Case 3:18-cv-00347-CAB-MDD Document 253-9 Filed 01/18/20 PageID.22472 Page 1 of 49
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`EXHIBIT 9
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`TO THE DECLARATION OF BRIAN J. NISBET
`IN SUPPORT OF DEFENDANTS’ MOTION
`FOR SUMMARY JUDGMENT OR, IN THE
`ALTERNATIVE, SUMMARY ADJUDICATION
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`

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`NUVA_ATEC0015567
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`I
`~- MAS \ MAXIMUM ACCESS SURGICAL PLATFORM
`
`CONTENTS
`
`Preface
`
`Presurgical Preparation
`
`Equipment Requirements
`
`Surgical Considerations
`
`XLIF .. Surgical Technique
`
`Patient Positioning and O.R. Setup
`
`Anatomic Landmark Identification and Initial Incisions
`
`Retroperitoneal Access
`
`Retroperitoneal Approach
`
`Tran spsoas App roach
`
`XLIF Electrode Installation and Retractor Assembly
`
`Access
`
`Annulotomy and Disc Space Preparation
`
`Implant Sizing
`
`App licatio n-S pecif ic Solutions
`
`Implant Placement
`
`XLI F Decade'" Plate
`
`Removal and Closure
`
`Implant Removal
`
`XLIF Applications
`
`XLIF System
`
`Catalog
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`2
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`2
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`3
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`4
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`4
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`7
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`8
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`9
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`10
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`12
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`14
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`22
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`23
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`24
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`25
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`28
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`30
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`30
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`31
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`33
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`40
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`Fellow Colleagues:
`
`The XLIP~ Procedure was created to be a safer and more reproducible, minimally disruptive procedure that utilizes conventional surgical
`techniques and a seamlessly integrated Maximum Access Surgery (MAS®) platform. With years of experience and thousands of successful
`procedures and system advancements, XLIF applications have expanded from single-level DDD to advanced degenerative spinal pathologies.
`XUF is the first clinically validated lateral approach to the spine, allowing surgeons to accomplish fundamental surgical goals - anterior column
`correction and fusion.
`
`Whereas previous attempts at minimally disruptive spine surgery ( e.g., endoscopes, optical trocars, CO2) typically introduced an inherent
`difficulty in using the new technology, XUF is minimally disruptive while utilizing conventional surgical techniques. Over the years, the XLIF
`procedure and technology have evolved. However, two systems, described below, were designed to help enable safer and more reproducible
`minimally disruptive spine surgery, compared to previous technologies.
`
`The MaXcess® 4 Access system provides maximum surgical access while minimizing the soft tissue disruption that often occurs during open
`surgery. MaXcess 4 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., endoscopes, monitors), the
`MaXcess 4 Access system enables direct, illuminated visualization of the patient's anatomy through conventional methods.
`
`The NVMS® system is another important technology that helps enable more reproducible, minimally disruptive techniques. This system is the
`only surgeon-driven technology that provides dynamic, discrete information on nerve location and condition. The XLIF technique described in
`this guide utilizes a lateral, retroperitoneal, transpsoas approach to access the intervertebral disc. NVMS was designed to enable a safer trajectory
`past the nerves in the psoas muscle by communicating nerve proximity and directionality information. This enables the surgeon to locate and
`avoid the lumbar plexus while accessing the disc NVMS is the only clinically validated nerve avoidance system for reproducibility during a lateral
`transpsoas technique.
`
`XLIF adoption has grown significantly since its introduction. Initially, the XLIF technique was used to address mainly single-level degenerative
`conditions in the lumbar spine. Since then, the applications have evolved and expanded. Today it is used routinely as a minimally disruptive
`solution to address many degenerative spinal pathologies that require anterior column support and/or reconstruction, including deformity.
`
`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 XU F technique satisfies this requirement and should be considered as one of the many viable
`treatment options available to the spine surgeon.
`
`Cordially,
`
`Luiz Pimenta, M.D., Ph.D.
`Hospital Santa Rita
`Sao Paulo, Brazil
`
`NUVA_ATEC0015569
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`( MAS~ MAXIMUM ACCESS SURGICAL PLATFORM
`
`PR ES URG ICAL PR EPA RATION
`
`EQUIPMENT REQUIREMENTS:
`To successfully complete this technique, the following patient positioning supplies, instruments,
`implants, and fixation options are required.
`
`PATIENT POSITIONING:
`• 3-lnch Tape
`• Axillary Roll
`• Foam Padding
`• Radiolucent Bendable Surgical Table
`
`INSTRUMENTS:
`• C-arm
`• Light Source
`• MaXcess" 4 Access System
`• MaXcess 4 Articulating Arm Tray
`• MaXcess 4 Kit
`• MaXcess Fixation Shim Kit (optionaO
`• XLI F"' Instruments
`• Anterior/Lateral General Instruments
`• NVMS"
`• NVMS XLI F Dilator Kit
`• NVMS EMG Module
`
`IMPLANTS:
`• CoRoent" (XL, XL-W, XL-XW, XL-CT, XL-F, XL-FW, XL-T)
`
`LATERAL FIXATION OPTIONS:
`• XLI F Decade"' Lateral Plate
`• StruXure"' Lateral Deformity Fixation System
`
`POSTERIOR FIXATION OPTIONS:
`• Precept"
`• Armada"
`• SpheRx" D BR., I 11
`• SpheRx PPS
`• SpheRx PPS + EXT
`• Radian" Facet Screws
`
`Reference the applicable CoRoent, MaXcess 4, NVMS, XLIF Decade, SpheRx DBR Ill, Armada,
`Precept, Radian, StruXure, and XLIF Decade Lateral Plate Technique Guide(s) or Reference
`Manual(s) and/or Instructions for Use (IFU) for additional important labeling information.
`IFUs can be referenced at www.nuvasive.com/e1FU.
`
`2
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`NUVA_ATEC0015570
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`SURGICAL CONSIDERATIONS:
`The XLIF" procedure enables access to the spine via a 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 muscles.
`
`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 XLIF 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; however, various single(cid:173)
`incision techniques may be used alternatively.
`
`RETROPERITONEAL ACCESS:
`Alternating 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 anterior and create a space through which
`the Dilators and retractor will pass. The initial XLI F 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 XLIF Dilator is on the surface of the psoas muscle, the Dynamic
`Stimulation Clip is connected to the Dilator. As the Dilator is advanced through the
`psoas, the surgeon uses the NVMS" neuromonitoring system to detect and avoid
`the nerves of the lumbar plexus. A direct, lateral trajectory targeting just posterior to
`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 spine, the Dilator is affixed to the disc with a K-wire, and subsequent dilation and
`muscle-splitting retraction establish the operative corridor.
`
`NUVA_ATEC0015571
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`l_ MAS.• MAXIMUM ACCESS SURGICAL PLATFORM
`
`X LI F~ S U R G I CAL TE C H N IOU E
`
`STEP 1:
`
`PATIENT POSITIONING AND O.R. SETUP
`Under A/P fluoro guidance, the patient is placed on
`a radiolucent and bendable surgical table in a direct
`lateral decubitus (90°) position so that the greater
`trochanter is slightly inferior to the table break. The
`patient is then secured with tape at the following
`locations (Fig. 1):
`
`Just below the iliac crest (A)
`
`Over the thoracic region (B)
`
`From the greater trochanter to the knee, and then
`secured to the table with padding placed
`between knees (C)
`
`From the table to the knee, past the ankle, and
`then secured to the table (D)
`
`This configuration ensures that the pelvis tilts away
`from the ipsilateral spine, allowing access to all
`lumbar levels, particularly L4-L5, without interference
`from the iliac crest.
`
`Using fluoroscopy to verify location, flex the surgical
`table (if necessary) to increase the distance between
`the iliac crest and the ribs in order to gain direct
`access to the disc (Fig. 2) and tension the skin.
`
`(Fig. l)
`
`(Fig. 2)
`
`4
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`NUVA_ATEC0015572
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`STEP 1:
`PATIENT POSITIONING AND O.R. SETUP (CONT.)
`
`NVM5" TWITCH TEST
`In order to ensure that accurate EMG readings are obtained
`later in the procedure, it is imperative that a Twitch Test be
`performed once the patient is poshioned and the NVMS
`electrodes are in place (see NVMS Reference Manual for
`details). If the Twitch Test results are unacceptable (Fig. 3),
`anesthesia should be instructed to reverse paralytics and
`muscle relaxants until an acceptable Twhch Test is conducted
`(Fig. 4).
`
`(Fig 3)
`
`(Fig. 4)
`
`5
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`NUVA_ATEC0015573
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`I
`~- MAS \ MAXIMUM ACCESS SURGICAL PLATFORM
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`XLIF~ SURGICAL TECHNIQUE
`
`STEP 1:
`PATIENT POSITIONING AND O.R. SETUP
`(CONT.)
`Once the patient is secured, the table should
`be adjusted so that the C-arm provides true Af P
`images when at 0° (distinct endplates and pedicles
`symmetrical about the spin ous process), and true
`lateral images when at 90° (distinct endplates and
`superimposed pedicles) (Figs. 5, 6).
`
`The table should be adjusted independently when
`accessing each level in order to maintain this
`relationship.
`
`The NVMS" control unit should be placed opposite
`the surgeon to enable an unobstructed view (Fig. 7).
`
`6
`
`(Fig. 5)
`
`(Fig. 6)
`
`ANESTHESIA
`
`(Fig. 7)
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`NUVA_ATEC0015574
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`
`ANTERIOR
`
`(1)
`
`(2)
`
`STEP 2:
`ANATOMIC LANDMARK IDENTIFICATION
`AND INITIAL INCISIONS
`Following standard surgical preparation, the disc
`space is localized using lateral fluoroscopy (Fig. 8).
`
`Use the Targeting Instrument to make longitudinal
`marks on the skin to define the anterior border of
`the vertebral bodies (1), the posterior border of the
`vertebral bodies (2), and the posterior third of the
`disc space (3). Next, a transverse mark, in line with
`the disc space, is made on the skin ( 4). Extending this
`transverse mark serves as a visual reference to both
`surgeon and C-arm operator.
`
`Another mark is made on the skin at a posterolateral
`location that will serve as the location for the skin
`incision for accessing the retroperitoneal space via
`blunt scissor and finger dissection. Typically, this is a
`finger length's distance from the lateral incision and
`just lateral to the erector spinae muscles (Fig 9).
`
`a:
`0
`ii:
`w ....
`z
`
`(3)
`
`(4)
`
`VI
`
`m
`:,a
`
`C: .,,
`0 :,a
`
`(Fig. 8)
`
`POSTERIOR
`
`(Fig. 9)
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`7
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`NUVA_ATEC0015575
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`l_ MAS.• MAXIMUM ACCESS SURGICAL PLATFORM
`
`X LI F" S U R G I CAL TE C H N IOU E
`
`STEP l:
`RETROPERITONEAL ACCESS
`The skin and fascia are incised at the posterolateral
`marking. Through this incision, the muscle layers
`of the external obliques, internal obliques, and
`transverse abdominal are dissected using alternating
`blunt scissor and finger dissection (Fig. 10). Care
`should be taken to preserve the sensory nerves in
`these muscle layers (i.e., electrocautery should be
`avoided). The final fascial layer that will be reached
`is the transversalis fascia, which can be perforated by
`gentle pressure with blunt scissors. Typically, a loss
`of resistance by the fascia and constriction around
`the finger indicates that the retroperitoneal space has
`been reached. Care should be taken to avoid abrupt
`advancement, which could cause perforation of the
`peritoneum.
`
`Once inside the retroperitoneal space, the index
`finger is used to create space and release the
`peritoneum anterior (Fig. 11). When the peritoneum
`is released, the finger is then used to palpate
`the psoas muscle or the anterior surface of the
`transverse process (Fig. 12) for verification of
`position within the retroperitoneal space.
`
`(Fig. 11)
`
`8
`
`(Fig. 12)
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`NUVA_ATEC0015576
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`STEP 4:
`RETROPERITONEAL APPROACH
`Once the retroperitoneal space is identified, the
`index finger is brought up to the inside abdominal
`wall underneath the direct lateral skin mark (Fig. 13).
`Th is step ensures that a pathway exists between the
`abdominal wall and the psoas muscle.
`
`A skin and fascia! incision is made at this location
`(Fig. 14), followed by blunt dissection through muscle
`planes and the transversalis fascia. Next, the initial XLIF
`Dilator (black) is introduced (Fig. 15).
`
`The index finger that is inside the retroperitoneal
`space is then used to escort the initial Dilator down
`to the psoas muscle (Fig. 76).
`
`(Fig. 14)
`
`(Fig. 15)
`
`9
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`NUVA_ATEC0015577
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`l_ MAS MAXIMUM ACCESS SURGICAL PLATFORM
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`.·
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`X LI F~ S U R G I CAL TE C H N IOU E
`
`STEP 5:
`TRANSPSOAS APPROACH
`
`IMPORTANCE OF NEUROMONITORING:
`Neuromonitoring is aitical to the safety and
`reproducibility of any lateral transpsoas approach due
`to the lumbar plexus' positioning within the psoas. The
`motor nerves of the lumbar plexus generally reside
`within the posterior third of the psoas; however, their
`positioning can vary from patient to patient.
`
`The XLIF" Procedure relies on the clinically validated
`dynamic EMC nerve avoidance mode of NVMS"' to
`identify a safer docking position and working area. 1
`
`NVMS offers surgeon-driven, real-time discrete
`thresholds, as well as directionality and relative proximity
`nerve information.
`
`Upon reaching the lateral surface of the psoas muscle
`with the initial XLIF Dilator, verify the location with a
`lateral fluoroscopic image. The ideal docking location is
`the Junction of the posterior third and anterior two-thirds
`of the disc space, or as posterior on the disc space as
`NVMS favorably allows (Fig. 17).
`
`The Dynamic Stimulation Clip is attached to the initial
`Dilator and NVMS is activated in XLIF mode. The initial
`Dilator is then passed medial through the psoas, while
`slowly being rotated 360° to determine the three(cid:173)
`dimensional position of the nerves.2 NVMS will display
`the continually updated threshold stimulation that triggers
`a neural response (Figs. 18-20). A line on the proximal
`end of the Dilator indicates the stimulation direction, and
`if this stimulation is directed away from the nerves, the
`NVMS monitor will display a higher threshold. If alert(cid:173)
`level thresholds indicate an unsafe docking location, the
`Dilator is removed from the psoas and moved to a new
`trajectory, away from the nerves. Lower EMG thresholds
`posterior with higher thresholds anterior, generally
`indicate a safe position. This process is repeated until a
`safe path through the psoas to the spine is identified. For
`more information, refer to the NVMS Quick Reference
`Manual in the help section on the NVMS screen.
`
`lei 1n ng the sa c- worl. s lL ~
`,b:: 5 Arredvndo ~J. Da , ,.ir £, et"
`•'1mo,o/Ne msllrt; 'f} Sa;ne 20JQ l:Uti,-2\>\J.
`·,hn,eh ,i,e, !wdg"~ w~ Pe, e1 m1 D~-,m
`e1~,
`vu11raphv 51 11e
`11 1.,.
`
`'a'! k" d, r~ ~-111 s">hol
`
`10
`
`(Fig. 17)
`
`(Fig. 18)
`
`(Fig. 19)
`
`(Fig. 20)
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`NUVA_ATEC0015578
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`
`STEP 5:
`TRANSPSOAS APPROACH (CONT.)
`Once the initial Dilator is docked on the disc, fluoroscopy
`should be used to confirm proper positioning.
`
`A lateral image should confirm that the Dilator is
`approximately centered on, and parallel with, the disc
`(Fig. 21). If the Dilator is not in the optimal position, it
`may be repositioned with the use of NVMS~
`
`A cross-table A/P image should confirm that the Dilator is
`in the plane of, and flush with, the disc space (Fig. 22).
`
`Following confirmation of the initial Dilator's position,
`introduce a K-wire about halfway into the disc space
`to secure the pos~ion. Laser markings on the K-wire at
`10mm intervals may assist in reaching optimal K-wire
`depth. The depth markings on the Dilator indicate the
`size of the appropriate length Blades to be attached to
`the MaXcess" 4 Access Driver (Fig. 23).
`
`The next two XLI F Dilators (magenta and blue) are
`subsequently introduced over the initial Dilator using
`a twisting motion. NVMS is used as with the previous
`Dilator to determine relative nerve proximity.
`
`(Fig. 21)
`
`(Fig. 22)
`
`(Fig. 23)
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`NUVA_ATEC0015579
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`l_ MAS.• MAXIMUM ACCESS SURGICAL PLATFORM
`
`X LI F~ S U R G I CAL TE C H N IOU E
`
`STEP 6:
`XLIF" ELECTRODE INSTALLATION AND
`RETRACTOR ASSEMBLY
`Once the appropriate Center Blade length has been
`selected, the XLIF Electrode can be installed by sliding
`the Electrode into the Center Blade track, cylindrical
`end first, following the direction of the instructional
`arrow on the back of the Blade (Figs. 24-26).
`
`(Fig. 24)
`
`(Fig. 25)
`
`(Fig. 26)
`
`12
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`NUVA_ATEC0015580
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`
`STEP 6:
`XLIF ELECTRODE INSTALLATION AND
`RETRACTOR ASSEMBLY (CONT.)
`To assemble the Access Driver, align the lines of
`the center arm with the lines on the left (L) and
`right (R) arms with the retractor closed (Fig. 27).
`The Center (C) Blade should be loaded first and
`the set screw tightened.
`
`The L and R Blades can then be loaded and the
`set screws tightened (Fig. 28); the Land R handles
`can be attached to the Access Driver by depressing
`the button and sliding the handles toward the
`retractor body.
`
`(Fig. 27)
`
`(Fig. 28)
`
`13
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`NUVA_ATEC0015581
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`l_ MAS,. MAXIMUM ACCESS SURGICAL PLATFORM
`
`X LI F" S U R G I CAL TE C H N IOU E
`
`STEP 7:
`ACCESS
`The Access Driver is introduced over the third Dilator
`with the handles pointing posterior. The NVMse
`Dynamic Stimulation Clip may be attached to the
`cylindrical lead at the proximal tip of the XLIFe
`Electrode (Fig. 29). The Access Driver is advanced
`through the psoas muscle with slight rotation in
`conjunction with stimulated EMG. Threshold EMG
`readings from the XLIF Electrode provide directionality
`and relative proximity nerve information throughout
`the entire procedure. Constant downward pressure on
`the Access Driver may help mitigate tissue creep.
`Cross-table NP ftuoroscopy is used to confirm the
`correct position of the Access Driver Blades on the
`spine and to ensure that the Blades are parallel with
`the disc space. The Alignment Dots at the distal tips of
`the Land R Blades will align with the bottom corners
`of the C Blade Targeting Window when the retractor
`is in line with the ( -arm, and thus the disc space, and
`parallel with the floor (Fig. 30).
`
`(Fig. 29)
`
`14
`
`(Fig. 30)
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`NUVA_ATEC0015582
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`
`STEP 7:
`ACCESS (CONT.)
`The Articulating Arm bed rail attachment should be
`attached to the bedrail of the table (Fig. 31). The
`Articulating Arm post is passed through the bed rail
`attachment, adjusted to the desired height, and
`locked into position by tightening the handle on
`the bedrail attachment. The opposite end of the
`Articulating Arm is attached to the Access Driver
`(Fig. 32). Maintenance of retractor position may be
`enhanced by maintaining an upward angle of the
`Articulating Arm when attaching it to retractor body.
`
`(Fig. 31)
`
`(Fig. 32)
`
`15
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`NUVA_ATEC0015583
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`l_ MAS.• MAXIMUM ACCESS SURGICAL PLATFORM
`
`X LI F~ S U R G I CAL TE C H N IOU E
`
`STEP 7:
`ACCESS {CONT.)
`The black-coated Articulating Arm attachment point
`is most commonly used for lumbar XLIF" procedures.
`This fixes the C Blade relative to the table and results
`in the Land R Blades moving anterior when opened
`to minimize pressure at the posterior portion of the
`psoas muscle, where the majority of the lumbar
`plexus nerves are located (Fig. 33). The si Iver
`Articulating Arm attachment point is primarily used for
`thoracic applications and affixes the Land R Blades
`to the table, which results in the C Blade moving
`posterior when opened (Fig. 34).
`
`16
`
`(Fig. 33)
`
`NUVA_ATEC0015584
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`
`STEP 7:
`ACCESS (CONT.)
`The Land R Handles of the Access Driver are
`squeezed together to open the Land R Blades
`in the cephalad/caudal direction (Fig. 35). The
`Blades should initially be opened one click.
`
`Initial anterior exposure is achieved by turning
`the knobs on the sides of the Access Driver
`one click in the direction of arrows (Fig. 36).
`
`The single end of the bifurcated Light Cable
`and the appropriate light source connector
`are passed off the sterile field and attached to
`a light source. The two beveled ends of the
`Light Cable are placed about halfway down the
`L and R Blades of the Access Driver and bent
`flush to the surface of the Access Driver.
`
`Proper anterior/posterior position is verified
`using lateral fluoroscopy (Fig. 37).
`
`(Ag. 36)
`
`(Fig. 37)
`
`17
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`•.•
`I
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`~- MAS · .. MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF~ SURGICAL TECHNIQUE
`
`STEP 7:
`ACCESS (CONT.)
`Any residual tissue at the bottom of the exposure is
`thoroughly explored, using the NVMS" Probe to confirm
`that no nerves are within the exposure (Fig. 38).
`
`Shims are available in various sizes to both effectively
`widen and lengthen the Blades to keep tissue out of
`the exposure. A Locking lntradiscal Shim may be placed
`into the disc space to further stabilize the retractor and
`prevent nerves from slipping under the C Blade.
`
`To load the Locking lntradiscal Shim onto the Locking
`Shim Repositioning Tool, align the laser markings and
`slide the Shim onto the Repositioning Tool. The Locking
`Shim Repositioning Tool will click into place when it is
`fully engaged (Fig. 39). The Locking Shim Repositioning
`Tool is used to introduce the Locking lntradiscal Shim
`into the disc space (Fig. 40). To disengage the Locking
`Shim Repositioning Tool from the Locking lntradiscal
`Shim, depress the button (Fig. 4/).
`
`(Fig. 38)
`
`(Fig. 39)
`
`18
`
`(Fig. 40)
`
`(Fig. 41)
`
`NUVA_ATEC0015586
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-9 Filed 01/18/20 PageID.22493 Page 22 of
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`
`STEP 7:
`ACCESS (CONT.)
`
`Additional Shims can optionally be placed
`down the Blades to increase the Blade length
`or width (Fig. 42). A Penfield, Nerve Retractor,
`or Psoas Retractor can be used to tuck residual
`tissue behind the Shims (Fig. 43). Bipolar
`electrocautery can be used, if necessary,
`to further prepare for disc visualization.
`Monopolar electrocautery is best avoided to
`prevent inadvertent nerve injury.
`
`(Fig. 42)
`
`(fig. 43)
`
`19
`
`NUVA_ATEC0015587
`
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`

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`l_ MAS.• MAXIMUM ACCESS SURGICAL PLATFORM
`
`X LI F~ S U R G I CAL TE C H N IOU E
`
`STEP 7:
`ACCESS (CONT.)
`If patient anatomy dictates, the Blade Rotation
`Driver can be used to rotate the Land/or R Blades
`independently (Fig. 44). This will expand the distal
`exposure and may assist in preferentially adjusting
`the exposure cephalad or caudal ( e.g., caudal at
`L4-LS under iliac crest) to gain optimal access to the
`disc space (Fig. 45). Care should be taken to avoid
`expanding the Blades to the mid-vertebral body or
`beyond to minimize psoas trauma and reduce the
`risk of segmental vessel injury. A quarter turn of the
`Blade Rotation Driver corresponds to approximately
`5° of Blade rotation, which can be visualized using
`A/P fluoroscopy.
`
`Open the Access Driver Body in the cephalad/
`caudal direction to create a sufficient exposure
`for disc space preparation (Fig. 46). The nerve
`root retractor or anterior retractors can be used to
`retract tissue to the anterior border of the spine
`(i.e., Anterior Longitudinal Ligament) and can be
`secured using the anterior crossbar (Fig. 47). It
`is recommended that the Anterior Retractor be
`removed during any steps that involve impaction.
`
`T
`
`(Fig. 44)
`
`(Fig. 45)
`
`20
`
`(Fig. 46)
`
`(Fig. 47)
`
`NUVA_ATEC0015588
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-9 Filed 01/18/20 PageID.22495 Page 24 of
` 49
`
`STEP 7:
`ACCESS (CONT.)
`
`FIXATION SHIMS (OPTIONAL)
`Following placement of the Locking I ntradiscal
`Shim and any necessary rotation of the Land/or
`R Blades, MaXcess" Fixation Shims can optionally
`be placed down the Land R Blades of the Access
`Driver and threaded into the vertebral bodies to
`attach the retractor to the spine and provide further
`stabilization. First, the location of the vertebra
`where the screw will engage is identified. Then,
`the absence of nerves and segmental vessels
`are verified using direct visualization and the
`NVMS" Ball Tip Probe (Fig. 48). A Fixation Shim is
`attached to the Fixation Shim Driver, placed down
`the Blades, and threaded into the vertebral body
`under fluoroscopic guidance (Fig. 49). Once the
`Fixation Shims are placed, the Blades should not be
`adjusted. The MaXcess Fixation Shims should not
`be used for vertebral body distraction. A hemostatic
`agent should be used following removal of the
`Fixation Shims to minimize bleeding and the risk of
`hematoma formation.
`
`(Fig. 48)
`
`(Fig. 49)
`
`21
`
`NUVA_ATEC0015589
`
`

`

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`/
` 49
`~- MAS MAXIMUM ACCESS SURGICAL PLATFORM
`
`X LI F" S U R G I CAL TE C H N IOU E
`
`STEP 8:
`ANNULOTOMY AND DISC
`SPACE PREPARATION
`The Annulus Cutter is used to create an annulotomy
`template (either 18mm or 22mm in A/P length,
`depending on the desired implant size) on the
`lateral face of the disc, leaving at least 1 mm to 2mm
`of annulus between the Locking lntradiscal Shim
`and the template (Fig. 50). Following this step, an
`annulotomy is created with the Annulotomy Knife
`(Fig. 51). Disc preparation instruments are passed
`along both endplates and completely through the
`contra lateral annulus (Fig. 52). Contralateral annulus
`release 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,
`Rasps, and other disc preparation instruments can be
`used to thoroughly evacuate the disc and prepare the
`end plates for fusion (Fig. 53).
`
`(Fig. 50)
`
`(Fig. 51)
`
`(Fig 52)
`
`(Fig. 53)
`
`22
`
`NUVA_ATEC0015590
`
`

`

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`
`STEP 9:
`IMPLANT SIZING
`A CoRoent" XL Trial is threaded onto the Inserter,
`and the thumb-wheel lock is tightened to secure the
`Trial (Fig. 54). Under A/P fluoroscopy, the Trial is
`gently impacted into the disc space until centered to
`determine the desired implant size (Fig. 55). Proper
`anterior/posterior position is verified using lateral
`fluoroscopy (Fig. 56).
`
`If satisfied with placement and fit of the Trial,
`surgeon can remove the Trial from the disc space.
`The Slap Hammer can be used, if necessary, to
`facilitate Trial removal.
`
`(Fig. 54)
`
`(Fig. 55)
`
`(Fig. 56)
`
`23
`
`NUVA_ATEC0015591
`
`

`

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`l_ MAS,. MAXIMUM ACCESS SURGICAL PLATFORM
`
`X LI F~ S U R G I CAL TE C H N IOU E
`
`APPLICATION-SPECIFIC SOLUTIONS
`NuVasive® provides a full portfolio of interbody solutions with a variety
`of applications via the CoRoent® XL platform.
`
`XL (18mm wide)
`
`XL-W (22mm wide)
`
`XL-XW (26mm wide)
`
`XL-F (18mm wide)
`
`Xl-F Wide (22mm wide)
`
`Implants offered in rt and 10° lordosis.
`
`XL-CT (Coronal Tapered)
`
`XL-T (Thoracic)
`
`X-CORi:- 2 Expandable VBR
`
`XL-H (Hyperlordotic)
`
`Implant Indications for Use can be referenced at www.nuvasive.com/elFU.
`
`24
`
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`
`

`

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` 49
`
`STEP 10:
`IMPLANT PLACEMENT
`The appropriate implant from the CoRoenr XL
`portfolio is selected and filled with graft material.
`Refer to the CoRoent XL brochure for detailed
`implant selection information.
`
`A loading block can be used to ensure that the
`CoRoent XL graft windows are completely filled
`(Fig. 57).
`
`(Fig. 57)
`
`25
`
`NUVA_ATEC0015593
`
`

`

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`l_ MAS-· MAXIMUM ACCESS SURGICAL PLATFORM
`
`X LI F" S U R G I CAL TE C H N IOU E
`
`STEP 10:
`IMPLANT PLACEMENT (CONT.)
`XUF" Slides may be used to protect the endplates
`and contain graft material during implant insertion.
`Fluoroscopy should be used to verify XLIF Slides
`are positioned properly. The Inserter is placed with
`the attached implant between the XLIF Slides. The
`implant is advanced across the disc space under A/P
`fluoroscopy.
`
`During insertion of the implant, placement is also
`monitored with NVMS" Free Run EMG. Placement of
`the implant is dictated by patient anatomy and the
`spinal pathology that is being treated. Generally, the
`implant spans the ring apophysis, is centered across
`the disc space from a medial/lateral perspective, and
`is near the center of the disc space from an anterior/
`posterior perspective (Figs. 58, 59).
`
`All CoRoent" XL implants have titanium markers that
`can be used to confirm correct implant alignment
`(Figs. 60-62).
`
`(Fig. 58)
`
`(Fig 59)
`
`26
`
`(Fig. 60)
`
`(Fig. 61)
`
`(Fig. 62)
`
`NUVA_ATEC0015594
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 253-9 Filed 01/18/20 PageID.22501 Page 30 of
` 49
`
`STEP 10:
`IMPLANT PLACEMENT (CONT.)
`CoRoent" XL implants may also be inserted with the
`TL Graft Containment Slide. The implant is attached
`to the Inserter, and the TL Graft Containment
`Slide is snapped onto the Inserter. The implant is
`gently impacted into the disc space as the TL Graft
`Containment Slide keeps graft material inside the
`implant (Fig. 63).
`
`(Fig. 63)
`
`27
`
`NUVA_ATEC0015595
`
`

`

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`l_ MAS.• MAXIMUM ACCESS SURGICAL PLATFORM
`
`X LI F~ S U R G I CAL TE C H N IOU E
`
`STEP 11 :
`XLIF" DECADE™ PLATE
`The XLIF Decade Plate is the latest advancement in
`single-approach lateral fusion and fixation. A brief
`overview of the XLI F Decade Plate is described below.
`For additional details on the XLIF Decade Plate, please
`refer to the appropriate surgical technique.
`
`The Plate size is taken in accordance with the
`interbody height. The appropriate Plate size is
`selected and secured to one of the two available Plate
`Inserter options. The Plate is inserted through the
`surgical exposure and centered over the interbody
`and disc space (Fig. 64). Optionally, the Guide Pins
`can be used with the 4-Hole Plate to guide the Plate
`into position. The Guide Pins are delivered using the
`Guide Pin Inserter, and are positioned