coflex - Spine Group Beverly Hills

FDA TESTED AND APPROVED
The coflex® device was studied and compared to
pedicle screw fusion surgery after decompression in an
FDA clinical study.
The coflex® patients outperformed fusion patients in
all clinical measurements.*
• The coflex® surgeries were 36% faster
• The coflex® patients had less blood loss
• T he coflex® patients stayed one less day in the hospital
More coflex® patients were satisfied with their
outcomes compared to fusion patients.*
The majority of coflex® patients experienced:
• Significant pain relief at six weeks
• Lasting relief of symptoms at two years
• 9 4% were satisfied with outcomes at two years
RISKS
As a patient, there is always potential risk in having surgery
or when receiving a medical device. Usually these risks are
rare and the coflex® Patient Labeling should be referred to
for a list of all potential risks and hazards observed during
the clinical study. For patients receiving the coflex®device,
the risks included continued pain, wound healing
problems (such as infection or drainage), brief numbness
or tingling in the arms or legs, and bone fractures. In some
patients, the coflex® device may not help your pain, and
you may need another surgery to remove the device. It is
hard to predict who will not benefit from this surgery.
THE coflex® Interlaminar Stabilization™
Device
The only FDA-approved device offering motion
preserving, non-fusion stabilization after a surgical
decompression for moderate-to-severe spinal
stenosis.
Please refer to the FDA Patient Labeling or ask your
doctor about all warnings, precautions, and who should
be implanted with the coflex® device. The Patient
Labeling or your doctor can provide a description of the
risks and benefits of the coflex® device, as well as clinical
data showing that the coflex® device is safe
and effective.
Discuss your alternatives with your physician and
select the treatment method that best seems to meet
your current pain level and lifestyle. This content is for
educational purposes only and does not replace having
a conversation with your doctor.
If you are experiencing
symptoms from lumbar spinal
stenosis, consider the new
non-fusion solution
coflex®
Interlaminar Stabilization™
The spinal stenosis
treatment
option that gets you
walking again!
With coflex® I have my life
back on track.
— Andrea, 48 years old, coflex® patient,
mother of two
*This data is based on validated pain and function measurements from a randomized FDA
clinical study comparing the coflex® Interlaminar Technology to pedicle screw fusion surgery
for moderate-to-severe spinal stenosis. Every patient is different; therefore, results may vary.
All data is on file at Paradigm Spine, LLC.
These materials were prepared by Paradigm Spine, LLC, and distributed by
your local healthcare professional.
UPM10072 Rev. A
coflex®
The coflex® device could help alleviate the
weakness, tingling, numbness, stiffness or
cramping in your lower back or legs — to help
you become independent and functional again.
coflex®
LUMBAR SPINAL STENOSIS (LSS)
TREATMENT OPTIONS
• L SS is a narrowing of the spinal canal in the lower back
reducing the spinal nerves’ ability to exit to the lower
extremities
Conservative Therapy
The treatment of spinal stenosis usually starts with
non-surgical options, including:
• A
s we age, numerous factors can cause LSS — most
common is the “wear and tear” that occurs during the
natural aging and degeneration process
•
•
•
•
•
• A
s a result, the nerves in the lumbar spine become
pinched, and may cause intense back pain, weakness
and numbness in the legs, buttocks and lower back
• Pain from LSS may dramatically increase when walking
or during physical activity and may be relieved by sitting
or leaning forward
Healthy Spinal Canal
Rest or restricted activity
Weight loss
Pain medication
Chiropractic care
Massage therapy
•
•
•
•
Acupuncture
Physical therapy
Exercise
Injections
Surgical Treatment Options
In many cases, spinal stenosis pain cannot be controlled
with non-surgical treatments, and the doctor will
typically recommend either a surgical decompression, or
decompression with spinal fusion.
Surgical Decompression
• The surgeon removes the bone and soft tissue causing
the stenosis, relieving the pressure on the spinal nerves
• T his often causes the spine to become unstable — in
some cases, spinal fusion may be required to restore
stability
Narrowed Spinal Canal
Spinal Fusion
• Following decompression, the surgeon performs a
procedure to fuse the vertebrae bones together
• T his stops the motion in the unstable portion of the
spine, resulting in diminished natural movement
As decompression often results in spinal instability,
the coflex® device has been designed to provide
an alternative to spinal fusion — offering stability
without the loss of movement!
I feel like coflex®
has given me
hope again.
— Laura, 38 years old,
coflex® patient, mother of three
coflex®
It would be worthwhile for
anyone to look at coflex® as an
option if it’s applicable for their
situation.
— Michael, 36 years old,
coflex® patient
WHAT IS THE coflex®
DEVICE?
The coflex® device is a small,
U-shaped titanium implant that
is placed in the back of the
spine after decompression,
providing stability while maintaining
natural mobility. Following surgical
decompression, the surgeon inserts the
coflex® device through the same incision until it
is positioned on the laminar bone, which is the
strongest bone in the back of the spine.
1 - Vertebra
2 - Disc
3 - Foramen
4 - Spinous Process
5 - Nerve
6 - coflex®
7 - Lamina
1
2
4
5
6
3
7
HOW coflex® WORKS
The coflex® device is specifically designed to help keep
the spine stable after decompression surgery.
The coflex® device doesn’t fuse your vertebral bones
together, so motion and natural movement are
maintained at the operated area, as well as in the
neighboring parts of the spine.
It is strong yet simple, and flexible enough to support
the spine without having to fuse bones together.
The coflex®
device allows the
vertebral bones
to move in a
controlled way so
the decompressed
area is not
unnaturally
stiffened or fused!