Medtronic Receives FDA Clearance for ZEVO(TM) Anterior Cervical Plate System
May 04 2015 - 10:00AM
DUBLIN - May 4, 2015
-Medtronic plc (NYSE: MDT) announced it has received 510(k)
clearance from the U.S. Food and Drug Administration (FDA) to
market the ZEVO(TM) Anterior Cervical Plate System. This system is
now commercially available for the treatment of cervical
degenerative disc disease, trauma, tumors, deformity,
pseudoarthrosis, and/or failed previous fusions.
The ZEVO System represents Medtronic's latest
technology for anterior cervical discectomy with fusion (ACDF)
procedures. It features shorter plating options coupled with
hyper-screw angulations, allowing the physician to select the
smallest possible plate for the patient's individual surgical needs
while securing the plate as far as possible from the adjacent
disc.[1] Literature
shows this technique may lower the incidence of Adjacent Level
Ossification Development (ALOD) or bone growth next to
the treated level[1].
"Versatility is important in ACDF procedures, and
the ZEVO(TM) Anterior Cervical Plate System was designed to give
surgeons more options," said Doug King, president of the Spinal
business and senior vice president of Medtronic. "This system
represents Medtronic's commitment to responding to surgeon needs,
and innovating in ways that improve patient treatment and
care."
Additionally, the ZEVO System features
lower-profile plates with minimal thickness (1.9mm and 2.1mm) while
increasing the stability of the construct for the 4-5 level
options.
"Improved, thinner plates are important in ACDF
procedures," said Dr. Richard Hynes, spine surgeon at The B.A.C.K.
Center in Melbourne, FL. "ZEVO embodies these characteristics, with
the added benefits of hyper screw angulations, which can be
directed away from the spinal cord."
About the ZEVO(TM) Anterior
Cervical Plate System
The ZEVO(TM) anterior cervical plate and bone screw components are
intended for anterior interbody screw fixation from C2-T1. The
indications and contraindications of spinal instrumentation systems
should be well understood by the surgeon. The plate and bone screw
components are indicated for use in the temporary stabilization of
the anterior spine during the development of spinal fusions in
patients with: 1) degenerative disc disease (as defined by neck
pain of discogenic origin with degeneration of the disc confirmed
by patient history and radiographic studies), 2) trauma (including
fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis,
or scoliosis), 5) pseudoarthrosis, and/or 6) failed previous
fusions.
Risks of the ZEVO(TM) Anterior Cervical Fusion
System include but are not limited to early or late loosening of
any or all components and the development of new radiculopathy,
myelopathy or pain, and/or tissue or nerve damage caused by
improper positioning and placement of implants or instruments.
The ZEVO(TM) Anterior Cervical Fusion System incorporates the
technology of Gary K. Michelson, MD.
Multimedia Release
A multimedia version of this release, with downloadable graphics
can be found at: http://bit.ly/1dxgydH
About Medtronic's Spinal
Business
Medtronic's spinal business, based in Memphis, Tenn., is the global
leader in today's spine market and is committed to advancing the
treatment of spinal conditions. Medtronic's spinal business
collaborates with world-renowned surgeons, researchers and
innovative partners to offer state-of-the-art therapies for spinal,
neurological, orthopaedic and oral maxillofacial conditions.
Medtronic is committed to developing affordable, minimally invasive
procedures that provide lifestyle friendly surgical therapies.
More information about spinal treatments can be found at its
patient-education Web site, www.back.com.
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] Lee et al.
Anterior cervical plating technique to prevent adjacent-level
ossification development. The Spine Journal 13 (2013)
823-829.
Contacts:
Victor Rocha
Public Relations
+1-901-399-2401
Jeff Warren
Investor Relations
+1-763-505-2696
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Source: Medtronic plc via Globenewswire
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