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Steerable Balloon and Straight Balloon Catheter
I N S T R U C T I O N S F O R U S E
Device is sterile. Do not reuse and do not re-sterilize.
INDICATIONS FOR USE
The Arcadia™ steerable and straight balloon catheters are intended to be used for the
reduction and fixation of fractures and/or creation of a void in cancellous bone in the
spine. This includes use during percutaneous vertebral augmentation. These balloon
catheters are to be used with cleared spinal polymethylmethacrylate (PMMA) bone
cement for use during percutaneous vertebral augmentation, such as kyphoplasty.
DEVICE DESCRIPTION
The Arcadia balloon catheters consist of a Y-Adapter with a dual-lumen catheter shaft
and a balloon. The inner shaft lumen contains a stylet (either straight or articulating),
the outer lumen is an inflation conduit for the balloon. Two marker bands are printed
on the shaft and serve as indicators of when the distal tip of the balloon catheter has
reached the distal end of the working cannula of the StabiliT® Introducer. The distal
marker band correlates with the short StabiliT Introducer and the proximal marker
band correlates with the long StabiliT Introducer.
The Arcadia steerable balloon catheter features a steerable mechanism that enables
the steering of the device. The steerable mechanism assists the clinician in directing
the balloon catheter through a pre-existing channel by turning the steering handle
clockwise to articulate the distal portion of the device.
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Radiopaque Markers
Radiopaque Markers
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CONTRAINDICATIONS
• Instability of posterior wall and/or pedicles.
• Should not be used if vertebral dimensions or fracture pattern do not allow safe
placement and inflation of the balloon.
• Infection.
• Bleeding disorder or treatment that increases the chance of excessive bleeding.
• Any known allergy to bone cement.
• Any known allergy to contrast material.
• Pregnancy.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a
physician.
WARNINGS
• Use the device prior to the "Use By" date noted on the package. Do not use this
product after the expiration date printed on the package. The device may not be
safe or effective beyond its expiration date.
• Inflating the balloon beyond the maximum inflation volume may cause the balloon
to rupture before reaching the maximum inflation pressure of 700 psi.
• Inflating the balloon beyond the maximum inflation pressure may cause the
balloon to rupture before reaching the maximum inflation volume.
• The balloon may rupture due to contact with bone splinters, bone cement, and/or
surgical instruments.
• Do not inflate the balloon until it has been fully deployed in the vertebral body.
Inflating the balloon prior to full deployment may result in balloon failure due to
contact between the balloon and the working cannula.
• Breakage of the device may require intervention and/or retrieval.
• Never use any air or any gaseous medium to inflate the Arcadia balloons. Use only
the recommended minimum 60% contrast medium.
• For a transpedicular approach, if the pedicle is not large enough or stable enough
to withstand the procedure, pedicle fracture may occur.
• Complications that may occur during a parapedicular approach include
pneumothorax and bleeding.
PRECAUTIONS
• It is important to read the Instructions For Use carefully prior to use.
• 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.
• The balloons should be manipulated only while under fluoroscopic observation
with radiographic equipment that provides high quality images.
• It is essential to maintain a strict sterile technique during the procedure and during
all phases of handling this product.
• DO NOT use if package is opened or damaged. All devices are provided sterile. All
devices are sterilized using gamma radiation.
Figure 1: Arcadia Steerable Balloon Catheter
Exit Marker Bands
Figure 2: Arcadia Straight Balloon Catheter
Exit Marker Bands
Steerable Handle
Inflation Port
Removable Stylet
Inflation Port
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