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Prepping the Device
NOTE: DO NOT REMOVE THE BALLOON PROTECTOR UNTIL AFTER THE AIR PURGING PROCESS
IS COMPLETED.
1. Attach a high pressure 3-way stopcock to the balloon inflation port.
2. Attach a 50cc or 60cc syringe filled with approximately 6cc-10cc of sterile normal saline and
inject 1-2cc's of the fluid into the catheter. Draw back on the syringe to apply full vacuum.
Repeat this procedure 3 or 4 times to insure total air evacuation. Close the stopcock.
3. Fill the inflation syringe with the desired volume (see Volume Compliance Chart) with a
solution of 1:8, or lower concentration (higher dilution), contrast medium to saline and
reattach the syringe.
4. Remove the balloon protector. If bubbles are seen inside the balloon upon removal of the
balloon protector, reapply the balloon protector and repeat step 2 and 3 above until the
bubbles are removed.
Performing the Procedure
1. First shape the distal portion of the guidewire tip into a broad loop to reduce the risk of
perforation and then advance under fluoroscopic guidance to the desired position within the
left ventricle.
2. Advance the balloon over the wire, through the introducer sheath, and across the valve
maintaining a vacuum during delivery, if possible, in order to maintain a minimal balloon
wrap profile.
3. Align the balloon's central marker bands with the valve annulus.
4. Rapid ventricular pacing can be used to aide in balloon fixation during inflation.
5. Rapidly inflate and deflate the balloon with the 50cc/60cc syringe. If pacing
was elected to be used, terminate after balloon deflation. If the balloon bursts, withdraw the
balloon by removing the balloon and sheath together as a unit, as described in the Warnings
section.
6. Repeat steps 3-5, if needed, until desired results are achieved, allowing sufficient time for
complete hemodynamic recovery between inflations. Maintain wire position throughout
the procedure.
7. Antiplatelet and anticoagulant therapy is recommended throughout the procedure to avoid
blood clot(s) which may result in embolization and vascular occlusion.
8. Remove the catheter while applying a continuous vacuum with the syringe and pulling back
slowly on the catheter while holding the introducer sheath firmly in place.
9. Apply a minimum of 30 minutes of compression to the insertion site after the system is
removed or place an approved vascular closure device to close the arteriotomy site.
1204-001 Revision C.1
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