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.