Medtronic's StealthStation® Cranial Software Receives FDA Clearance as an Aid for Deep Brain Stimulation Lead Placement
September 26 2016 - 8:01AM
The Company
Continues to Pioneer Innovations in Deep Brain Stimulation and
Surgical Technologies by Launching the Only Fully-Integrated
Procedural Solution for Neurosurgery
DUBLIN and SAN DIEGO - September
26, 2016 - Medtronic plc (NYSE: MDT) today announced U.S. Food
and Drug Administration (FDA) clearance of StealthStation® Cranial
Software as an aid for deep brain stimulation (DBS) lead placement.
The software is fully integrated with Medtronic's latest O-arm®
Imaging System, providing clinicians with a complete procedural
solution for the planning and placement of DBS leads. The
announcement was made at the Congress of Neurological Surgeons
(CNS) in San Diego.
With Medtronic's DBS Therapy, a small,
pacemaker-like device called a neurostimulator is implanted under
the skin of the chest and sends electronic signals to an area in
the brain that controls movement. Thin wires - called leads - are
implanted in the brain and are connected to the neurostimulator by
an extension to enable the signals to reach the source of symptoms.
The new StealthStation application, which integrates pre-operative
planning, intraoperative imaging and technologies to help guide
surgeons during cranial procedures, is designed to improve
procedural workflow and allow for DBS lead placement with a high
level of accuracy.
"The new StealthStation software works seamlessly
with O-arm to give me a single solution for pre-operative planning
and real-time 3D imaging of the brain in the OR, and that
streamlines my workflow for DBS lead placement," said Dr. Jonathan
Carlson, MD, PhD, a neurosurgeon at Providence Spokane Neuroscience
Institute in Spokane, Wash. "Now I have the essential information I
need in one place, giving me - and my patients - even more
confidence in the procedure."
In the past 25 years, the StealthStation system
has been used in more than 2.25 million procedures. The O-arm
system has been used to help more than 200,000 patients over the
past decade. Medtronic DBS neurostimulators have been implanted in
over 140,000 patients around the world. Medtronic's full-body MR
Conditional Activa® DBS neurostimulators help to reduce some of the
movement symptoms of certain neurological disorders including
Parkinson's disease and essential tremor.
"We alleviate pain, restore health and extend life
by providing informed and integrated neurosurgical procedures to
our customers and their patients," said Scott Hutton, vice
president and general manager of the Neurosurgery business in
Medtronic's Restorative Therapies Group. "And as we transform the
way the world treats patients with neurologic disorders, we'll
utilize the breadth of our broad Brain Therapies portfolio in new
and different ways to bring fully-integrated solutions like this to
our customers."
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 88,000 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-
Contacts:
Sara Thatcher
Public Relations
+1-901-399-2098
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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