References - Boston Scientific EMERGE MONORAIL Mode D'emploi

note: To avoid kinking, advance the catheter slowly, in small increments, until the
proximal end of the guidewire emerges from the catheter.
F. Thoroughly aspirate and flush the guide catheter in preparation for introduction of the
catheter.
G. Carefully advance the catheter through the hemostatic adapter while the balloon is
fully deflated. If unusual resistance is felt, do not advance the catheter through the
adapter. Caution should be taken not to over tighten the hemostatic adapter around
the catheter shaft as lumen constriction may occur, affecting inflation/deflation of the
balloon.
note: To avoid kinking, advance the catheter slowly, in small increments, until the
proximal end of the guidewire emerges from the catheter.
H. Connect the side port of the guide catheter hemostatic adapter to the proximal
pressure recording/infusion line or manifold assembly, which permits proximal
pressure recording or infusion through the guide catheter.
I. Advance the catheter over the guidewire under direct fluoroscopic visualization and
position the balloon relative to the stenosis or stent to be dilated. Use the radiopaque
marker bands as a reference point. The outside edges of the marker bands indicate
the balloon shoulders on the 2.00-4.00 mm models; the 1.20-1.50 mm models have a
single central marker band. Balloon inflation should not be undertaken if the balloon is
not properly positioned within the stenosis or stent.
J. Simultaneous Use of Two Balloon Catheters in a Guide Catheter: Bench and
preclinical testing has shown that one 4.00 x 30 mm (or smaller) Monorail balloon
catheter and one 3.25 x 20 mm (or smaller) Monorail balloon catheter can be inserted
simultaneously into a 6F (minimum 0.070" ID) guide catheter and two 4.00 x 30 mm (or
smaller) Over-the-Wire balloon catheters can be inserted into an 8F (minimum 0.088"
ID) guide catheter with acceptable compatibility. These tests did not account for all
clinical situations and differing anatomy. Care should be used when attempting to use
two balloon catheters simultaneously in a guide catheter. Balloon catheters with a
diameter greater than those mentioned have not been tested for simultaneous use in a
single guide catheter.
3. Catheter Inflation
A. Inflate the balloon slowly to the appropriate pressure to perform PTCA or post-
dilatation of a stent. Maintain negative pressure on the balloon between inflations.
Do not exceed the rated balloon burst pressure. Refer to Table 2 or to the balloon
compliance chart. If difficulty is experienced during balloon inflation, do not continue
inflation; deflate and remove the catheter.
B. After completion of PTCA or post-dilatation of a stent, deflate the balloon by pulling
negative pressure on the inflation device until the balloon is fully deflated.
C. Confirm angiographic results using standard angiographic techniques. Fluoroscopic
visualization during balloon expansion should be used to properly judge the optimum
expanded balloon diameter as compared to the proximal and distal coronary artery
diameter(s). Repeat inflation of balloon until the desired result is achieved.
D. If catheter exchange is necessary, proceed to step 5 – Catheter Exchange Procedure
(Emerge™ Over-The-Wire Catheter) or step 6 – Catheter Exchange Procedure (Emerge
Monorail™ PTCA Catheter). Otherwise, proceed to step 4 – Catheter Removal.
4. Catheter Removal
A. Confirm with angiography that the lumen of the dilated artery has not abruptly
occluded. Ensure balloon is fully deflated.
B. While withdrawing the deflated catheter and guidewire from the guide catheter
through the hemostatic adapter, tighten the knurled knob on the hemostatic adapter.
C. The Emerge Monorail PTCA Catheter may be coiled once and secured using the
CLIPIT™ Clip provided in the catheter package. Only the hypotube should be inserted
into the CLIPIT clip; the clip is not intended for the distal end of the catheter. Remove
the CLIPIT Clip prior to the catheter being inserted in the patient's body.
Black (K) ∆E ≤5.0
note: Care should be taken not to kink or bend the shaft upon application or removal
of the coil clip.
5. Catheter Exchange Procedure (Emerge Over-The-Wire Catheter)
The Emerge Over-The-Wire Catheters typically require two operators to exchange. To
perform a catheter exchange, execute the following steps:
A. Loosen the knurled knob on the hemostatic adapter.
B. The primary operator holds the hemostatic adapter in one hand, while grasping the
catheter shaft in the opposite hand.
C. The secondary operator is positioned near the foot of the patient and should maintain
the guidewire position in the coronary artery by holding the guidewire stationary
and confirming guidewire position at all times under fluoroscopy while the primary
operator begins pulling the catheter out of the guide catheter.
D. Withdraw the deflated catheter until the catheter tip exits the hemostatic adapter.
E. Close the knurled knob on the hemostatic adapter and remove the catheter from the
guidewire while maintaining guidewire position across the stenosis or stent.
F. Prepare the next catheter to be used as described in the Catheter Preparation
section.
G. Back load the new catheter onto the guidewire as described under step 2 – Catheter
Advancement – and continue the procedure.
6. Catheter Exchange Procedure (Emerge Monorail PTCA Catheter)
The Emerge Monorail PTCA Catheters have been specifically designed for rapid, single
operator catheter exchanges. To perform a catheter exchange, execute the following
steps:
A. Loosen the knurled knob on the hemostatic adapter.
B. Hold the guidewire and hemostatic adapter in one hand, while grasping the catheter
shaft in the opposite hand.
C. Maintain the guidewire position in the coronary artery by holding the guidewire
stationary. Begin pulling the catheter out of the guide catheter while monitoring the
guidewire position under fluoroscopy.
D. Withdraw the deflated catheter until the opening in the guidewire lumen is reached
(approximately 25 cm proximal to the balloon catheter tip).
E. Carefully slide the flexible, distal portion of the catheter out of the hemostatic
adapter, and tighten the knurled knob onto the guidewire to hold it securely in place.
Completely remove the catheter from the guidewire while maintaining guidewire
position across the stenosis.
F. Prepare the next catheter to be used as described in the Catheter Preparation
section.
G. Back load the new catheter onto the guidewire as described under step 2 – Catheter
Advancement – and continue the procedure.

reFerences

The physician should consult current medical practice literature on PTCA, such as that
published by the American College of Cardiology/American Heart Association.
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