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Preparation of the Arcadia Balloon Catheter
• Remove the protective sheath from the balloon prior to use.
• Push plunger all the way into locking syringe. Attach locking syringe to the
inflation port of the Arcadia balloon catheter and pull the plunger back to remove
air from the balloon. Turn plunger to lock it in position on the last slot in the syringe.
• Detach the locking syringe and set balloon aside.
• Prepare inflation device with contrast media according to inflation device
manufacturer's Instructions For Use.
• Attach the luer connecting port on the inflation device tubing to the inflation port
on the Arcadia balloon catheter. The balloon catheter is now ready to use.
Arcadia Balloon Catheter Insertion
• An access channel is required for the Arcadia balloon catheter placement.
• Follow the Instructions For Use for the chosen Merit access instruments to create
the access channel in the bone.
• The steerable balloon catheters will require a channel previously created by the
PowerCURVE Navigating Osteotome.
• Insert the deflated Arcadia balloon catheter into the access channel and position it
under fluoroscopic image guidance using the radiopaque markers. A gentle
twisting motion with the forward push can aid insertion.
• When using a short StabiliT Introducer, the distal tip of the deflated balloon has
reached the distal end of the working cannula when the distal marker band on the
balloon shaft aligns with the proximal end of the cannula. When using the long
StabiliT Introducer, the distal tip of the deflated balloon has reached the distal end
of the working cannula when the proximal marker band on the balloon shaft aligns
with the proximal end of the cannula.
• Straight Balloons:
o While holding the balloon catheter in place, inflate to 44psi (3atm) to secure
balloon in position. Remove the stylet in the straight balloon catheter if desired.
• Steerable Balloons:
o The Arcadia steerable balloon catheter has a steering handle that enables the
steerable feature of the balloon. The arrow printed on the steerable handle
indicates the directionality of the steerable handle turning (clockwise) to
increase articulation.
o Begin turning the steering handle on the Arcadia steerable balloon catheter
clockwise to aid in directing the distal portion of the device when the distal
radiopaque marker of the balloon has exited the working cannula. Continue
advancing the balloon catheter and turning the steering handle simultaneously
to follow the access channel.
o The steering mechanism features a detectable hard stop when the maximum
articulation has been reached.
o While holding the balloon catheter in place, inflate to 44psi (3atm) to secure
balloon in position.
Arcadia balloon catheter Inflation
• Inflate the Arcadia balloon under continuous fluoroscopic image guidance.
• Increase the volume in small increments (0.25 – 0.5cc). Assess balloon position in
lateral and AP views before proceeding to further volume increase.
• Stop balloon inflation when the treatment goal is achieved, any part of the inflated
balloon contacts cortical bone, or the maximum inflation volume and/or maximum
inflation pressure have been reached (see Table 1).
Arcadia balloon catheter Removal
• Deflate the balloon before removal by pulling the inflation device plunger all the
way back and removing all contrast medium from the balloon.
• If using the Arcadia steerable balloon catheter, return the steering mechanism to
the starting position by turning the steering handle counter-clockwise before
removal until the hard stop is detected.
• If there is resistance, connect the locking syringe to the inflation port, pull the
syringe plunger back, locking it to create a vacuum, and resume the balloon
removal.
• Do not withdraw the balloon catheter unless it is fully deflated. Never withdraw the
balloon catheter against resistance. Determine the cause of resistance under
fluoroscopy and take the necessary remedial actions.
• Remove the Arcadia balloon catheter from the bone with a gentle motion.
Completion of Vertebral Augmentation or Balloon Kyphoplasty Procedure
Following void creation in a pathological fracture of the vertebral body, StabiliT®
Bone Cement may be introduced. Please refer to appropriate Instructions For Use for
cement delivery.
CEMENT RESISTANCE TECHNIQUE
If leaving an inflated balloon inside the vertebral body during cement fill on the
contra-lateral side, prior to injection of cement, ensure balloon volume is reduced by
1.0cc. It is recommended that the balloon is not placed in contact with the bone
cement for more than 5 minutes.
STERILIZATION
Gamma sterilized.
HOW SUPPLIED
The Arcadia balloon catheter package is supplied sterile in a peel-open package. A
locking syringe is also provided in a separate sterile, peel-open package. In the event
of damage to packaging, do not use and notify the manufacturer.
MATERIALS NOT SUPPLIED
• Inflation Syringe
• Contrast Media
• StabiliT Introducers
• PowerCURVE Navigating Osteotome
• VertecoR® Bone Drill
• StabiliT Bone Cement
NOTE: Inflation Syringe, StabilliT Introducers, PowerCURVE Navigating Osteotome,
VertecoR Bone Drill and StabiliT Bone Cement are available from Merit Medical.
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