MAXIMUM ACCESS SURGICAL PLATFORM
`
`Surgical Technique
`
`NUVASIVE - EXHIBIT 2038
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
`
`

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`CONTENTS
`
`Preface
`
`Presurgical Preparation
`
`
`
`
`
` Equipment Requirements
`
` Surgical Considerations
`
`XLIF ® Surgical Technique
`
`
`
`
`
`
`
` Patient Positioning & O.R. Setup
`
` Anatomic Landmark Identification & Initial Incisions
`
` Retroperitoneal Access
`
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` Retroperitoneal Approach
`
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` Transpsoas Approach
`
` XLIF Electrode Installation and Retractor Assembly
`
` Access
`
` Annulotomy & Disc Space Preparation
`
` Implant Sizing
`
` Application Specific Solutions
`
` Implant Placement
`
` XLP® Plate
`
` XLIF Applications
`
` Removal and Closure
`
`XLIF System
`
`Catalog
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`

`

`PREFACE
`
`Fellow Colleagues,
`
`XLIF® was created to be a safer and more reproducible, minimally disruptive procedure that utilizes conventional surgical techniques and a
`seamlessly intergrated 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. XLIF 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, XLIF is minimally disruptive while utilizing conventional surgical techniques. Over the years, the XLIF
`procedure and technology has evolved. However, two systems, described below, continue to help enable safer and more reproducible minimally
`disruptive spine surgery.
`
`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., endoscope, monitor), the MaXcess
`4 Access System enables direct illuminated visualization of the patient’s anatomy through conventional methods.
`
`The NVM5® system is another important technology that helps to enable safer and 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 direct lateral, retroperitoneal, transpsoas approach to access the intervertebral disc. NVM5 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. NVM5 is the only clinically validated nerve avoidance system for safety
`and 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 indications 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 XLIF 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
`São Paulo, Brazil
`
`
`
`1
`
`

`

`PRESURGICAL PREPARATION
`
`EQUIPMENT REQUIREMENTS:
`To successfully complete this technique, the following patient positioning supplies, instruments,
`implants, and fixation options are required.
`
`PATIENT POSITIONING:
`• 3 Inch 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 (optional)
`• XLIF® Instruments
`• Anterior/Lateral General Instruments
`• NVM5®
`• NVM5 XLIF Dilator Kit
`• NVM5 EMG Module
`
`IMPLANTS:
`• CoRoent® (XL, XL-W, XL-XW, XL-CT, XL-F, XL-FW, XL-K, XL-T)
`
`LATERAL FIXATION OPTIONS:
`• XLP®
`• XLP Plus
`
`POSTERIOR FIXATION OPTIONS:
`• Precept®
`• Armada®
`• SpheRx® II
`• SpheRx DBR III
`• SpheRx PPS
`• SpheRx PPS + EXT
`• Radian® Facet Screws
`
`Reference the CoRoent, MaXcess 4, NVM5, SpheRx II, SpheRx DBR III, Armada, Precept, Radian,
`and XLP Surgical Technique(s) or Reference Manual(s) and/or Instructions for Use (IFU) for
`additional important labeling information.
`
`2
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`

`

`PRESURGICAL PREPARATION
`
`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-
`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 anteriorly and create a space through
`which the Dilators and retractor will pass. The initial XLIF 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 NVM5® 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.
`
`3
`
`

`

`STEP 1:
`PATIENT POSITIONING & O.R. SETUP
`Under AP 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, then
`secured to the table with padding placed
`between knees (C)
`
`From the table to the knee, past the ankle, 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, the surgical table
`may be flexed 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.
`
`D
`
`C
`
`A
`
`B
`
`(Fig. 1)
`
`(Fig. 2)
`
`ILIAC
`CREST
`
`RIBS
`
`4
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 1:
`PATIENT POSITIONING & O.R. SETUP (CONT’D)
`
`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 positioned and the NVM5
`electrodes are in place (see NVM5 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 Twitch Test is conducted
`(Fig. 4).
`
`(Fig. 3)
`
`(Fig. 4)
`
`5
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`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 1:
`PATIENT POSITIONING & O.R. SETUP
`(CONT’D)
`Once the patient is secured, the table should
`be adjusted so that the C-Arm provides true AP
`images when at 0° (distinct endplates and pedicles
`symmetrical about the spinous 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 NVM5® control unit should be placed opposite
`the surgeon to enable an unobstructed view (Fig. 7).
`
`(Fig. 5)
`
`(Fig. 6)
`
`FLUORO
`MONITORS
`
`FLUORO
`
`NVM5
`
`ANESTHESIA
`
`(Fig. 7)
`
`6
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`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`SUPERIOR
`
`ANTERIOR
`
`(Fig. 8)
`
`POSTERIOR
`
`(Fig. 9)
`
`7
`
`XLIF ® SURGICAL TECHNIQUE
`
`(1)
`
`(2)
`
`STEP 2:
`ANATOMIC LANDMARK IDENTIFICATION
`& INITIAL INCISIONS
`Following standard surgical preparation, the disc
`space is localized using lateral fluoroscopy (Fig. 8).
`
`Using the Targeting Instrument, longitudinal marks
`are made 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).
`
`(3)
`
`INFERIOR
`
`(4)
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 3:
`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 abdominis 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 anteriorly (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. 10)
`
`(Fig. 11]
`
`8
`
`(Fig. 12)
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`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).
`This step ensures that a pathway exists between the
`abdominal wall and the psoas muscle.
`
`A skin and fascial incision is made at this location
`(Fig. 14) followed by blunt dissection through muscle
`planes and the transversalis fascia. Then 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. 16).
`
`(Fig. 13)
`
`(Fig. 14)
`
`(Fig. 15)
`
`(Fig. 16
`
`9
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`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 5:
`TRANSPSOAS APPROACH
`
`IMPORTANCE OF NEUROMONITORING:
`Neuromonitoring is critical 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.
`
`XLIF® relies on the clinically validated dynamic EMG
`nerve avoidance mode of NVM5® to identify a safer
`docking position and working area.1
`
`NVM5 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, the location is verified 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
`NVM5 favorably allows (Fig. 17).
`
`The Dynamic Stimulation Clip is attached to the initial
`Dilator and NVM5 is activated in XLIF mode. The initial
`Dilator is then passed medially through the psoas, while
`slowly being rotated 360° to determine the three-
`dimensional position of the nerves.2 NVM5 will display
`the continually updated threshold stimulation that triggers
`a neural response (Fig. 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
`NVM5 monitor will display a higher threshold. If alert-
`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
`indicates 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 NVM5 Quick Reference
`Manual in the help section on the NVM5 screen.
`
`1 Uribe JS, et.al. J Neurosurg Spine 13:260-266, 2010
`2 Tohmeh AG, et. al. J Neurosurg Spine 14:31-37, 2011
`
`10
`
`(Fig. 17)
`
`(Fig. 18)
`
`(Fig. 19)
`
`(Fig. 20)
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 5:
`TRANSPSOAS APPROACH (CONT’D)
`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 NVM5®.
`
`A cross-table AP 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, a
`K-Wire is introduced about halfway into the disc space
`to secure the position. Laser markings on the K-Wire at
`10mm intervals may assist in reaching optimal K-Wire
`depth. 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 XLIF® Dilators (magenta and blue) are
`subsequently introduced over the initial Dilator using
`a twisting motion. NVM5 is used as with the previous
`Dilator to determine nerve proximity.
`
`(Fig. 21)
`
`(Fig. 22)
`
`(Fig. 23)
`
`11
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`XLIF ® SURGICAL TECHNIQUE
`
`

`

`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, 25, 26).
`
`(Fig. 24)
`
`(Fig. 25)
`
`(Fig. 26)
`
`12
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`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 6:
`XLIF® ELECTRODE INSTALLATION AND
`RETRACTOR ASSEMBLY (CONT’D)
`To assemble the Access Driver, the lines of the center
`arm should be aligned 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 L and R handles can
`be attached to the Access Driver by depressing the
`button and sliding toward the retractor body.
`
`(Fig. 27)
`
`(Fig. 28)
`
`13
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`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 7:
`ACCESS
`The Access Driver is introduced over the third Dilator
`with the handles pointing posteriorly. The NVM5®
`Dynamic Stimulation Clip may be attached to the
`cylindrical lead at the proximal tip of the XLIF®
`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 AP fluoroscopy 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 L and R Blades will align with the bottom corners
`of the C Blade Targeting Window when the retractor
`is in line with the C-Arm, and thus the disc space, and
`parallel with the floor (Fig. 30).
`
`14
`
`(Fig. 30)
`
`(Fig. 29)
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 7:
`ACCESS (CONT’D)
`The Articulating Arm bedrail attachment should be
`attached to the bedrail of the table (Fig. 31). The
`Articulating Arm post is passed through the bedrail
`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 to retractor body.
`
`(Fig. 31)
`
`(Fig. 32)
`
`15
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`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 7:
`ACCESS (CONT’D)
`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 L and R Blades moving anteriorly when opened
`to minimize pressure at the posterior portion of the
`psoas muscle, where the majority of the lumber
`plexus nerves are located (Fig. 33). The silver
`Articulating Arm attachment point is primarily used for
`thoracic applications and affixes the L and R Blades
`to the table which results in the C Blade moving
`posteriorly when opened (Fig. 34).
`
`16
`
`(Fig. 33)
`
`(Fig. 34)
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 7:
`ACCESS (CONT’D)
`The handles of the Access Driver are
`squeezed one click to open the Blades in the
`cephalad/caudal direction (Fig. 35).
`
`Initial anterior exposure is achieved by
`turning the knobs on the sides of the Access
`Driver one click in the direction of arrows
`(Figs. 36, 37).
`
`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. 38).
`
`(Fig. 35)
`
`(Fig. 38)
`
`17
`
`(Fig. 36)
`
`(Fig. 37)
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 7:
`ACCESS (CONT’D)
`Any residual tissue at the bottom of the exposure
`is thoroughly explored, using the NVM5® Probe to
`confirm that no nerves are within the exposure
`(Fig. 39).
`
`Shims are available in various sizes to both effectively
`widen and lengthen the Blades to keep tissue out of
`the exposure. A Locking Intradiscal 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 Intradiscal 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. 40). The Locking Shim
`Repositioning Tool is used to introduce the Locking
`Intradiscal Shim into the disc space (Fig. 41). To
`disengage the Locking Shim Repositioning Tool from
`the Locking Intradiscal Shim, depress the button (Fig.
`42). The Locking Intradiscal Shim may also be removed
`with the Locking Shim Repositioning Tool (Fig. 43).
`
`(Fig. 39)
`
`(Fig. 40)
`
`(Fig. 41)
`
`18
`
`(Fig. 42)
`
`(Fig. 43)
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 7:
`ACCESS (CONT’D)
`
`Additional Shims can optionally be placed
`down the Blades to increase the Blade length
`or width (Fig. 44). A Penfield, Nerve Retractor,
`or Psoas Retractor can be used to tuck residual
`tissue behind the shims (Figs. 45-48). Bipolar
`electrocautery can be used, if necessary,
`to further prepare for disc visualization.
`Monopolar electrocautery is best avoided to
`prevent inadvertent nerve injury.
`
`(Fig. 44)
`
`(Fig. 45)
`
`(Fig. 46)
`
`(Fig. 47)
`
`(Fig. 48)
`
`19
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 7:
`ACCESS (CONT’D)
`If patient anatomy dictates, the Blade Rotation Driver
`can be used to rotate the left and/or right Blades
`independently (Fig. 49). This will expand the distal
`exposure and may assist in preferentially adjusting
`the exposure cephalad or caudal (e.g., caudal at
`L4-L5 under iliac crest) to gain optimal access to the
`disc space (Fig. 50). 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 AP
`fluoroscopy.
`
`The cephalad/caudal exposure should only be as wide
`as is necessary to prepare the disc space (Fig. 51).
`Wider exposure unnecessarily increases psoas muscle
`trauma. 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.
`52). It is recommended that the Anterior Retractor is
`removed during any steps that involve impaction.
`
`(Fig. 49)
`
`(Fig. 50)
`
`20
`
`(Fig. 51)
`
`(Fig. 52)
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 7:
`ACCESS (CONT’D)
`
`FIXATION SHIMS (OPTIONAL)
`Following placement of the Locking Intradiscal Shim
`and any nessessary rotation of the left and right
`blades, MaXcess® Fixation Shims can optionally be
`placed down the L and 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 NVM5® Ball Tip Probe (Fig.
`53). A Fixation Shim is attached to the Fixation Shim
`Driver, placed down the Blades, and threaded into the
`vertebral body under fluoroscopic guidance
`(Fig. 54). 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. 53)
`
`(Fig. 54)
`
`21
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 8:
`ANNULOTOMY & DISC SPACE PREPARATION
`The Annulus Cutter is used to create an annulotomy
`template, either 18mm or 22mm in AP length
`depending on the desired implant size, on the
`lateral face of the disc, leaving at least 1mm-2mm of
`annulus between the Locking Intradiscal Shim and
`the template (Fig. 55). Following this, an annulotomy
`is created with the Annulotomy Knife (Fig. 56).
`Disc preparation instruments are passed along both
`endplates and completely through the contralateral
`annulus (Fig. 57). 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
`endplates for fusion (Fig. 58).
`
`(Fig. 55)
`
`(Fig. 56)
`
`22
`
`(Fig. 57)
`
`(Fig. 58)
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`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. 59). Under AP fluoroscopy, the Trial is
`gently impacted into the disc space until centered to
`determine the desired implant size (Fig. 60). Proper
`anterior/posterior position is verified using lateral
`fluoroscopy (Fig. 61).
`
`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.
`
`(Fig. 59)
`
`(Fig. 60)
`
`(Fig. 61
`
`23
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`APPLICATION SPECIFIC SOLUTIONS
`NuVasive® is the first company to provide 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 0° and 10° lordosis.
`
`Max. Stability,
`Advanced
`
`XL-CT (Coronal Tapered)
`
`XL-K (Keeled)
`
`XL-T (Thoracic)
`
`X-CORE 2 Expandable VBR
`Tumor/Trauma Corpectomy*
`
`XL-H (Hyderlordotic)
`Anterior Column Realignment*
`
`More
`Complex
`
`Note: FDA PEEK Implant Clearances:
`All PEEK interbody implants are cleared for use as intervertebral body fusion devices at L2-S1 for use with autograft, and supplemental fixation, including the CoRoent
`family of implants.
`
`24
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 10:
`IMPLANT PLACEMENT
`The appropriate implant from the CoRoent® 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. 62)
`
`(Fig. 62)
`
`25
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 10:
`IMPLANT PLACEMENT (CONT’D)
`XLIF 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 AP
`fluoroscopy.
`
`During insertion of the implant, placement is also
`monitored with NVM5® 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. 63, 64).
`
`All CoRoent® XL implants have titanium markers that
`can be used confirm correct implant alignment
`(Figs. 65, 66, 67).
`
`(Fig. 63)
`
`(Fig. 64)
`
`26
`
`(Fig. 65)
`
`(Fig. 66)
`
`(Fig. 67)
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 10:
`IMPLANT PLACEMENT (CONT’D)
`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. 68).
`
`(Fig. 68)
`
`27
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 11:
`XLP® PLATE
`The XLP plate is one of many supplemental fixation
`options available for XLIF. A brief overview of the XLP
`plate surgical technique is described below. Proper
`patient selection and technique is critical to ensure
`success with lateral plating. For additional details on
`the XLP plate or other fixation options, please refer to
`the appropriate product technique guide.
`
`Pilot hole preparation and bolt insertion are
`performed through XLP Guides. The appropriately
`sized 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. 69).
`
`Several instruments are available in the XLP set to
`create pilot holes including taps, drills, and awls. The
`selected instrument(s) should be inserted through
`the XLP Guide and a pilot hole created to the desired
`depth and trajectory (Fig. 70).
`
`28
`
`(Fig. 69)
`
`(Fig. 70)
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`STEP 11:
`XLP® PLATE (CONT’D)
`With a pilot hole prepared, the appropriate length bolt
`is introduced through the Guide barrel and inserted
`to appropriate depth (Fig. 71). Bolt insertion is
`repeated on the adjacent level. Bicortical bolts, placed
`as parallel as possible, are recommended.
`
`With both bolts in place, the appropriately sized
`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.
`
`Prior to final tightening of Lock Nuts, the table should
`be flattened (i.e., table break removed).
`
`Final tightening on both Lock Nuts (Fig. 72)
`completes the procedure (Fig. 73).
`
`(Fig. 72)
`
`(Fig. 71)
`
`(Fig. 72)
`
`(Fig. 73)
`
`29
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`MAS MAXIMUM ACCESS SURGICAL PLATFURM
`
`XL|F® SURGICAL TECHNIUUE
`
`XLIF® APPLICATIONS
`XLIF® APPLICATIONS
`
`DEGENERATIVE DISC DISEASE
`DEGENERATIVE DISC DISEASE
`
`PRE-OP
`PRE-OP
`
`POST-OP
`POST-OP
`
`
`
`DEGENERATIVE SPONDYLOLISTHESIS SECONDARY TO ADVANCED DDD
`DEGENERATIVE SPONDYLOLISTHESIS SECONDARY TO ADVANCED DDD
`PRE-OP
`POST-OP
`PRE-OP
`POST-OP
`
`
`
`30
`30
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`XL|F® SURGICAL TECHNIUUE
`
`XLIF® APPLICATIONS (CONT’D)
`XLIF® APPLICATIONS (CONT'D)
`
`DEGENERATIVE SCOLIOSIS SECONDARY TO ADVANCED DDD
`DEGENERATIVE SCOLIOSIS SECONDARY TO ADVANCED DDD
`PRE-OP
`POST-OP
`PRE-OP
`POST-OP
`
`
`
`ADJACENT SEGMENT DISEASE SECONDARY TO ADVANCED DDD
`ADJACENT SEGMENT DISEASE SECONDARY TO ADVANCED DDD
`PRE-OP
`POST-OP
`PRE-OP
`POST-OP
`
`
`
`3]
`31
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`(Fig. 74)
`
`STEP 12:
`REMOVAL AND 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 Locking Intradiscal Shim should
`be removed from the C Blade prior to removing the
`Access Driver.
`
`The skin is closed using standard surgical techniques.
`
`Supplemental instrumentation is required
`and warranted.
`
`STEP 13:
`IMPLANT REMOVAL
`If it becomes necessary to revise the implanted
`CoRoent device, access to the implantation site can
`be achieved in a similar fashion to the original access.
`Once the implanted device is exposed, it can be
`removed by reattaching the Inserter. If the device
`is difficult to remove, additional engagement or
`dislodging may be achieved with the XLIF Revision
`Instruments.
`
`All supplemental instrumentation should be
`revised in accordance with its respective product
`technique guide.
`
`32
`
`MAXIMUM ACCESS SURGICAL PLATFORM
`
`XLIF ® SURGICAL TECHNIQUE
`
`

`

`MAXCESS® 4 ACCESS SYSTEM
`
`Access Driver Body
`
`Solid Access Driver Body
`
`4th Blade Attachment
`
`Access Driver Handle Left
`
`Access Driver Handle Right
`
`Blades - 90, 100, 110, 120, 130, 140 150mm
`
`Wide Anterior Retractor, Short
`
`Blade Rotation Driver
`
`33
`
`XLIF ® SYSTEM
`
`

`

`MAXCESS® 4 ACCESS SYSTEM (CONT’D)
`
`Targeting Instrument
`
`MaXcess 4 Sterilization Case
`
`Lock Shim Inserter / Repositioning Tool
`
`Lock Shim Removal Tool
`
`MaXcess 4 Sterilization Case, Top Tray
`
`Anterior Crossbar
`
`Electrode Removal Tool
`
`MaXcess 4 Sterilization Case, Middle Tray
`
`Blades - 50, 60, 70, 80mm
`
`MaXcess 4 Steri