PLAINTIFF’S
`EXHIBIT
`
`CASE
`NO.
`
`08CV 01512
`
`EXHIBIT
`
`NO. PX1699
`
`'-U§'E?Y!?~$1VE”
`
`* M.r7v:v.1«:>{;;}r"
`
`L
`
`PX1699-0001
`PX1599'°°°1
`
`MSD 1141
`|PR2013—00506
`|PR2013—00508
`
`N0000029
`NOOOOO29
`
`PX1699
`
`

`
`Preface
`
`MaXcesse Ill Access System
`
`XLIF• Instruments
`
`Anterior/lateral General Instruments
`
`NeuroVision• JJB System
`
`Presurgical Preparation
`
`- Equipment Requirements
`
`- Surgical Considerations
`
`XLIF Surgical Technique
`
`- Patient Positioning & Operating Room Setup
`
`-Anatomic landmark Identification & Initial Incisions
`
`- Retroperitoneal Access
`
`- Retroperitoneal Approach
`
`- Transpsoas Approach
`
`- NeuroVision EMG Monitoring/Twitch Test
`
`-Access
`
`- Annulotomy & Disc Space Preparation
`
`- Implant Sizing & Placement
`
`- XLP~ Plate
`
`- Closure
`
`- Catalog
`
`2
`
`7
`
`8
`
`10
`
`11
`
`11
`
`11
`
`12
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`19
`
`24
`
`25
`
`26
`
`27
`
`28
`
`PX1699-0002
`
`N0000030
`
`

`
`luiz Pimenta . M.D .. Ph .D.
`
`Until now, widespread acceptance of minimally invasive techniques has evaded spine surgery. One reason for this was the inherent difficulty new
`technologies (e.g., endoscopes, optical trocars, CO,) typically introduced while attempting to achieve the same surgical objectives as conventional
`surgery. The XLI r' surg1cal technique is different, however, because it incorporates two systems, described below, that help to avoid these obstacles
`while enabling safe and reproducible minimally disruptive spine surgery.
`
`The MaXcess® System provides maximum surgical access while minimizing the soft tissue disruption that often occurs during open surgery. The
`MaXcess System allows the fundamentals of conventional surgical techniques to be achieved, while eliminating the unfamiliar requirements of
`operating coaxially through tubular portals. Additionally, since there are no adjunctive visualization tools (e.g., endoscope, monitor), the MaXcess
`System enables direct illuminated visualization of the patient's anatomy through conventional methods.
`
`The NeuroVision® JJB System is another important technology that enables safety and reproducibility during minimally disruptive techniques. This
`system is the only surgeon-driven technology that provides dynamic, discrete information on nerve location and cond1tion. The XLIF technique
`described in this guide utilizes a direct lateral, retroperitoneal, transpsoas approach to access the intervertebral disc. NeuroVision is used to enable
`a safe trajectory past the nerves in the psoas muscle by communicating nerve proximity and directional information. This enables the surgeon to
`locate and avoid the lumbar plexus while accessing the disc. NeuroVision is the only nerve avoidance system that has demonstrated safety and
`reproducibility during a lateral trans psoas technique.
`
`XLIF adoption has grown significantly since its introduction. Initially, the XLIF technique was used to address mainly s1ngle-level degenerative conditions
`in the lumbar spine. Since then, the 1ndicat1ons have evolved and expanded. Today it is used routinely as a minimally disruptive solution to address
`many degenerative, deformity, and other conditions that require anterior column support and/or reconstruction.
`
`As we continue to evolve spine surgery and decrease patient morbidity, it is imperative that the techniques do not undermine the surgical
`fundamentals that have served us well. The XLIF technique satisfies this requirement and should be considered as one of the many viable treatment
`options available to the spine surgeon.
`
`Obrigado,
`
`Luiz Pi menta, M.D., Ph.D.
`Hospital Santa Rita
`Sao Paulo, Brazil
`
`PX1699-0003
`
`N0000031
`
`

`
`MAXCESSZ ||| ACCESS SYSTEM
`
`I
`
`MAXIMUM ACCESS. MINIMAL DISRUPTION:"
`
`2
`
`PX1699-0004
`PX1699-0004
`
`N0000032
`NOOOOO32
`
`

`
`MAXCESS; ||| ACCESS SYSTEM
`
`3
`3
`
`N0000033
`NOOOOO33
`
`PX1699-0005
`PX1699-0005
`
`

`
`INSTRUMENTS
`
`ACCESS DRIVER BODY
`
`ACCESS DRIVER HANDLES
`
`4TH BLADE ATTACHMENT
`
`BLADES - so. 60. 10. aomm
`
`BLADES - 90, 100. 110. 110. no. 140 15Dmm
`
`BLADE ROTATION WRENCH
`
`BLADE ROTATION SPREADER
`
`4
`
`HEX DRIVER - 131311
`
`PX1699-0006
`
`N0000034
`
`

`
`INSTRUMENTS (CONT.)
`
`D I LA TORS - NV 6, 9, 11mm (NeuroVISIOn® Compatible)
`
`DILATORS- 6 9. t1mm
`
`INITIAL DILATOR HOLDER
`
`0
`
`00
`
`70
`
`0
`
`0
`
`0
`
`FLUORO MODULATOR
`
`LIGHT CABLE ADAPTERS- IACMI OLYMPUS STORZ)
`
`PX1699-0007
`
`N0000035
`
`

`
`MAXCESS IH ACCESS SYSTEM
`
`INSTRUMENTS (CONT.)
`INSTRUMENTS (CONT.)
`
`BAYUNETTED SHIM INSERTER
`BAYONETTED SHIM INSERTER
`
`SHIM TAMPIRETRIEVAL T[][]L
`
`ARTICULATING ARM TRAY
`
`ARTICULATING ARM
`
`BEDRAIL CLAMP
`BEDRAIL CLAMP
`
`D I S P 0 S A B L E S
`DISPOSABLES
`DISPUSABLE KIT (STERILE)
`DISPOSABLE KIT (STERILE)
`
`DISPUSABLE SHIM KIT (STERILE)
`DISPOSABLE SHIM KIT (STERILE)
`
`LIGHT CABLE (STERILE)
`LIGHT CABLE (STERILE)
`
`6
`
`ANNULUTUMY KNIFE
`
`PX1699-0008
`PX1699-0008
`
`K-WIRE-1135"»
`
`N0000036
`NOOOOO36
`
`

`
`XLIF DISTRACTOR
`
`IMPLANT TAMP
`
`•
`
`t)NUVAS ·~ w
`
`7
`
`N0000037
`
`PX1699-0009
`
`

`
`ANTERIUR/LATERAL GENERAL|NSTRUMENTS(TRAY UNE)
`
`KERRISUN RUNGEURS - 3,5n1m
`
`PITUITARY RUNGEURS - MEDIUM, LARGE
`
`BIPULAR FURCEPS - ANGLED, STRAIGHT
`BIPOLAR FORCEPS- ANGLED , STRAIGHT
`
`BIPOLAR FURCEPS CABLE
`BIPOLAR FORCEPS CABLE
`
`EHISELS - 7. 12mm STRAIGHT
`
`NERVE RETRAIITUR
`
`SUCTION NERVE RETRAETUR
`
`PENFIELD — PUSH, PULL LEINIS
`
`SUCTION -1l]FR,1ZFRLl]Nl3
`
`HUDSON ADAPTER
`HUDSON ADAPTER
`
`SLAP HAMMER
`SLAP HAMMER
`
`T—HANDLE
`T-HANDLE
`
`
`
`PX1699-001 0
`PX1699-0010
`
`N0000038
`NOOOOO38
`
`8
`
`

`
`ANTERIUR/LATERAL GENERAL|NSTRUMENTS(TRAY TWO)
`
`[2 U RETT ES - STRAIGHT, up, nuwu; SMALL, MEDIUM, LARGE
`
`DISC CUTTER - a mu llnnm
`
`COBB ELEVATOR - STRAIGHT nnwu; SMALL [ARISE
`
`EX
`
`9
`9
`
`N0000039
`NOCJOOO39
`
`PX1699-0011
`PX1699-0011
`
`

`
`NEUROVBION JJB SYSTEM
`
`CONTROL UNIT
`CONTROL UNIT
`
`PATIENT MODULE
`PATIENT MODULE
`
`STIMULATION HANDPIECE
`STIMULATION HANDPIECE
`
`NEUROVISION ' JJB SYSTEM DISPOSABLES
`
`REFERENCE. ANODE. AND RECORDING SURFACE ELECTRODES
`
`PEDICLE PROBE ISTERILEI
`PEDICLE PROBE (STERILE)
`
`REFERENCE, ANODE, AND RECORDING NEEDLE ELECTRODES ISTERILEI
`REFERENCE. ANODE. AND RECORDING NEEDLE ELECTRODES (STERILE)
`
`EMG HARNESS
`
`I0
`10
`
`PX1699-0012
`PX1699-0012
`
`N0000040
`NO0OOO4O
`
`

`
`EQUIPMENT REQUIREMENTS:
`To successfully complete this technique, the following instruments are required:
`
`• Radiolucent Bendable Surgical Table
`• C-Arm
`• Light Source
`• MaXcess ®Ill Access System
`• XLIF ® Instruments
`• Anterior/Lateral General Instruments
`• NeuroVision• JJB System
`• MaXcess Articulating Arm Tray
`• MaXcess Disposable Kit
`• NeuroVision JJ B System XLI F Disposables Module
`
`SURGICAL CONSIDERATIONS:
`The XLIF procedure enables access to the spine via a direct lateral, retroperitoneal approach. The anatomic landmarks the surgeon should
`consider when preparing for this technique are: the iliac crest, the 12th rib, and the lateral border of the erector spinae musdes.
`
`Two small incisions will be made during this procedure. The surgeon will use the first incision, located near the lateral border of the erector
`spinae muscles, to access the retroperitoneal space and safely guide the initial NeuroVision Dilator to the psoas muscle. The second incision,
`located in a direct lateral position, will be used to place the Dilators and retractor, and will provide disc space access. This two-incision technique
`was specifically developed to offer simple and efficient access to the spine, while minimizing the potential for peritoneal injury.
`
`RETROPERITONEAL ACCESS
`Alternate blunt scissor and finger dissection is used to safely enter the retroperitoneal space. Once the index finger is inside the space, a gentle
`sweeping motion is used to release the peritoneum anteriorly and create a safe space through which the Dilators and retractor will pass. The
`initial NeuroVision Dilator will first pass through the oblique muscle layers and meet the index finger just inside the retroperitoneal space. The
`index finger will then escort the Dilator safely past the peritoneum down to the surface of the psoas muscle.
`
`TRANSPSOAS ACCESS
`Once the initial NeuroVision Dilator is on the surface of the psoas muscle, NeuroVision is connected to the Dilator. As the Dilator is advanced
`through the psoas, the surgeon uses NeuroVision to avoid the nerves of the lumbar plexus. A direct lateral traJectory targeting approximately
`the middle of the disc minimizes the chance of encountering a nerve and ensures that the anterior vessels remain well anterior to the
`access corridor. Once docked on the sp1ne, the Dilator is affixed to the disc with a K-Wire and subsequent dilation and muscle-splitting
`retraction establish the operative corridor.
`
`11
`
`N0000041
`
`PX1699-0013
`
`

`
`STEP 1:
`PATIENT POSITIONING & O.R. SETUP
`The patient is placed on a bendable surgical table in a
`direct lateral decubitus (90°) position so that the iliac
`crest is directly over the table break. The patient is then
`secured with tape at the following locations (Fig. 1):
`
`A) Just below the il1ac crest
`B) Over the thoracic region
`C) From the iliac crest to the knee, then secured to
`the table
`D) From the table to the knee, past the ankle, then
`secured to the table
`
`This configuration ensures that the pelvis tilts away from
`the spine, allowing access to all lumbar levels, particularly
`L4-L5.
`
`Using fluoroscopy to verify location, the surgical table
`should be flexed to increase the distance between the
`iliac crest and the ribs in order to gain direct access to
`the disc (Fig. 2).
`
`Once the patient is secured, the table should be adjusted
`so that the C-Arm provides true AP images when at O? and
`true lateral images when at 90° (Figs. 3, 4).
`
`Table should be adjusted independently when accessing
`each level in order to maintain this relationship.
`
`The NeuroVision" control unit should be placed opposite
`the surgeon to enable an unobstructed view (Fig. 5).
`
`DISTINCT ENDPLATES
`
`DISTINCT ENDPLATES
`
`SPINOUS PROCESS
`CENTERED BETVVEEN
`PEDICLES
`
`(Fig. 4)
`
`FLUORO
`MONITOR
`
`'
`
`12
`
`PX1699-0014
`
`A
`
`~ )
`=
`~~
`
`B
`
`~ ~
`
`(Ag. I)
`
`ANESTHESIA
`
`(Fig. 5)
`
`N0000042
`
`

`
`ANTERIOR
`
`STEP 2:
`ANATOMIC LANDMARK IDENTIFICATION &
`INITIAL INCISIONS
`Following aseptic preparation, the disc space is localized
`using lateral fluoroscopy. This is accomplished by
`crossing two K-Wires over the pathologic level centered
`over the indicated disc space (A"g. 6) A mark on the skin
`is made at the intersection of the K-Wires to serve as the
`location of the skin incision for the operative corridor.
`
`Another mark is made on the skin at a posterolateral
`location between the ilium and the rib cage. Typically,
`this is a finger length's distance from the lateral incision
`and just lateral to the erector spinae muscles (Fig. 7). It
`is through this incision that the retroperitoneal space
`will be accessed via blunt scissor and finger dissection.
`
`POSTEROLATERAL
`INCISION
`
`LATE
`
`I
`/
`
`DIRECT LATERAL
`INCISION
`
`ANTERIOR
`
`a::
`0
`
`ii2 w ...
`
`~
`
`a::
`Q
`
`a:: w ...
`
`~
`
`a::
`0
`ii2 w
`a.
`::I
`<II
`
`a::
`Q
`a:: w
`a.
`::I
`<II
`
`a::
`0
`ii2 w
`a.
`::I
`<II
`
`POSTERIOR
`
`(Fig. 7)
`
`POSTERIOR
`
`(Fig. 6)
`
`13
`
`N0000043
`
`PX1699-0015
`
`

`
`STEP 3:
`RETROPERITONEAL ACCESS
`Through th e posterolateral incision, the subcutan eous
`tissue layers are dissected using alternating blunt scissor
`and finger dissection (Fig. 8). The blunt scisso rs are used
`to carefully spread the muscle fibers, while subsequent
`finger advancement enables the surgeon to determine
`whether resistance by the muscl e tissue exists. Typically,
`a loss of resistance by the muscle tissue indicates that
`the retroperitoneal space has been reached. Care should
`be taken to avoid abrupt advancement, which could
`cause perforation ofthe peritoneum.
`
`Once inside the retroperitoneal space, the index finger
`is used to create space and sweep the peritoneum
`anteriorly (Fig. 9). When the peritoneum is released,
`the finger is th en used to palpate the psoas muscle, or
`anterior tip of th e transverse process (Fig. 10).
`
`(Fig. 8)
`
`14
`
`PX1699-0016
`
`N0000044
`
`

`
`STEP 4:
`RETROPERITONEAL APPROACH
`identified, the
`Once the psoas muscle location is
`index finger is swept up to the inside abdominal wall
`underneath the direct lateral skin mark (Fig. II). This
`step ensures that a safe pathway exists between the
`abdominal wall and the psoas muscle.
`
`An incision is made at this location (Fig. 12) and the initial
`NeuroVision@ Dilator (black) is introduced (Fig. 13).
`
`The index finger that is inside the retroperitoneal space is
`then used to escort the initial Dilator safely down to the
`psoas muscle (Fig. 14).
`
`DIRECT LATERAL
`INCISION
`
`POSTEROLATERAL
`INCISION
`
`(Fig. 12)
`
`15
`
`N0000045
`
`PX1699-0017
`
`

`
`STEP 5:
`TRANS PSOAS APPROACH
`initial
`Upon reaching the psoas muscle with the
`NeuroVision • Dilator, the location is verified with a
`lateral fluoro image. The ideal location is approximately
`at the center (or just postenor to center) of the disc
`space (Fig. 15).
`
`The Large Dynamic Stimulation Clip is attached to
`the initial Dilator and NeuroVision is activated
`in
`Detection mode (see opposite page for more detail).
`The fibers of the psoas muscle are then split using
`blunt dissection with the initial Dilator. It is slowly
`advanced while NeuroVision
`is active in Detection
`mode (Fig. 16). If the Dilator is determined to be too
`close to a nerve, the Dilator is slowly rotated 360° to
`determine the location of the nerve. (A line on the
`proximal end of the Dilator corresponds to an electrode
`on the side of the distal tip. NeuroVision will indicate
`a higher value when the electrode faces away from
`the nerve.) The Dilator is removed from the psoas.
`Then the Dilator is moved a couple of millimeters in a
`different direction, and a new path through the psoas
`muscle is attempted.
`
`(Fig. 15)
`
`(Fig. 16)
`
`16
`
`PX1699-0018
`
`N0000046
`
`

`
`LINE ON DILATOR
`IDENTIFIES ELECTRODE
`PLACEMENT LOCATION
`
`NEUROVISION~ EMG MONITORING
`Attach the Large Dynamic Stimulation Clip to the
`proximal end of the NeuroVision Dilator as shown
`(Fig. A). The Dilators are insulated to minimize current
`shunting while an isolated electrode at the distal tip acts
`as the stimulation source (Fig. B).
`
`The descending nerves of the lumbar plexus tend to
`lie in the posterior one-third of the psoas muscle. The
`NeuroVision System assists with safe passage past these
`nerves andjor confirmation of their posterior location
`via evoked-EMG monitoring. In Detection mode, the
`NeuroVision System will continuously search
`for
`the stimulus threshold that elicits an EMG response
`on the myotomes monitored and audibly and visually
`reports the thresholds (Fig. C).
`
`As the Dilator is advanced through the psoas muscle, the
`stimulus necessary to elicit an EMG response will vary
`with distance from the nerve- i.e., the closer the stimulus
`source is to the nerve, the less stimulus intensity will be
`required to elicit a response, and the lower the resulting
`threshold will be, providing an indication of relative
`proximity of the Dilator to the nerve. Studies have
`shown thatthresholds of SmA or less may indicate direct
`contact with nerve tissue. Experience has suggested that
`threshold values greater than lOrnA indicate a distance
`that allows for both continued nerve safety and ample
`working space*
`
`NEUROVISION• TWITCH TEST
`The Twitch Test is used to determine the level of muscle
`relaxants present in the patient, specifically in the
`myotomes to be monitored by EMG. The Twitch Test can
`be performed either in peripheral or direct stimulation
`mode. The system will stimulate up to four pulses and
`display results as a percentage and bar graph (Fig. D).
`Greater than 75% motor function is required to ensure
`accurate EMG readings*
`
`*For more information, please refer to the NeuroVision JJB Quick Reference Manual.
`
`PX1699-0019
`
`(Fig. D)
`
`17
`
`N0000047
`
`

`
`STEP 5:
`TRANSPSOAS APPROACH (CONT.)
`Once the initial Dilator is docked on the disc, fluoroscopy
`should be used to confirm position.
`
`image should confirm that the Dilator is
`A lateral
`approximately centered on, and parallel with, the
`disc (Fig. 17). If the Dilator is not at the optimal
`position, NeuroVision• may be activated and the Dilator's
`position adJusted.
`
`A cross-table AP image should confirm that the Dilator
`is in the plane of, and flush with, the disc space (Fig. 18).
`
`Following confirmation of position, a K-Wire is introduced
`about halfway into the disc space to secure position
`(Fig. 19). Depth markings on the Dilator indicate the size
`of the appropriate-length Blades to be attached to the
`MaXcess• Access Driver.
`
`(Rg. 17)
`
`(Rg. 18)
`
`18
`
`PX1699-0020
`
`N0000048
`
`

`
`STEP 5:
`TRANSPSOAS APPROACH (CONT.)
`The next two NeuroVision• Dilators (magenta, blu e)
`are subseq uently introduced over the initial Dilator
`using a twisting motion. Neu roVision is used as with the
`previous Dilator to determine nerve proximity.
`
`The lines of the center arm should be aligned with the
`lines on the left (L) an d right (R) arms and the retractor
`closed (Fig. 20) . The center (C) Blade shoul d be loaded
`first and the set-screw tightened. The Land R Blad es can
`then be loaded and the set-screws tightened (Fig. 21).
`
`STEP 6:
`ACCESS
`The Access Driver is introduced over the third Dilator
`with the handles pointing posteriorly. The NeuroVision
`Dynamic Stimulation Clip may be attached to the post
`on top of the center Blade to stimulate an electrode
`on the distal end of the Blade (Fig. 22). Cross-tabl e AP
`fluoroscopy is used to confirm the correct pos~ion ofthe
`Access Driver Blades on the spine, and to ensure that the
`Blades are parallel with the disc space (Fig. 23).
`
`(Fig. 21)
`
`(Fig. 20)
`
`PX1699-0021
`
`(Fig. 23)
`
`19
`
`N0000049
`
`

`
`STEP 6:
`ACCESS (CONT.)
`The Articulating Arm bedrail attachment should
`be attached to the bedrail of the table (Fig 24). The
`Articulating Arm post is passed through the bedrail
`attachment, adjusted to the desired height, and locked
`into position by tightening th e handle on the bedrail
`attachment (Fig. 25). The oppos ite end ofthe Articulating
`Arm is attached to the Access Driver (Fig. 26).
`
`The Articulating Arm attachment point closer to the
`exposure is used most commonly. This fixes the center
`Blade relative to the table and results in the right and
`left Blades moving anteriorly when opened to minimize
`Blade pressure at the posterior portion of the psoas
`muscle, where the majority of the nerves are located
`(Fig. 26a). The Articulating Arm attachment point closer
`to the handles of the retractor affixes the Access Driver
`Body to the table and results in the center Blade moving
`posteriorly when opened (Fig. 26b). Care must be
`taken to avoid compression of neural elements behind
`the center Blade against the transverse processes in
`this configuration.
`
`SUPERIOR
`
`a::
`2
`a:: w
`1-z
`c:r::
`
`20
`
`INFERIOR
`
`(Fig 26)
`
`PX1699-0022
`
`RIGHT AND LEFT BLADES
`MOVE ANTERIORLY
`
`(Fig 26a)
`
`CENTER BLADE
`MOVES POSTERIORLY
`
`ATTACHMENT CLOSER
`TO HANDLES
`
`(Fig. 26b)
`
`N0000050
`
`

`
`STEP 6:
`ACCESS (CONT.)
`While holding the Access Driver in position using
`downward pressure, turn the knob on the Articulating
`Arm clockwise to lock into place (Fig. 27).
`
`To lock the Access Driver in place, the knob on the
`Articulating Arm is turned clockwise while holding the
`Access Driver in position using downward pressure.
`
`Blades are expanded approximately three "clicks" in a
`superior/inferior direction by squeezing the handles on
`the Access Driver (Fig. 28).
`
`Anterior/Posterior exposure is achieved by turning the
`knobs on the sides of the Access Driver in the direction
`of the arrows (Fig. 29).
`
`(Fig. 27)
`
`INFERIOR
`
`(Fig 28)
`
`(Fig. 29)
`
`21
`
`N0000051
`
`PX1699-0023
`
`

`
`STEP 6:
`ACCESS (CONT.)
`The single end of the bifurcated Light Cable and
`the appropriate I ight source connector are passed
`off the sterile field, where it is then attached to a light
`source. The two remaining ends of the Light Cable
`are placed about halfway down the left and right
`Blades of the Access Driver and bent flush to the surface
`of the Access Driver (Fig. 30).
`
`Proper anterior/posterior pos~ion is verified using lateral
`fluoroscopy.
`
`Any residual tissue at the bottom of the exposure is
`thoroughly explored, using the NeuroVision" Pedicle
`Probe to confirm that nerves are not within the
`exposure.
`
`Shims are available in various sizes to either effectively
`widen or lengthen the Blades to keep tissue out of the
`exposure. An lntradiscal Shim may be placed into the
`disc space to further stabilize the retractor (Fig. 3/).
`
`ANTERIOR
`
`POSTERIOR
`
`(Fig. 30)
`
`22
`
`PX1699-0024
`
`N0000052
`
`

`
`STEP 6:
`ACCESS (CONT.)
`Shims can be placed down the Blades. A Penfield,
`Nerve Retractor, or Psoas Retractor ca n be used to tuck
`residual tissue behind the Shims (Figs. 32-36) Bipolar
`electrocautery can be used,
`if necessary, to further
`prepare for disc visualization.
`
`(Fig. 32)
`
`(Fig. 33)
`
`(Fig. 34)
`
`(Fig. 35)
`
`(Fig 36)
`
`23
`
`N0000053
`
`PX1699-0025
`
`

`
`STEP 6:
`ACCESS (CONT.)
`If necessary, either the Blade Rotation Wrenches or
`Blade Rotation Spreader can be used to rotate either one
`or both of the Blades (Figs. 37, 38) . This expands the
`distal part of the exposure and may be helpful to
`preferentially adjust the exposure in either direction (e.g.,
`inferiorly at L4-L5 under the iliac crest) to gain optimal
`access to the disc space. Care should be taken to avoid
`expanding the Blades to the mid-vertebral body to
`minimize psoas trauma and risk of segmental vessel
`injury. Exposure should be only as wide as the disc
`space. Wider exposure unnecessarily increases psoas
`muscle trauma and risk of postoperative discomfort.
`Blade locks will automatically slide forward to secure
`Blade position.
`
`STEP 7:
`ANNULOTOMY & DISC SPACE PREPARATION
`An annulotomy approximately lBmm in length (anterior
`to posterior) is created with the Annulotomy Knife. The
`Cobb Elevator is passed along both endplates and
`completely through the contralateral annulus (Fig. 39).
`This step is critical to facilitate distraction of the disc
`space, achieve proper coronal alignment, and place
`a large implant that spans the ring apophysis.
`
`Pituitaries, Curettes, Disc Cutters, Endplate Scrapers,
`and other disc preparation instruments can be used to
`thoroughly evacuate the disc and prepare the end plates
`for fusion (Fig. 40).
`
`(Fig. 39)
`
`(Fig. 40)
`
`N0000054
`
`24
`
`PX1699-0026
`
`

`
`STEP 8:
`IMPLANT SIZING & PLACEMENT
`The XLI Fe Distractor and Paddle Sizers are used to
`distract the disc space and gauge the appropriately
`sized Trial. The selected Trial is placed onto th e Inserter
`and the thumb-wheel lock is tightened to secure the
`Trial (Fig. 41). Under AP fluoroscopy, the Trial is gently
`impacted into the dis c space until centered (Fig. 42).
`Proper anterior/posterior pos ition is verifi ed using lateral
`fluo roscopy.
`
`If satisfied with placement and fit of the Trial, it can be
`removed from the disc space. The Slap Hammer can be
`used, if necessary, to facilitate Trial removal.
`
`The corresponding implant is selected, filled with graft
`material, and attached to Inserter. The implant
`is
`gen~y impacted into the disc space while monitoring
`placement under AP fluoroscopy and NeuroVision•
`Free Run EMG. Ideal placement of implant is centered
`across the disc space from a medial/lateral perspective,
`and between the anterior third and middle third of
`the disc space from an anterior/posterior perspective
`(Figs. 43, 44).
`
`(Fig. 43)
`
`PX1699-0027
`
`25
`
`N0000055
`
`

`
`STEP 9:
`XLP'" PLATE
`Pilot hole preparation and bolt insertion are performed
`through XLP Guides. The appropriate length guide is
`introduced through the XLIF• exposure and centered
`over the disc space. With the guide properly positioned,
`the spikes are inserted into both vertebral bodies to
`secure them into place (Fig. 45).
`
`instruments are available in the XLP set to
`Several
`create pilot holes, including taps, drills, and avvs. The
`selected instrument(s) should be inserted through the
`XLP Guide and a pilot hole created to the desired depth
`and trajectory (Fig. 46).
`
`(Rg. 45)
`
`26
`
`PX1699-0028
`
`(Fig. 46)
`
`N0000056
`
`

`
`STEP 9:
`XLP'" PLATE (CONT.)
`With a pilot hole prepared, the appropriate length bolt
`is introduced through the guide barrel and inserted to
`appropriate depth. Bolt insertion is repeated on the
`adjacent level.
`
`With both bolts in place, the appropriate length plate
`is inserted over both bolts, ensuring the heads are
`properly exposed above the plate for lock nut insertion.
`After verification that the plate is fully seated, lock nuts
`are inserted onto both bolts.
`
`Final tightening on both lock nuts (Fig. 47) completes
`the procedure (Fig. 48).
`
`Refer to the XLP Surgical Technique Guide for more
`detailed information on the XLP eXtreme Lateral Plating
`System.
`
`STEP 10:
`CLOSURE
`Once the procedure is completed, the Access Driver is
`removed while using direct visualization to verify the
`absence of significant bleeding in the disc space or
`psoas muscle.
`
`The skin is closed using standard subcuticular suture.
`
`Supplemental instrumentation is added as warranted.
`
`(Fig. 47)
`
`27
`
`N0000057
`
`(Fig 48)
`
`PX1699-0029
`
`

`
`SYSTEMS
`
`MaXcess Ill Access System
`MaXcess Articulating Arm Tray
`MaXcess Disposables
`XLIF Instruments
`Anterior/Lateral General Instruments (Tray One)
`Anterior/Lateral General Instruments (Tray Two)
`NeuroVision• JJB System
`NeuroVision JJB System Disposables
`
`MAXCESS Ill ACCESS SYSTEM
`
`MAXCESS Ill ACCESS SYSTEM
`
`DESCRIPTION
`
`Access Driver Body
`Access Driver Handle - Right
`Access Driver Handle - Left
`Hex Driver (3/32")
`50mm Left Blade
`60mm Left Blade
`70mm Left Blade
`80mm Left Blade
`90mm Left Blade
`100mm Left Blade
`110mm Left Blade
`120mm Left Blade
`130mm Left Blade
`140mm Left Blade
`150mm Left Blade
`50mm Right Blade
`60mm Right Blade
`70mm Right Blade
`80mm Right Blade
`90mm Right Blade
`1 oomm Right Blade
`11 Omm Right Blade
`120mm Right Blade
`130mm Right Blade
`140mm Right Blade
`150mm Right Blade
`50mm Center Blade
`60mm Center Blade
`70mm Center Blade
`80mm Center Blade
`
`CATALOG#
`
`DESCRIPTION
`
`CATALOG#
`
`3200309
`3200107
`3200108
`3200016
`3231050
`3231060
`3231070
`3231080
`3231090
`3231100
`3231110
`3231120
`3231130
`3231140
`3231150
`3232050
`3232060
`3232070
`3232080
`3232090
`3232100
`3232110
`3232120
`3232130
`3232140
`3232150
`3213050
`3213060
`3213070
`3213080
`
`90mm Center Blade
`1 oomm Center Blade
`110mm Center Blade
`120mm Center Blade
`130mm Center Blade
`140mm Center Blade
`150mm Center Blade
`Dilator - 6mm
`Dilator - 9mm
`Dilator - 12mm
`Dilator - 6mm, NV
`Dilator - 9mm, NV
`Dilator - 12mm, NV
`Initial Dilator Holder
`K-Wire (13.5")
`4th Blade Attachment
`Blade Rotation Wrench
`Blade Rotation Spreader
`Fluoro Modulator
`Shim Tamp/Retrieval Tool
`Bayonetted Shim Inserter
`Hex Key (3/32")
`Light Cable Adapter, ACMI
`Light Cable Adapter, Storz
`Light Cable Adapter, Olympus
`MaXcess Set-Screw (#10·31 x .188"')
`MaXcess Set-Screw (#I0-31 x .150")
`MaXcess Center Blade Set-Screw
`MaXcess Ill Access System Sterilization Case
`
`3213090
`3213100
`3213110
`3213120
`3213130
`3213140
`3213150
`3202006
`3202009
`3202012
`3230131
`3230132
`3230133
`3230130
`3230101
`3220200
`3220050
`3220052
`3220131
`3200051
`3200215
`3200042
`3200045
`3200046
`3200047
`3230055
`3230056
`3230057
`3230020
`
`MAXCESS ARTICULATING ARM TRAY
`
`MAXCESS DISPOSABLES
`
`DESCRIPTION
`
`Articulating Arm
`Articulating Arm Bed rail Clamp
`Articulating Arm Sterilization Case
`
`CATALOG#
`
`3220121
`3230122
`3220030
`
`DESCRIPTION
`
`Disposable Kit (Sterile)
`Disposable Shim Kit (Sterile)
`Light Cable (Sterile)
`Annulotomy Knife
`K-Wire (13.5")
`
`CATALOG #
`
`3200060
`3200061
`3200220
`3101055
`3230101
`
`28
`
`PX1699-0030
`
`N0000058
`
`

`
`XLIF"INSTRUMENTS
`
`ANTERIOR/lATERAl GENERAL INSTRUMENTS (TRAY ONE)
`
`DESCRIPTION
`
`CATALOG #
`
`DESCRIPTION
`
`CATALOG #
`
`Hudson T-Handle
`Implant Tamp
`Psoas Retractor - 4mm
`Psoas Retractor - 1 Omm
`Distractor
`Paddle Sizer- 8mm
`Paddle Sizer- 1 Omm
`Paddle Sizer- 12mm
`Paddle Sizer- 14mm
`Paddle Sizer- 16mm
`Paddle Shaver- Smm
`Paddle Shaver- 10mm
`Paddle Shaver- 12mm
`Paddle Shaver- 14mm
`Paddle Shaver- 16mm
`Broach - 6 x 1Bmm
`Broach - 8 x 18mm
`Broach -10 x 18mm
`Broach- 12 x 18mm
`Broach - 14 x 18mm
`Instruments Sterilization Case
`
`5000901
`3300019
`3300023
`3300024
`3300040
`3300608
`3300610
`3300612
`3300614
`3300616
`3300808
`3300810
`3300812
`3300814
`3300816
`5001206
`5001208
`5001210
`5001212
`5001214
`3300130
`
`Bipolar Forceps Cable
`Nerve Retractor - Long
`Suction Nerve Retractor- Long
`Suction - 1 o FR Long
`Suction- 12 FR Long
`Bipolar Forceps -Angled
`Bipolar Forceps - Straight
`Penfield - Long, Push
`Penfield - Long, Pull
`Slap Hammer
`Threaded Hudson Adapter
`Implant Removal Tool
`7mm Chisel - Straight
`12mm Chisel -Straight
`Kerrison Rongeur - 3mm
`Kerrison Rongeur - 5mm
`Pituitary Rongeur- Medium
`Pituitary Rongeur - Large
`ALGI Sterilization Case One
`
`ANTERIOR/lATERAL GENERAl INSTRUMENTS (TRAY TWO)
`
`NEUROVISION" JJB SYSTEM
`
`DESCRIPTION
`
`CATALOG#
`
`DESCRIPTION
`
`3100052
`3300014
`3300015
`3300017
`3300028
`3300012
`3300022
`3300118
`3300218
`5000120
`5001901
`6600171
`6900123
`6900124
`6900133
`6900135
`6900430
`6900431
`6900089
`
`CATALOG#
`
`2011000
`
`8mm Disc Cutter
`1 Omm Disc Cutter
`12mm Disc Cutter
`14mm Disc Cutter
`Cobb Elevator -Straight, Large
`Cobb Elevator -Straight, Small
`Cobb Elevator - Down, Large
`Cobb Elevator - Down, Small
`Straight Curette -Large
`Straight Curette- Medium
`Straight Curette - Small
`Up-Angled Curette- Large
`Up-Angled Curette- Medium
`Up-Angled Curette- Small
`Down-Facing Curette -Large
`Down-Facing Curette -Medium
`Down-Facing Curette - Small
`Endplate Scraper- Push, Large
`End plate Scraper- Pull, Large
`Serrated Rasp
`ALGI Sterilization Case Two
`
`6900151
`6900152
`6900153
`6900154
`6900220
`6900222
`6900221
`6900223
`6900300
`6900310
`6900301
`6900306
`6900305
`6900314
`6900309
`6900308
`6900307
`6900320
`6900321
`6900340
`6900095
`
`NeuroVision JJB System
`Includes:
`Control Unit
`Patient Module
`Stimulation Handpiece
`Handpiece Sterilization Case
`lnStim• Tap Insulator
`Impedance Meter
`Impedance Meter Leads
`NV JJB Quick Reference Manual
`
`NEUROVISION JJB SYSTEM DISPOSABLES
`
`DESCRIPTION
`
`CATALOG#
`
`NeuroVision JJB System XLIF Disposables Module 8010020
`Includes:
`(1) Pedicle Probe (Sterile)
`(1) Large Dynamic Stimulation Clip (Sterile)
`Dual EMG Electrodes
`Twitch Test Stimulation Leads
`EMG Harness Kit
`Patient Preparation Supplies
`
`29
`
`N0000059
`
`PX1699-0031
`
`

`
`!.:J NUVASIVE.
`
`Creative Spine Technology•
`
`To order, please contact your NuVasive Sales Consultant or Customer Service Representative today at:
`4545 Towne Centre Court, San Diego, CA 92121 • phone: 800-475-9131 fax: 800-475-9134
`www.nuvasive.com
`© 2007. NuVasive, Inc. All rights reserved. l:l, NuVasive, Creative Spine Technology, lnStim, MaXcess, NeuroVision, and XLIF are federal~ registered trademarks of NuVasive, Inc.
`MAS, Maximum Access. Minimal Disruption., and XLP are common law trademarks of NuVasive, Inc. Patent(s) pending.
`
`9500138 A.O
`
`N0000060
`
`PX1699-0032