Medtronic Announces Launch of DIVERGENCE(TM) Stand Alone Interbody Cage
May 04 2015 - 2:00PM
DUBLIN - May 4, 2015 -
Medtronic plc (NYSE: MDT), today announced the launch of the
DIVERGENCE(TM) Stand Alone Interbody Cage. This device is now
commercially available for the treatment of anterior cervical
interbody fusion procedures in skeletally mature patients with
cervical disc disease at one level from the C2-C3 disc to the C7-T1
disc. The announcement was made during the 83rd annual meeting of
the American Association of Neurological Surgeons (AANS) in
Washington, DC.
The DIVERGENCE(TM) Stand Alone Interbody Cage
represents Medtronic's latest technology for anterior cervical
discectomy with fusion (ACDF) procedures. It features an all-in-one
fusion device with internal screw fixation, allowing for maximum
distance from the adjacent level disc. Literature shows that
maximizing that distance may lower the incidence of Adjacent Level
Ossification Development (ALOD) or bone growth next to the treated
leveli. This
device also incorporates divergent screw technique, which reduces
retraction and incision.
"With this latest addition, the breadth of
Medtronic's updated cervical portfolio allows surgeons to treat
most anterior cervical pathologies they encounter in the operating
room from complex to degenerative with a number of options from
which to choose," 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 DIVERGENCE(TM) screws feature a
cortical cancellous thread design to help maximize bone screw
purchase and both straight and angled instrumentation.
"Divergence offers an elegant surgical solution
for a variety of cases, even for patients whose anatomy is
unfavorable for the use of standard plate and screws, said Dr.
Jean-Pierre Mobasser of the Goodman Campbell Brain and Spine
Institute in Indianapolis, IN. The Divergence Stand Alone
Interbody Cage's internal screw fixation and wide array of size
options provide a versatile solution for surgeons. Unique,
divergently angled screws and angled instrumentation also help to
minimize incision and exposure."
About the DIVERGENCE(TM) Anterior
Cervical Fusion System
The DIVERGENCE(TM) Anterior Cervical Fusion System consists of a
stand-alone interbody device indicated for use in anterior cervical
interbody fusion procedures in skeletally mature patients with
cervical disc disease at one level from the C2-C3 disc to the C7-T1
disc. Cervical disc disease is defined as intractable radiculopathy
and/or myelopathy with herniated disc and/or osteophyte formation
on posterior vertebral endplates producing symptomatic nerve root
and/or spinal cord compression confirmed by radiographic studies.
The DIVERGENCE(TM) stand-alone cervical interbody device must be
used with internal screw fixation. The DIVERGENCE(TM) stand-alone
cervical interbody device is also required to be used with
autogenous bone graft and is to be implanted via an open, anterior
approach. This cervical device is to be used in patients who have
had six weeks of non-operative treatment. Patients with previous
non-fusion spinal surgery at involved level may be treated with the
device.
Risks of the DIVERGENCE(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 DIVERGENCE(TM) Anterior Cervical Fusion System
incorporates the technology of
Gary K. Michelson, MD.
About Medtronic
Spinal
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's therapies can be
found at the business unit's patient-education website,
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-
i 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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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
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