Medtronic.
The CapSureFix Novus 5076 Lead underwent extensive MRI testing - more than 1.5
million computer-modeled scenarios evaluating different patient body types,
scanning locations, MRI scanner types and lead lengths - to ensure its ability
to function properly in the MRI environment.
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 implanted worldwide(([i])). It is estimated that up
to 75 percent of patients worldwide with implanted cardiac devices are expected
to need an MRI scan during the lifetime of their devices.(([ii]))
MRI is the standard of care in soft tissue imaging, providing information not
seen with X-ray, ultrasound or CT scan. MRI is therefore critical for the early
detection, diagnosis and treatment of many diseases. And until recently,
patients with implanted pacemakers were denied access to MRI procedures because
the interaction can be harmful.(([iii]))(,([iv]),([v]),([vi]))
This 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 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, 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
results.
- end -
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[i] Medtronic data on file. November 27, 2012.
[ii] Kalin R and Stanton MS. Current clinical issues for MRI scanning of
pacemaker and defibrillator patients. PACE 2005;28:326-328.
[iii] Faris OP, Shein M. Food and Drug Administration perspective: Magnetic
resonance imaging of pacemaker and implantable cardioverter-defibrillator
patients. Circulation 2006;114:1232-1233.
[iv] Roguin A, Schwitter J, Vahlhaus C, et al. Magnetic resonance imaging in
individuals with cardiovascular implantable electronic devices. Europace
2008;10:336-346.
[v] Levine GN, Gomes AS, Arai AE, et al. Safety of magnetic resonance imaging in
patients with cardiovascular devices: an American Heart Association scientific
statement from the Committee on Diagnostic and Interventional Cardiac
Catheterization, Council on Clinical Cardiology, and the Council on
Cardiovascular Radiology and Intervention: endorsed by the American College of
Cardiology Foundation, the North American Society for Cardiac Imaging, and the
Society for Cardiovascular Magnetic Resonance. Circulation 2007;116:2878-2891.
[vi] Kalin R and Stanton MS. Current clinical issues for MRI scanning of
pacemaker and defibrillator patients. PACE 2005;28:326-328.
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
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originality of the information contained therein.
Source: Medtronic, Inc. via Thomson Reuters ONE
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Datum: 21.05.2013 - 19:00 Uhr
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