Medtronic Launches Revamped Minimally Invasive Spine Fusion Procedures
July 15 2016 - 10:00AM
Innovative
Procedural Solutions Offer Efficiencies for Surgeons Using a
Lateral Approach
DUBLIN - July 15, 2016 -
Medtronic plc (NYSE: MDT) today announced the continued development
of the OLIF Platform with the launch of the PivoxTM
Oblique Lateral Spinal System with Lateral Plate for
OLIF25TM and
Divergence-LTM
Anterior/Oblique Lumbar Fusion System for OLIF51TM at the
International Meeting on Advanced Spine Techniques (IMAST) in
Washington, D.C. Lumbar interbody fusions aim to stabilize the back
by fusing two or more vertebrae with bone grafts or devices.
Oblique Lateral Interbody Fusion (OLIF) is a surgical technique
that minimizes cutting to muscles and addresses unmet needs seen
with traditional lateral approaches by utilizing an oblique-lateral
trajectory to access multiple levels of the lumbar spine. Compared
to traditional approaches, the OLIF25 and OLIF51 Procedures:
- Use minimally invasive techniques that minimize
muscle disruption,
- Allow for increased access to certain levels of
the spine, and
- Employ direct visualization to ensure an approach
to the disc space free from vascular, peritoneal, and nerve
obstructions.
The OLIF25 Procedure helps surgeons preserve the
patient's psoas muscle when treating the L2-L5 levels of the spine
and gives surgeons easier access around the patient's iliac crest -
enabling placement of an implant into the disc space for anterior
column support. It also reduces patient positioning steps and
allows for a more upright surgeon posture with direct visualization
of the disc space, psoas muscle, and anterior longitudinal
ligament. The OLIF51 Procedure provides lateral access to the L5-S1
disc space and doesn't require surgeons to reposition the patient
if multiple levels of surgery are conducted. The incision for the
OLIF51 technique spares the abdominal muscles and allows gravity to
aid in retraction. OLIF Procedures incorporate Medtronic's
comprehensive surgical platform of access, interbody, navigation,
fixation and biologic options.
"In my opinion, OLIF is one of the least invasive
manners in which to achieve successful fusion in the lumbar spine.
OLIF minimizes disruption of the tissues surrounding the spine,
particularly the psoas muscle and the embedded nerves. There is no
need to use neuromonitoring, and the entire procedure can be done
without repositioning the patient," said Kamal R. Woods, MD, FAANS,
a neurosurgeon at Advanced Neurosurgery Associates in Murrieta, CA.
"As with any anterolateral procedure, safe access to the spine is
critical. The OLIF25 and OLIF51 retractor systems enhance the ease
and reproducibility of the procedure."
The Pivox Oblique Lateral Spinal System with
Lateral Plate is an innovative interbody cage and plate engineered
for the OLIF25 procedure. It can be used together at one or two
contiguous levels from L2 to S1 without the need for additional
posterior fixation.
The Divergence-L Anterior/Oblique Lumbar Fusion
System is the first plate/interbody all-in-one system for both the
OLIF51 procedure and the ALIF procedure. The Divergence-L system
has specifically designed plates for the oblique or anterior
approach and has a large footprint with multiple height and
lordosis options to provide desired disc height and segmental
lordosis.
"Our goal is to enable the best possible patient
care, so we continue to innovate and evolve spine surgery to
address unmet needs," said Doug King, senior vice president and
president of Medtronic's Spine division, which is part of the
Restorative Therapies Group at Medtronic. "The OLIF Procedures
represent an evolution in lateral access, and we're pleased to see
more surgeons undertaking this evolution in their approach."
Risks associated with minimally invasive spine
surgery include transitioning to a conventional open procedure,
neurological damage, damage to the surrounding soft tissue, and,
where used, instrument malfunction. Other risks associated with
implants used include device migration, nonfusion, loss of spinal
curvature, correction, height, and/or reduction. Minimally invasive
procedures may be associated with longer operative times.
In the United States, more than 250,000
individuals with a variety of spinal conditions, like degenerative
disc disease or deformities, undergo spinal fusions annually to
treat degenerative changes in the lumbar spine.
About Pivox Oblique Lateral
Spinal System
Cage
-
Use with autograft and/or allogenic bone graft
comprised of cancellous and/or corticocancellous bone graft to
facilitate interbody fusion;
-
In patients with Degenerative Disc Disease (DDD)
at one or two contiguous levels from L2 to S1, with or without up
to Grade 1 Spondylolisthesis or retrolisthesis at the involved
levels; used with supplemental fixation cleared for use in the
lumbar spine; and
-
To provide anterior column support in patients
with degenerative scoliosis as an adjunct to pedicle screw
fixation.
Plate and Screws
-
Supplemental fixation: Oblique or lateral L1-L5
above the vascular structures bifurcation; anterior L5-S1 below the
bifurcation;
-
Temporary stabilization in patients with DDD;
trauma; tumors; deformity; pseudarthrosis; and/or failed previous
fusions.
Cage with Plates and
Screws
About Divergence-LTM
Anterior/Oblique Lumbar Fusion System
Plate and Bone Screws
-
Supplemental fixation: Anterior oblique L1-L5
above the vascular bifurcation; anterior L5-S1 below the
bifurcation;
-
Temporary stabilization in patients with
Degenerative Disc Disease (DDD); trauma; tumors; deformity;
pseudarthrosis; and/or failed previous fusions.
Interbody Cage
-
Interbody fusion in patients with DDD at one or
two contiguous levels from L2 to S1, with or without up to a Grade
1 Spondylolisthesis or retrolisthesis at the involved levels.
-
Required use with autogenous bone graft
-
Intended use with supplemental fixation cleared
for use in the lumbar spine. Cages with a lordosis of 18º or
greater must be used with at least supplemental anterior
fixation.
When used together, Divergence-L components can be
used only in patients with Interbody Cage indications.
The PivoxTM Oblique
Lateral Spinal System with Lateral Plate for OLIF25TM and
Divergence-LTM
Anterior/Oblique Lumbar Fusion System for OLIF51TM
incorporate the technology of Gary K. Michelson, MD.
About Medtronic's Spine
Division
We shape spine surgery for the better - delivering smart procedures
and therapeutic biologics. As a global leader, we partner with
other healthcare stakeholders to accelerate innovations that can
improve surgical efficiencies and help create better outcomes for
more patients. More information about spinal treatments can be
found at our patient education Web site, www.back.com.
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-
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Victor Rocha
Public Relations
+1-901-399-2401
Ryan Weispfennig
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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