Medtronic Neurosurgery Receives Expanded Indications for the StealthStation® Electromagnetic Surgical Navigation Technology
May 04 2015 - 8:00AM
Catheter and
Electrode Placement Now FDA-cleared for Adult and Pediatric Patient
Procedures
DUBLIN - May 4, 2015 -
Medtronic plc (NYSE: MDT) today announced that it has received
clearance from the U.S. Food and Drug Administration (FDA) for
expanded indications of specific StealthStation® electromagnetic
(EM) surgical navigation system instruments for pediatric and adult
cranial and ENT procedures.
The clearance for these StealthStation
electromagnetic instruments enables additional neurosurgical
applications that can benefit from flexible, tip-tracked
instruments for both pinned and pin-less procedures. The navigated
instruments can be used with compatible devices to aid in the
placement of ventricular catheters for adult and pediatric
patients; shunt systems; connection to Ommaya reservoirs; hematoma
drainage; external ventricular drainage catheters; neuroendoscope
peel-away catheters; and for the placement of
depth-electrodes[1].
"This expanded indication of the StealthStation
electromagnetic surgical navigation system instruments is very
exciting for our business," said Scott Hutton, vice president and
general manager of Medtronic Neurosurgery, a business in
Medtronic's Surgical Technologies division. "It expands the scope
of neurosurgical procedures that can benefit from the unique
features of EM navigation - such as depth electrode placement for
epilepsy seizure monitoring, and pin-less, MRI-conditional patient
tracking during intraoperative MRI imaging. This is an achievement
for the neurosurgical community, and represents our commitment
toward advancing this innovative technology to benefit
patients."
StealthStation EM surgical navigation was
developed by Medtronic in 2002. It is the most widely used EM
navigation technology in the ENT and neurosurgery space with over
2,000 systems in use. With more than 70 patents issued and pending,
Medtronic is the leader in cranial electromagnetic navigation.
About StealthStation
Electromagnetic Surgical Navigation
Medtronic StealthStation electromagnetic surgical navigation
system is a proprietary tracking technology that uses unique
engineering to generate an electromagnetic field around a patient's
targeted anatomy, triangulating the position of instruments
relative to patient-tracking devices during surgical navigation
procedures.
The StealthStation system is intended as an aid
for precisely locating anatomical structures in either open or
percutaneous procedures. The StealthStation system is indicated for
any medical condition in which the use of stereotactic surgery may
be appropriate, and where reference to a rigid anatomical
structure, such as the skull, a long bone, or vertebra, can be
identified relative to a CT-based or MR-based model, fluoroscopy
images, or digitized landmarks of the anatomy. Procedures include
general ventricular catheter placement; pediatric ventricular
catheter placement; tumor resections; skull base procedures;
craniotomies/craniectomies; and transsphenoidal procedures.
About Medtronic Surgical
Technologies
Part of Medtronic's Restorative Therapies Group, Surgical
Technologies develops products and procedural solutions for
surgical applications that include: neuro, spine, and orthopedics;
ear, nose and throat; and surgical oncology. Surgical Technologies
designs, develops, manufactures and supports healthcare providers
with advanced surgical navigation and imaging solutions, powered
surgical tools and systems, intraoperative nerve monitoring
devices, advanced energy-based devices for hemostatic sealing and
tissue dissection, and implantable devices for hydrocephalus
management.
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] Refer to
the StealthStation® Electromagnetic Stylet IFU for details
regarding compatible catheters and electrodes.
Contacts:
Natalie St. Denis
Public Relations
+1-303-917-7772
Jeff Warren
Investor Relations
+1-763-505-2696
This
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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
HUG#1917737
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