IZI Medical Kiva User manual

Procedural Technique Guide

2
Kiva VCF Treatment System Procedural Technique Guide
The information presented in this guide is intended to supplement the Instructions for Use for the Kiva VCF Treatment System
and is not intended as a spine surgery tutorial. For complete information regarding the indications for use, precautions, warnings,
contraindications, adverse events, etc., please reference the Kiva VCF Treatment System’s Instructions for Use.
SYSTEM DESCRIPTION
The Kiva VCF Treatment System consists of the single-use Deployment System, which contains the Kiva Coil and
Kiva Implant, and a set of Access Tools intended for use in the treatment of vertebral compression fractures.
Kiva Deployment Handle
1. Implant Drive Knob
2. Coil Drive Knob
3. Coil Indicator
4. Implant Lock
5. Release Lever
6. Deployment Cannula
7. Kiva Coil
7
6
2 1
4
5
3

3
20 mm
Up to
15 mm
SYSTEM Description
Kiva Implant (Housed within the Kiva Deployment Handle)
Access Tools 1. Bone Access Needle – Diamond Trocar Tip (11G)
2. Bone Access Needle – Bevel Tip (11G)
3. Guide Pins
4. Working Cannula and Dilator (6G)
5. Rigid Cement Delivery Needle
6. UltraFlex Cement Delivery Needle
7. Cement Needle Guide
1
2
4
3
5
6
7

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Bone Drills
Kiva Pilot – Right or Left
Bone Biopsy Devices
Additional A la Carte Accessories – Sold Separately
See labeling for accessory products sold separately.

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INDICATIONS
The Kiva VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures of the thoracic
and/or lumbar spine from T6-L5. It is intended to be used in combination with the IZI Vertebral Augmentation
Cement Kit.
CONTRAINDICATIONS
• Infection, systemic or local, such as osteomyelitis or discitis, to the surgical site is a contraindication for
any spinal surgical procedure.
• Any medical condition that would preclude the patient from having surgery or would impede the benet of
surgery such as spinal cord compression or abnormal anticoagulation status/uncorrectable coagulopathy.
• Neurologic signs/symptoms related to the compression fracture.
• Previous surgical treatment for a compression fracture on the same vertebral body.
• Index level(s) vertebral body collapse to the degree that access to the vertebral body is not feasible.
• Sclerotic cancellous bone.
• Paget’s disease.
• Pedicle(s) not large enough to accept a 5mm cannula (if using a transpedicular approach).
• Evidence of fracture fragments retropulsed into the spinal canal.
See also WARNINGS, PRECAUTIONS, and ADVERSE EFFECTS sections of this guide.

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Retract the Kiva Coil into the
Deployment Cannula by rotating
the (blue) Kiva Coil Drive Knob in
the reverse (-) direction until it is
completely inside the opening of
the distal end and a hard stop has
been detected.
The Coil Indicator will read “0”. Be
careful not to over-retract the Kiva
Coil beyond this position, otherwise
the handle will be unusable.
The Kiva VCF Treatment System
is now ready to use.
Select either the Right or Left Access Kiva System based on the desired pedicle access.
Tip of Deployment Cannula
Coil Indicator on Handle
SYSTEM SET-UP

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Transpedicular Vertebral Body Access
AP view landmarks:
1. Lateral border of pedicle
2. Middle/center of pedicle
3. Medial border of pedicle
4. 4 - 5 mm lateral to midline
Lateral view landmarks:
1. Posterior aspect of pedicle
2. Entry into vertebral body
3. ¼ across vertebral body
4. 2 - 3 mm from anterior cortex
Access the vertebral body using a
standard transpedicular approach
with the Bone Access Needle with
tip of choice.

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If initial access is a
struggle, this may be an
indication you’re working
with hard bone. Using
a Bone Drill instead of
struggling with a mallet
will facilitate subsequent
access and removal of the
Working Cannula.
Transpedicular Vertebral Body Access
Target placement for the Bone Access Needle
is half-way across the vertebral body, 1 - 2 mm
below the superior endplate.
Remove the Bone Access Needle stylet and
advance Guide Pin through the lumen to the
desired depth within the bone. Remove the
Bone Access Needle while leaving the Guide
Pin in place.

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Insert the Working Cannula and
Dilator over the Guide Pin and into the
vertebral body until the tip of the Dilator
is positioned*:
2 - 3 mm from the anterior cortex,
1 - 2 mm below the superior endplate,
and 4 - 5 mm lateral to midline
The Guide Pin may be removed while
leaving the Dilator and Working Cannula
in place once the Dilator has been
advanced past the posterior 1/3 of the
vertebral body.
The Bone Drill may also be used to
gain access into the vertebral body.
To use bone drill, remove Dilator from
Working Cannula and insert bone drill
over guide pin. Please refer to the
individual IFU for each Bone Drill.
The nal position of the Dilator is where
the tip of the Deployment Cannula will
be positioned.
*If a biopsy is necessary, place the Dilator and Working Cannula where desired within the vertebral body for optimal biopsy
sample. Remove Dilator and obtain biopsy using preferred biopsy device. Once the biopsy is completed, re-insert Dilator
and continue advancing until optimal Dilator and Working Cannula placement is achieved.
Rotate the Dilator handle counter-
clockwise to unlock position, remove
the Dilator, and leave the Working
Cannula in place.
Verify that the Working Cannula tip
has cleared the posterior wall of the
vertebral body.
Placement of the Dilator and Working Cannula
TIP
If bone is hard, rotate
Working Cannula and
Dilator 360° prior to
next step.

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Amount of Kiva Coil Deployed
Red Bar - Kiva Coil has been fully deployed
Kiva Coil has been fully retracted
Deployment of the Kiva Coil is controlled by the Kiva Coil Drive Knob
(blue). The Knob is labeled “COIL” and features a “+” sign to indicate
direction for the advancement of the Kiva Coil. The Coil is retracted by
rotating the Knob in the opposite direction.
Deployment of the Kiva Implant is controlled by the Implant Drive Knob
(white). The Knob is labeled “IMPLANT” and features a “+” sign to
indicate direction for the advancement of the Implant.
The Kiva Implant can only be advanced and not retrieved. Reversal of the
Implant Drive Knob will only retract Implant pusher but not the Implant.
The Coil Indicator will show the advancement and/or retraction of the
Kiva Coil only:
Operation of Deployment Handle and Coil Indicator
Kiva Coil tip is inside Deployment Cannula

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Insert the Deployment Cannula into the
Working Cannula with the Deployment
Handle aligned to midline.
Once the Deployment Cannula is
docked to the Working Cannula, rotate
the Deployment Handle 90 degrees
clockwise to lock into Working Cannula.
The distal tip of the Deployment Cannula
should be positioned 2 - 3 mm from the
anterior cortex of the vertebra. Placement
of Deployment Cannula to posterior may
result in the Kiva Coil deploying into the
posterior wall.
Locking of Deployment Handle

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-5°
-15°
Rotate the Kiva Coil Drive Knob one
quarter (¼) turn forward to begin
deploying the Kiva Coil.
Verify under uoro that the Kiva Coil
is deploying toward the midline of the
vertebral body with an inferior trajectory
of -5 to -15 degrees relative to the
transverse plane.
If re-orientation of the Kiva Coil tip is
necessary, fully retract Kiva Coil tip
into the Deployment Cannula prior to
adjusting, until the hard stop is felt.
The deployment plane and orientation
can be adjusted at this time by rotating
the Deployment Handle caudal or
cephalad to achieve the desired
orientation. All adjustments to the
orientation should be conducted under
uoroscopic visualization.
The Deployment Handle may
occasionally require substantial
reorientation to attain the desired
Coil trajectory. In these cases, the
Deployment Handle may be rotated
more drastically than the resulting
Coil trajectory. Prior to deploying the
implant, position the Deployment
Handle in line with the attained Coil
trajectory. The Coil should be centered
in the Deployment Cannula window
when viewed on an AP image. Failure
to complete this step may result in high
friction during implant deployment.
Advance the Kiva Coil until 2 loops
of Coil have been deployed or until
resistance is encountered that prevents
further advancement.
Deployment of Kiva Coil and Implant
TIP
Try to establish the desired trajectory
within the rst 5 Coil deployment
attempts. If more than 5 attempts
are required to establish implant
trajectory, it is important to monitor
the Coil diameter upon deployment.
In some cases, you may have to judge
the trade off between establishing a
perfect trajectory angle and the number
of deployment attempts required to
achieve this.
TIP
Take a radiographic image
after each quarter turn of
the Kiva Coil Drive Knob to
verify proper Coil position
during the deployment of
the rst loop.
TIP
If the top loop of the Kiva
Coil begins to expand
radially, retract Kiva Coil
in ¼ turn increments until
stack is corrected. Advance
Implant to tip of Kiva Coil to
reduce radial expansion.
TIP
If signicant resistance
is met at ¼ to ½ loop of
Kiva Coil deployment prior
to Implant deployment,
attempt a new trajectory at a
different angle.

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If a new trajectory does not improve Coil advancement,
retract Kiva Coil tip just into cannula then remove
Delivery System, leaving Working Cannula in place.
Insert Kiva Pilot (Right or Left to match Kiva System)
through Working Cannula, with the handle aligned to
midline. Rotate Pilot Handle clockwise while holding
device by wings, to lock into Working Cannula.
Kiva Pilot features a wire of larger diameter than the Kiva Coil which creates a channel
that will facilitate deployment of a minimum of one loop of Kiva Coil and Implant.
Actuation of the Kiva Pilot is controlled by the knob on the proximal end of the
device. The Knob features a “+” sign for the advancement and a “-“ sign to indicate
the retraction direction of the Kiva Pilot wire.
Eight (8) full turns of the Drive Knob are required to deploy the full loop of Pilot wire.
Once Kiva Pilot has created a channel, retract Kiva Pilot wire and remove from
Working Cannula.
Reinsert Kiva Delivery System and proceed with Kiva Coil deployment.
If the Kiva Pilot encounters too much resistance to deploy fully, do not continue to
advance. Retract wire and re-orient trajectory in a different angle.
Ensure Kiva Pilot
handle body is aligned
with Working Cannula.
Deployment of Kiva Coil and Implant

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Once 1½ to 2 loops of Kiva
Coil have been delivered,
depress Implant Lock
(orange button) to unlock
the Kiva Implant Knob.
Deployment of Kiva Coil and Implant
Deploy one loop of Implant to anchor
the Implant into the vertebral body.
The implant marker is located 2
mm from the distal tip of the Kiva
Implant.
If radial expansion occurs during
Implant deployment, retract the
Implant Drive Knob ¼ turn, and
then retract the Kiva Coil ¼ turn.
This action may allow the Implant
to partially recover its ideal coil
orientation and provide better
overall stacking.
Continue advancing the Kiva Coil
followed by Implant in ½ to 1 full turn
increments until the desired amount
of Implant has been deployed. Do
not advance the Implant beyond the
distal tip of the Kiva Coil.
Check A/P and lateral images
frequently to verify proper Kiva Coil and
Implant deployment.
A hard stop will indicate when the Kiva
Coil is fully deployed.
Procedure Endpoints:
• Treatment goals have been achieved.
• Entire Implant has been deployed (5 loops). A mild buzzing sound is heard and the Implant Drive Knob will spin freely at this point.
• Bone density does not allow further Kiva Coil or Implant deployment. A safety clutch will engage at this point within the Deployment
Knobs and a distinct clicking will be heard when driving knobs forward.
• Excessive bowing of the Kiva Implant occurs such that it approaches the cortical wall.

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Once the desired amount of Implant has been deployed,
retract the Implant Drive Knob until a hard stop is felt. 
Retract the Kiva Coil beyond the rst hard stop and
continue retracting until the Coil Indicator begins to
show red in the window, along with the blue eject arrow
that matches the arrow on the release lever. A hard stop
is felt at this point.
Use uoroscopic imaging to ensure complete retraction
of the Kiva Coil from the vertebral body prior to removing
the System.
Once the Kiva Coil Indicator shows the blue
eject arrow, deploy the Release Lever to separate
handle from distal cartridge. Remove the handle
by pulling it straight up - do not twist handle.
Insert Cement Needle Guide into Distal Cartridge
with the word “Cranial” pointing cranially until
it docks against the Kiva Implant within the
Cartridge.
Break off proximal end of Cement Needle Guide
at score mark closest to Distal Cartridge so that
it is ush (or near ush) with the hub of the
Deployment Cannula.
Kiva Coil Removal and Bone Cement Delivery

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Mixing and Injection System
1. Cement Injector
2. Extension Tube
3. Mixing Vial
4. Mixing Ball
5. Funnel
6. Cranks
Bone Cement
1. Powder Container
2. Monomer Vial
12
6
1
2
54
3
IZI Medical Vertebral Augmentation Cement Kit
The IZI Medical Vertebral Augmentation Kit is comprised of radiopaque polymethyl methacrylate (PMMA) bone
cement and an injection system for use with the Kiva VCF Treatment System.

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Cement Working Time
Cement handling times as a function of room temperature when used with the Kiva VCF Treatment System.

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Cement Mixing Procedure
•Fully retract the Injector plunger.
•Open Mixing Vial and place Funnel.
•Drop Mixing Ball into Vial.
•Open Cement Powder Container and
transfer ALL contents into Mixing Vial.
•Remove Funnel and securely fasten lid onto Mixing Vial.
•Shake vigorously. You MUST hear the Mixing
Ball moving back and forth in the Vial.
Total shaking and mixing time: 30 seconds.
•Verify there are no clumps of powder and
uniformity of cement throughout mixing process.
Break open Monomer Vial and pour ALL of the liquid into Mixing Vial.
Remove blue cap from bottom of Mixing Vial.
TIP
All monomer must be transferred to Powder Vial to ensure proper cement
formulation. Once the Monomer has been transferred into powder, do
not hold Powder Container with palm of hand. Body heat will transfer to
cement and may shorten its working time.

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Cement Mixing Procedure
Attach Mixing Vial to Cement Injector.
While holding vertically, draw cement SLOWLY into Cement
Injector by pulling plunger back until the plunger reads 10cc.
Pressurize the Mixing Vial by fully advancing the Injector Plunger.
Activate threaded plunger by rotating dial at
the base of Cement Injector until arrows meet.