Medtronic Expands MRI-Compatible Portfolio with FDA Clearance of StrataMR(TM) Shunt System
May 02 2016 - 10:00AM
Patients with
Hydrocephalus and CSF Disorders Have Greater Access to Full Body
MRI Scans with StrataMR
DUBLIN - May 2, 2016 -
Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug
Administration (FDA) clearance of StrataMR(TM) valves and shunts,
an addition to Medtronic's family of Strata® Adjustable Valve
Systems used in the treatment of patients with hydrocephalus and
cerebrospinal fluid (CSF) disorders. The StrataMR system is
intended to maintain its performance level setting during magnetic
resonance imaging (MRI) exposure when scanned in accordance with
labeling.
The clearance adds to Medtronic's portfolio of
systems designed for access to full-body MRI, such as pacemakers,
implantable cardioverter defibrillators (ICDs), deep brain
stimulation (DBS) systems, and spinal cord stimulators. The
StrataMR system will be available to physicians and their patients
in the coming months.
"Patients with hydrocephalus and CSF disorders
often require MRI," said Tom Poss, director of marketing in the CSF
Management business, which is part of the Restorative Therapies
Group at Medtronic. "The use of MRI has become a diagnostic
standard of care, allowing physicians to detect a wide range of
health conditions. And our StrataMR technology will offer
healthcare providers a level of confidence in the shunt's
performance should an MRI become necessary."
The StrataMR system is similar to the current
family of Medtronic Strata valves, which offers a variety of sizes
and configurations for hydrocephalus management. Strata valve
products contain a magnet inside the valve mechanism that allows
the neurosurgeon, as needed, to adjust the performance level
setting in his or her office. Although neurosurgeons should still
check performance levels after MRI exposure, the StrataMR system is
designed to resist setting changes in an MRI field of up to 3.0
Tesla.
"I see many implications for the use of the new
StrataMR, especially with patients who need to have their valves
re-checked after MR imaging," said Marion L. Walker, MD, a
professor of neurosurgery at the University of Utah. "Also, this
technology will benefit those patients who are concerned about
their exposure to strong magnets. This new technology may cut down
on some of the insecurities these patients may feel."
"The StrataMR system builds on the reliability and
convenience of Medtronic's Strata family of innovative therapies
for the CSF community," said Scott Hutton, vice president and
general manager of the Neurosurgery business, which is part of the
Restorative Therapies Group at Medtronic. "Innovation continues to
differentiate Medtronic. StrataMR now joins a growing number of
Medtronic therapies that allow greater access to MRIs, including
DBS systems, pacemakers, and ICDs."
About Hydrocephalus
The brain has its own circulatory system where cerebrospinal fluid
is produced, absorbed and transported to the venous system of the
sagittal sinus. Hydrocephalus is a condition where there is an
excess amount of CSF in the ventricles of the brain. Left untreated
hydrocephalus can result in enlarged heads, headaches, nausea and a
significantly reduced quality of life. In the U.S., more than 1
million children and adults1 are affected
with hydrocephalus and CSF disorders. The standard treatment of
hydrocephalus is to implant a shunt or a device designed to drain
CSF away from the nervous system to decrease the size of the
enlarged ventricles.
The Medtronic StrataMR Shunt
System
Click the thumbnail above for a larger
image.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 85,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
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-
References
1
http://www.hydroassoc.org/hydrocephalus/ accessed March 2015
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Public Relations
+1-904-332-8163
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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