StabiliT® Vertebral Augmentation System
(for use with StabiliT ER2 Bone Cement)
Instructions for Use (English) (EN)
Important Information – Please Read Before Use
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
INDICATIONS
The StabiliT Vertebral Augmentation System is intended for percutaneous delivery
of StabiliT ER
Bone Cement inkyphoplasty procedures in the treatment of
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pathological fractures of the vertebrae. Painful vertebral compression fractures
may result from osteoporosis, benign lesions (hemangioma), and malignant lesions
(metastatic cancers, myeloma).
DESCRIPTION
The StabiliT Vertebral Augmentation System is a system for the controlled delivery
of StabiliT ER
Bone Cement in the treatment of vertebral compression fractures. It
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contains an integrated low power bipolar radiofrequency (RF) warming source that
warms the bone cement.
The StabiliT Vertebral Augmentation System consists of eight (8) components
(Figure 1).
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2
8
7
6
5
Figure 1. StabiliT Vertebral Augmentation System
One MultiPlex Controller or MultiPlex II Controller (#1, Controller)(including a
power cord) and seven packaged sterile, disposable assemblies:
• Hydraulic Sub Assembly (HSA) (#2)
• Master Syringe (MS) (#3)
• Activation Element (AE) (#4)
• Locking Delivery Cannula (LDC) (#5)
• StabiliT Introducer - Working Cannula and Stylet(#6)
• AE Cable (#7)
• Hand Switch Cable (#8): The Hand Switch has two button Functions:
- BLUE Button– RF Activated Bone Cement at 1.3 cc/min
o To activate BLUE Button on Hand Switch, PRESS ONCE to engage. PRESS
AGAIN to disengage.
- ORANGE Button – Second Timer
o To activate ORANGE Button on Hand Switch function, press once to
start second timer. To extinguish second timer press and hold for three
seconds.
HOW SUPPLIED
• The Controller (including Power Cord) are provided non-sterile.
• The LDC, StabiliT Introducer, AE, Hydraulic Sub Assembly, Master Syringe, AE
Cable, and Hand Switch Cableare provided sterile. These devices are intended
for single use only. DO NOT re-sterilize and/or reuse. DO NOT use if package is
open or damaged and notify the manufacturer.
CONTRAINDICATIONS
• The use of this product is contraindicated in patients with coagulation disorders,
or with severe pulmonary insufficiency.
• 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.
• 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.
• This product should not be used in patients with sensitivity to any of the
components of the PMMA bone cement.
WARNINGS
• Cement leakage may cause tissue damage, nerve or circulatory problems and
other serious adverse events.
• This device should only be used by qualified physicians with training in the clinical
procedure in which it is being used.
• For safe and effective use of the StabiliT Vertebral Augmentation System, the
physician should have specific training, experience, and thorough familiarity with
the use and application of this product.
• Percutaneous kyphoplasty procedures should only be performed in medical
settings in which emergency decompressive surgery is available.
• It is essential to maintain strict sterile technique during the kyphoplasty procedure
and during all phases of handling this product.
• Precise Locking Delivery Cannula placement is required for this procedure.
Incorrect device placement could result in patient injury.
• The Working Cannula (part of StabiliT Introducer) is not intended for delivering
bone cement. Always use the LDC to deliver bone cement to the vertebral body.
• Insertion of the Working Cannula must be performed with the Stylet in place inside
the Working Cannula.
• The Introducer Stylet or the Osteotome or the LDC must be within the Working
Cannula during, manipulation or repositioning of the Working Cannula.
• Removal of the Working Cannula must be performed by rotation and axial motion.
DO NOT bend the Working Cannula sideways, patient injury may occur.
• Use appropriate imaging techniques to confirm correct LDC placement, 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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4
• Thoroughly read the IFU that is packaged with theStabiliT ER
and the ER
Saturate Mixing System before use.
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• Dispose used product per Local, State and Federal Bloodborne pathogen
controls including Biohazard sharps container and disposal procedures.
• The StabiliT Vertebral Augmentation System can be used in conjunction with the
VertecoR StraightLine Cement Staging Osteotome (per IFU) or VertecoR MidLine
Cement Staging Osteotome (per IFU). Thoroughly read IFUs prior to use.
• Hydraulic Sub Assembly & Master Syringe failure may result in inability to
deliver StabiliT ER
Bone Cement:
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If the Hydraulic Sub Assembly & Master Syringe fails PRIOR to attachment to
the AE press the REMIX/RESTART Button on the Controller and replace with a
new Hydraulic Sub Assembly & Master Syringe.
If the Hydraulic Sub Assembly & Master Syringe fails AFTER bone cement has
been delivered through the AE press REMIX/RESTART Button on the
Controller and replace Hydraulic Sub Assembly & Master Syringe and AE.
• All devices except for the Controller are provided sterile. These devices are
intended for single use only. DO NOT re-sterilize. DO NOT use if package is open
or damaged. Reconditioning refurbishing, repair, modification, or resterilization of
the device(s) to enable further use is expressly prohibited as it may result in loss
of function and/or infection.
• For devices penetrating bone, DO NOT use if dense bone is encountered. Device
damage resulting in patient injury may occur. Breakage of the device may require
intervention for retrieval.
• Instructions For Use (IFU) for each device (if packaged separately or along with
this IFU) must be followed to perform a procedure using the StabiliT Vertebral
Augmentation System.
CAUTIONS
• Examine all packaging prior to opening. DO NOT use device if damaged or the
sterile packaging is breached.
• StabiliT Vertebral Augmentation System will decrease the set time of StabiliT ER
bone cement.
Minimum bone cement Set Time Using StabiliT ER
23°C
With Warming
Without Warming
* With 5:00 minute start time post-mix
• Wear safety glasses or a face shield when delivering the bone cement.
• Ensure that all luer lock connectors are tightened securely. Improperly secured
connections could result in disconnection during injection.
• Exercise
caution
in
cases
involving
significant vertebral collapse (i.e., the vertebral body is less than 1/3 of its
original height). Such cases may lead to a technically difficult procedure.
ADVERSE EVENTS
• Serious adverse events, some with fatal outcome, associated with the use of
acrylic bone cements for vertebroplasty or kyphoplasty include myocardial
infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism and
cardiac embolism. Although the majority of these adverse events present early
within the post-operative period, there have been some reports of diagnoses
beyond a year or more after the procedure.
Myocardial infarction
Cardiac arrest
Cerebrovascular accident
Pulmonary embolism
Anaphylaxis
Diffusion of the bone cement outside the vertebral body: in the peripheral
veins
(pulmonary
embolism),
radiculopathy), in the intervertebral disc
• The most frequent adverse reactions reported with PMMA are:
Transitory fall in blood pressure
Thrombophlebitis
Hemorrhage and hematoma
Superficial or deep wound infection
Bursitis
Short-term cardiac irregularities
Heterotopic bone formation
• Other reported adverse events for acrylic bone cements intended for vertebroplasty
or kyphoplasty include:
Leakage of the bone cement beyond the site of its intended application with
introduction into the vascular system resulting in embolism of the lung and/or
heart or other clinical sequelae.
Pyrexia
Hematuria
Dysuria
Bladder fistula
Transitory worsening of pain due to heat released during polymerization
Nerve entrapment and dysphasia due to extrusion of the bone cement beyond
its intended application
Adhesions and stricture of the ileum due to heat released during polymerization
• Potential adverse events associated with kyphoplasty or vertebroplasty include:
Pneumonia
Intercostal neuralgia
Collapse of a vertebra adjacent to the one injected, due to an osteoporotic
disease
Pneumothorax
Extravasation of bone cement into soft tissue
Fracture of a pedicle
Rib fracture in patients with diffuse osteopenia, especially during thoracic
kyphoplasty procedures, due to the significant downward force exerted during
Delivery Cannula insertion
Compression of the spinal cord with paralysis or loss of feeling
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Bone Cement
2
Bone Cement At
2
35 minutes*
51minutes
extensive
vertebral
destruction
in
the
epidural
plexus
(myelopathy,
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and