CONTENTS
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DiamondTOUCH™ Syringe (#1): For delivering bone cement into the vertebral body.
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Master Syringe and Hydraulic Coupler (#2): Intended for the delivery of StabiliT Bone Cement.
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Cement Delivery Elbow (#3): Connects the Cement Syringe to the Locking Delivery Cannula
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StabiliT Introducer with bevel tip (#4) and diamond tip (#5): Used for percutaneous bone access.
Device
Working Length
StabiliT Introducer, Short
10 cm
StabiliT Introducer, Long
12 cm
Locking Delivery Cannula (LDC) with diamond tip (#6): For percutaneous bone access and bone cement delivery.
Device
Working Length
Locking Delivery Cannula, Short
12.8 cm
Locking Delivery Cannula, Long
14.9 cm
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StabiliT Bone Cement and Saturate Mixing System (#7):
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The StabiliT Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using
a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from
osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
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The Saturate Mixing System is intended for mixing of StabiliT Bone Cement.
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Funnel (#7a)
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Cement Syringe (#7b): Contains StabiliT Bone Cement Powder
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Filter (#7c)
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Stopcock (#7d)
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Locking syringe (#7e)
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Monomer (#7f)
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PowerCURVE Navigating Osteotome (#8): The PowerCURVE Navigating Osteotome is intended for scraping or
coring of bone in the spine. It is to be used with the StabiliT Introducer. The Shaft is 3.0 mm in outer diameter.
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The Deployment Handle (A) is the rotating portion that articulates the distal tip of the device. The Tip
Indicator (B) indicates the direction in which the tip will articulate (C).
Working Length
Exit Marker Length
Tip Articulated
3.2 cm Articulating Tip
Deployment Handle
Tip Indicator
Figure 2: PowerCURVE Navigating Osteotome
Device
Exit Marker
Working Length
PowerCURVE Navigating Osteotome, Short
12.0 cm
15.1 cm
PowerCURVE Navigating Osteotome, Long
14.0 cm
17.1 cm
VertecoR™ StraightLine Cement Staging Osteotome (SLO) (#9); The VertecoR StraightLine Cement Staging
Osteotome is intended for scraping or coring of bone in the spine. It is packaged with a blunt tip stylet. It is to
be used with the StabiliT Introducer. The shaft is 3.0 mm in outer diameter. Table 1: Timing of Various Activities at
Different Ambient Temperatures
Device
Working Length
VertecoR StraightLine Cement Staging Osteotome, Short
13.5 cm
VertecoR StraightLine Cement Staging Osteotome, Long
15.5 cm
HOW SUPPLIED
All components are provided sterile. These devices are intended for single use only. DO NOT re-sterilize and/or
reuse. If package is open or damaged DO NOT use and notify the manufacturer.
CONTRAINDICATIONS
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The use of this product is contraindicated in patients with coagulation disorders, or with severe pulmonary
insufficiency.
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The use of this product is contraindicated in patients with a compromise in the posterior column of the vertebral
body or the walls of the pedicles.
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The use of PMMA bone cement is contraindicated in the presence of active or incompletely treated infection at
the site where the bone cement is to be applied.
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This product should not be used in patients with sensitivity to any of the components of the PMMA bone cement.
WARNINGS
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Cement leakage may cause tissue damage, nerve or circulatory problems, and other serious adverse events.
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Thoroughly read the IFUs for each device including the StabiliT Bone Cement and Saturate Mixing System, (if
packaged separately or along with this IFU) before use. The IFU must be followed to perform a procedure using
the StabiliT MX Vertebral Augmentation System.
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For safe and effective use, this device should only be used by qualified physicians with training in the clinical
procedure in which it is being used. The physician should have specific training, experience, and thorough
familiarity with the use and application of this product.
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Always use image guidance with radiographic equipment that provides high quality imaging to avoid patient
injury. Use appropriate imaging techniques to confirm correct Working Cannula placement (before and during
advancement and after removal); absence of damage to surrounding structures, and appropriate location of
delivered bone cement. Imaging, such as venography, can be used to assess the ability of the vertebra to contain
the delivered bone cement.
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It is essential to maintain strict sterile technique during the procedure and during all phases of handling this
product.
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Precise Working Cannula placement is required for this procedure. Incorrect device placement could result in
patient injury.
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The Working Cannula (part of the StabiliT Introducer) is not intended for delivering bone cement. Always use the
LDC to deliver bone cement to the vertebral body.
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The Introducer Stylet must be in place inside the Working Cannula during use of the Introducer (e.g., insertion,
removal, manipulation).
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Removal of the Introducer must be performed by rotation and axial motion. DO NOT bend the cannula sideways;
patient injury may occur.