WARSAW2050
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00206
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`Direct lateral interbody fusion (DLIF) - Back surgery
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`spinal fusion allows access to the area to be treated while potentially minimizing disruption of the
`surrounding soft tissues and anatomical structures.
`
`The Interbody Fusion Approach to Spinal Stabilization
`
`Consisting of the five vertebrae (Ll-L5) of the lower back, the lumbar spine bears the greatest amount
`of the body's weight, making it a common source of back pain. Degenerative conditions, deformity
`and injury can lead to spinal instability which, if it results in pressure on the spinal cord and/or
`surrounding nerves, may ultimately cause back pain and other symptoms such as leg pain or muscle
`weakness that extends into the hips, buttocks and legs.
`
`If these symptoms persist for an extended period of time and have failed to respond to conservative
`treatment measures such as rest, medication, exercise and physical therapy, your surgeon may
`recommend a surgical procedure called spinal fusion. Spinal fusion is sometimes recommended to
`treat conditions of the lower back, including Degenerative Disc Disease. The goal of spinal fusion is
`to restore spinal stability, and the procedure typically involves removing the disc material from in
`between two adjacent vertebrae and then placing an implant and bone graft material into the disc
`space (interbody) to promote bone growth that permanently joins together the two vertebrae (fusion).
`Rods and screws are then placed posteriorly to create an "intemal cast" that supports the vertebral
`structure during the healing process. Click here to learn -more about the minimally. invasiv__e screw
`placement system, CD HORIZON® SEXTANT® II.
`
`Gaining clear access to the spine, for both visualization and treatment of the affected vertebrae, is one
`of the most critical aspects of spinal fusion surgery, and there are several different approaches a
`surgeon typically takes for an interbody-type procedure. They include approaching the spine from the
`front of the body through an incision in the patient's abdomen (anterior lumbar interbody fusion
`|ALIF| ), and approaching the spine through an incision in the patient's back over the vertebrae to be
`treated (posterior lumbar interbody fusion |PLIF'| or transforaminal lumbar interbody fusion |TLIF|.)
`Factors that influence a surgeon's decision on which approach to take include the spinal condition to
`be treated, its location in the spinal column, his or her own training and surgical experience, available
`technology and the patient's overall general health.
`
`The DLIF Difference
`
`The DLIF procedure is different from other interbody fusion techniques in that to approach the spine,
`the surgeon makes a small incision in the skin of the patient's side. Then, using minimally invasive
`surgical techniques, he or she creates a narrow passageway through the underlying soft tissues and the
`psoas muscle — gently separating the fibers of the psoas muscle rather than cutting through it —
`directly to the vertebra(e) and disc to be treated. This is called the trans-psoas, or Direct Lateral,
`approach to interbody spinal fusion.
`
`The DLIF technique involves dilating through the soft tissues of the side rather than approaching the
`spine through the abdominal cavity or through a longer incision in the back, and may cause less
`disruption of the muscles and soft tissues than these traditional "open" techniques.
`
`DLIF is one of several minimally invasive spine procedures available today. Other procedures, such
`as minimally invasivecdecompression or minimally invasive TLIF, may be recommended depending
`on your condition. The potential benefits of minimally invasive may include:
`
`- Shorter hospital staysl
`- Smaller incisions and scars
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`http ://www.back. com/treatment-surgical-direct.html
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`CONFIDENTIAL
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`7/12/2013
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`MNUV5059267
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`Direct lateral interbody fusion (DLIF) - Back surgery
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`- Decreased intraoperative blood loss;
`- Decreased post-operative medication needed while in the hospitall
`
`However, even though DLIF is a minimally invasive procedure, it's important to remember that it is
`still spine surgery, and therefore not without risk. Potential risks associated with surgery include
`anesthesia complications, blood clots, allergic reactions and adverse effects due to undiagnosed
`medical problems, such as silent heart disease.
`
`One Surgeon's View
`
`In recent years, the Direct Lateral approach to interbody fusion has gained favor with some spine
`surgeons. One is orthopedic surgeon Dr. Richard Hynes, staff physician with the Wuesthoff Medical
`Center in Melbourne, FL. Here, Dr. Hynes, the investigational team lead for a clinical trial on DLIF
`conducted at the Wuesthoff Center, shares his insights on the procedure.
`
`What have you found to be the benefits of the DLIF procedure?
`
`The DLIF approach is an alternative to other interbody fusion procedures, and I believe that for the
`right patient it can be an invaluable surgery. Its benefits stem from the fact that you're approaching the
`disc from the side rather than from the front or back, and that you're able to do this through a very
`small, l-2cm incision in the patient's side. What's there is mostly a little bit of muscle and fat, right
`behind the walls that hold the abdominal contents, it leads directly to the large psoas muscles that are
`attached to either side of the lumbar spine and overlay the discs. These muscles are large, and their
`fibers are easy to weave through to get to the side of the disc you're going to treat. You're not making
`any big incisions or cutting through muscles.
`
`DLIF is just one of several approaches to interbody fusion, and it's not for every patient. But, for those
`it is suitable for I've found it to be an excellent fit. In fact, I performed two yesterday — both of those
`patients were in and out of the OR in less than an hour and we were able to accomplish major
`stabilization with no blood loss. Of course, results vary depending on each patient's condition and the
`surgeon's skill level and training.
`
`For which patients have you found DLIF to be suitable?
`
`In my experience, I've found the best candidate to be a patient who requires interbody
`stabilization/fusion at the intervertebral levels above L4-L5, and who for some reason might not
`otherwise be considered a suitable candidate for an anterior or posterior approach. I've also found it to
`be a good option for patients who require what I call an "add-on" fusion — those who've had a
`previous fusion in their lower lumbar levels, and the discs above it are now requiring some
`stabilization, which can happen over time. With this approach, they can get stabilization and symptom
`relief without enduring another traditional, open spine surgery.
`
`Why I think it's best for patients who require stabilization above L4-L5 is that, when you're going in
`from the side at these lower levels of the spine, the iliac crest (hip bone) can get in the way of your
`trajectory. In my experience, the L2-L3 or L3-L4 disc levels are perfect for this procedure. We also
`use it routinely at L1-L2, but you have to go in at slightly more of an angle because you have to slip
`under that lower rib.
`
`As for patients who might benefit the most from a minimally invasive, Direct Lateral approach, I've
`found that DLIF offers some great advantages for those considered part of the "aging spine"
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`http ://www.back. com/treatment-surgical-direct.html
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`CONFIDENTIAL
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`7/12/2013
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`MNUV5059268
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`population. In our practice, we see a lot of older patients with multi-level degenerative disc disease
`and who, after having a previous fusion surgery maybe 10, 20 years ago, could now benefit from an
`add-on stabilization procedure. When you're dealing with a 70-80 year old, you really don't want to go
`in anteriorly — through the abdomen or chest — if you don't have to, because the risk of
`complications can be high. And the problem with a posterior approach is that many of these patients
`have osteoporosis, which can mean less potential for spinal fixation. The DLIF approach is a good
`option for these patients because it is a minimally invasive procedure.
`
`Do you think development of DLIF is part of a larger trend in treating spinal disorders?
`
`Yes, I think so. Over the past decade, the trend in spinal fusion surgery has evolved from the
`traditional, posterior approach with the implantation of bone graft from the hip, to the use of interbody
`implants, such as cages, and the development of BMP (bone morphogenetic protein) to achieve the
`goal of spinal stabilization. DLIF is another "next- generation" step in the process.
`
`Today, there are so many innovations available for spinal fusion surgery, and with so many nuances,
`it's almost as though you can design a custom-tailored surgery for every patient based on their
`condition, their size and anatomy and any other particular needs. We couldn't do that a decade ago.
`
`What advice would you give a patient who thinks they might be a candidate for a DLIF?
`
`The best advice I have for a patient who might be considering this or any other spinal fusion
`procedure is, "Do your homework!" Talk to your doctor, go to reputable Web sites such as Back.com
`and learn all about the procedure, as well as any other options that are available, both surgical and non
`-surgical. Get a second opinion on your condition and the treatment or procedure that's being
`recommended, ask your surgeon the pros and cons and how much experience they have performing it.
`
`Patients now have more options than ever, which is why they need to make sure they have an
`experienced, qualified surgeon; one who can and will come up with a treatment plan that's best suited
`to their specific needs and that incorporates the most effective surgical technology and techniques that
`are available today. There's no need for them to settle for the routine, "sa1ne-old, same-old" surgery
`that's been done for years, and that relies on outdated technology.
`
`DLIF 101: How It's Done
`
`For a minimally invasive DLIF procedure, the patient is positioned on their side on the operating table
`— this is called the lateral decubims position — and sedated under general anesthesia. The surgeon
`then:
`
`0 Using a flouroscope, a type of real-time x-ray machine used in the operating room, ensures
`proper positioning of the vertebra(e) to be treated.
`- Makes a small incision in the skin in the patient's side, over the midsection of the disc for a
`single-level fusion or over the intervening vertebral body for a multi-level fusion.
`- Using flouroscopic guidance, inserts a series of tubular dilators through the soft. tissues and
`fibers of the psoas muscle to create a tiny "tunnel" through which the surgeon may view the
`spine and perform surgery. During this step, a neuromonitoring device such as the NIM-
`Eclipse® System may be used to identify the location of and protect spinal nerve roots.
`- Through the tubular "portal", your surgeon:
`0 Removes all or part of the affected disc (discectomy)
`0 Prepares the bone surfaces of the adjacent vertebrae for fusion
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`http ://www.back. com/treatment-surgical-direct.html
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`CONFIDENTIAL
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`0 Inserts a interbody device and bone graft into the disc space to promote fusion
`0 Removes the tubular portal and closes the incision.
`0 Places pedicle screws and rods in the patient's back using the minimally invasive E
`HORIZON® SEXTANT® System. This instrumentation is intended to provide
`additional stabilization While the bone heals or "fuses."
`
`The NIM-Eclipse® System is manufactured by Axon Systems and distributed by Medtronic.
`
`1 Isaacs. Minimally invasive microendoscopy—assisted transforaminal lumbar interbody fusion. J. Neurosurg: Spine. 3:98-
`l05, 2005.
`
`2 Park, Won Ha. Comparison of one—level posterior lumbar interbody fusion performed with a minim ally invasive approach
`or a traditional open approach. SPTNE 32(5):537—543, 2007.
`
`It is important that you discuss the potential risks, complications and benefits of Direct Lateral
`interbody fusion With your doctor prior to receiving treatment, and that you rely on your doctor's
`judgment. Only your doctor can determine Whether you are a suitable candidate for this treatment.
`
`The materials on this Web site are for your general educational information only. Information you
`read on this Web site cannot replace the relationship that you have With your health care
`professional. We do not practice medicine or provide medical services or advice as a part of this Web
`site. You should always talk to your health care professional for diagnosis and treatment.
`
`Treatment Options
`
`Non-Surgical Options:
`
`- Acupuncture
`- Chiropractic Care
`- Epidural Steroid Injections
`
`- Family Practitioners
`- Medications
`
`- Physic-al Therapy
`
`Surgical Options:
`
`- Minimally Invasive Discectomy
`° Minimally" Invasive Laminotomy/Discectomy
`
`- Anterior Lumbar Interbody Fusion (ALIF)
`- Direct Lateral Interbody Fusion (DLIF)
`- Posterior Lumbar Interbody Fusion g PLIF)
`- Transforaminal Lumbar Interbody Fusion (TLIF)
`
`Related Links:
`
`' Ane.sthesia
`
`- Operating Room Line-up
`- After Surgery
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`http ://wWw.back. com/treatment-surgical-direct.html
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`CONFIDENTIAL
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`7/12/2013
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`- Read_Patient Stories
`- LessInvasive,Spine.con’1
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`Have more questions? Visit our Web sites for answers to all your back and neck problems.
`1 11
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`- Published: February 04, 2010
`- Updated: February 04, 2010
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