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Medtronics Reports FDA Approval Of Capsurefix Novus MRI Surescane 5076 Full-Body Scanners

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Medtronic today announced the U.S. Food and
Drug Administration (FDA) approval of its CapSureFix Novus(TM) MRI SureScan®
5076 Lead for use with magnetic resonance imaging (MRI). The lead is approved
for MRI scans positioned on any region of the body when paired with a
Medtronic dual-chamber MR-conditional pacemaker.

The 5076 lead, previously approved for use with Medtronic's non-MR-conditional
pacemakers, has been well-received because of its handling and proven
reliability. Since its introduction more than 10 years ago, physicians have
implanted more than 3 million 5076 leads in patients.^[i]^, [ii]

With the new FDA approval, two 5076 MRI leads can now be paired with
dual-chamber Medtronic Advisa MRI(TM) or Revo MRI(TM) SureScan® pacemakers,
allowing patients with these complete SureScan pacing systems to undergo
full-body MRI scans. Medtronic 5076 MRI lead lengths approved for these scans
range in length from 35cm to 85cm. Patients who previously had two 5076 leads
implanted with non-MRI pacemakers will have the option to receive MRIs if
MR-conditional SureScan pacemakers are implanted when replacement devices are

"The 5076 lead has proven to be one of the most reliable pacing leads for more
than a decade, and due to extensive testing, now also can undergo MRI scans,"
said Brian Urke, vice president and general manager of the bradycardia
business at Medtronic. "This is especially important for patients who need
MRIs and received 5076 leads at the time of their initial implants; although
they may not have received MR-conditional pacemakers initially, they now have
the option to get a pacemaker approved for MRI when they require a device
change-out, making the entire system MR-conditional."

Medtronic has spent more than 17 years studying the MRI environment, and was
the first in the industry to introduce a pacemaker system specifically
engineered for this purpose. Since its first MR-conditional pacing system was
approved in Europe in 2008, Medtronic has continued to design and test its
products for safe use during MRI scanning. Advances in computer modeling have
allowed Medtronic to vigorously evaluate the 5076 lead across more than 2
million scanning scenarios. ^^[iii] Medtronic also conducted the 5076 MRI
Clinical Study, a global, multi-center, study to evaluate the safety and
effectiveness of the 5076 lead in the MRI environment.

Worldwide, it is estimated that up to 75 percent of patients with implanted
cardiac devices are expected to need an MRI scan during the lifetime of their
devices.^^[iv] 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.
Until recently, patients with implanted pacemakers were denied access to MRI
procedures because the interaction can be harmful. ^^[v]^, ^[vi], ^[vii],

The 5076 MRI lead is the latest addition to a growing number of Medtronic
devices that are approved for MRI access. These include the Medtronic SureScan
pacing systems, the SureScan neurostimulation systems for the management of
chronic pain, and the SynchroMed^® II programmable drug infusion system, which
are available worldwide. Additionally, the Evera MRI(TM) SureScan implantable
cardioverter-defibrillator (ICD) system is investigational in the U.S.

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.

Posted-In: News FDA Press Releases


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