Boston Scientific SYNERGY Mode D'emploi page 9

2. Verify that the stent is positioned between the proximal and distal balloon markers.
Check for bends, kinks and other damage. Do not use if any defects are noted.
note: Use caution while flushing guidewire lumen with flushing needle to avoid
damage to catheter tip.
note: Avoid manipulation of the stent during flushing of the guidewire lumen, as this
may disrupt the placement of the stent on the balloon.
note: Stent contact with any fluid is not recommended as there is a possibility of
initiating drug release. However, if it is absolutely necessary to flush the stent with
saline, contact time should be limited (1 minute maximum).
balloon preparation
step action
1. Prepare inflation device/syringe with diluted contrast medium.
2. Attach inflation device/syringe to stopcock; attach to inflation port. Do not bend the
hypotube when connecting to inflation device/syringe.
3. With tip down, orient stent system vertically.
4. Open stopcock to stent system; pull negative pressure for 15 seconds; release to
neutral for contrast fill.
5. Close stopcock to stent system; purge inflation device/syringe of all air.
6. Repeat steps 4 through 6 until all air is expelled. If bubbles persist, do not use product.
7. If a syringe was used, attach a prepared inflation device to stopcock.
8. Open stopcock to stent system.
9. Leave on neutral.
Delivery procedure
step action
1. Prepare the vascular access site according to standard practice.
2. Predilate the lesion/vessel with appropriate diameter balloon.
3. Maintain neutral pressure on inflation device attached to stent system.
4. Backload stent system onto proximal portion of guidewire while maintaining guidewire
position across target lesion.
5. Fully open rotating hemostatic valve to allow for easy passage of the stent and prevent
damage to the stent.
6. Carefully advance the stent system into the hub of the guide catheter. Be sure to keep
the hypotube straight. Ensure guide catheter stability before advancing the stent
system into the coronary artery.
note: If unusual resistance is felt before the stent exits the guide catheter, do not
force passage. Resistance may indicate a problem. Use of excessive force may result
in stent damage or stent dislodgment from the balloon. Maintain guidewire placement
across the lesion, and remove the stent system and guide catheter as a single unit.
7. Advance the stent system over the guidewire to target lesion under direct fluoroscopic
visualisation. Use the proximal and distal radiopaque balloon markers as a reference
point. Fully cover the entire lesion and balloon treated area. The stent should adequately
cover healthy vessel proximal and distal to the lesion. If the position of the stent is not
optimal, it should be carefully repositioned or removed (see also precautions, stent
system removal - pre-deployment). The inside edges of the marker bands indicate both
the stent edges and balloon shoulders. Expansion of the stent should not be undertaken if
the stent is not properly positioned in the target lesion segment of the vessel.
note: If unusual resistance is felt at any time during lesion access before stent
implantation, the stent system and the guide catheter should be removed as a single
unit (see also precautions, stent system removal - pre-deployment). Once the stent
delivery system has been removed, do not reuse.
8. Sufficiently tighten the rotating hemostatic valve. The stent is now ready to be deployed.
Deployment procedure
step action
1. Inflate the delivery system expanding the stent to a minimum pressure of
11 atm - 1117 kPa. Higher pressure may be necessary to optimise stent apposition to
the arterial wall. Accepted practice generally targets an initial deployment pressure
that would achieve a stent inner diameter of about 1.1 times the distal reference vessel
diameter (see Table 4.). Balloon pressure must not exceed rated burst pressure of
18 atm - 1827 kPa for the 2.25–2.75 mm sizes and 16 atm - 1620 kPa for the 3.00-4.00 mm
sizes (see Table 4.).
2. Maintain inflation pressure for 15-30 seconds for full expansion of the stent.
3. Deflate balloon by pulling negative pressure on inflation device until balloon is fully deflated.
4. Confirm stent position and deployment using standard angiographic techniques. For
optimal results, the entire stenosed arterial segment should be covered by the stent.
Fluoroscopic visualisation during stent expansion should be used in order to properly
judge the optimum expanded stent diameter as compared to the proximal and distal
coronary artery diameter(s). Optimal expansion requires that the stent be in full contact
with the artery wall.
5. If stent sizing/apposition requires optimisation, readvance the stent system balloon,
or another high-pressure balloon catheter of the appropriate size, to the stented area
using standard angioplasty techniques.
6. Inflate the balloon to the desired pressure while observing under fluoroscopy. Deflate the
balloon (refer to product labeling and/or see Balloon Compliance Chart supplied with device).
7. If more than one SYNERGY™ stent is needed to cover the lesion and balloon treated
area, it is suggested that, to avoid the potential for gap restenosis, the stents be
adequately overlapped. To ensure that there are no gaps between stents, the balloon
marker bands of the second SYNERGY stent should be positioned inside of the deployed
stent prior to expansion.
8. Reconfirm stent position and angiographic result. Repeat inflations until optimal stent
deployment is achieved, or remove stent delivery system for larger post-dilatation
balloon catheter.
removal procedure and completion
step action
1. Ensure balloon is fully deflated before delivery system withdrawal.
2. Fully open rotating hemostatic valve.
3. While maintaining guidewire position and negative pressure on inflation device,
withdraw delivery system.
4. Repeat angiography to assess the stented area.
5. If an adequate expansion has not been obtained, exchange back to the original stent
delivery catheter or exchange to another balloon catheter of appropriate balloon
diameter to achieve proper stent apposition to the vessel wall.
• The stent delivery balloon may be used for post-dilatation up to stent diameters
indicated on the compliance chart (Table 4).
• A post-dilatation balloon catheter may be used to expand the stent up to the post-
dilatation limits indicated in the following table.
post-Deployment Dilatation of stented segments
precaution: Do not dilate the stent beyond the limit tabulated below.
nominal stent Diameter (ID)
2.25 mm, 2.50 mm, 2.75 mm
3.00 mm, 3.50 mm
4.00 mm
*Max Stent Inner Diameter
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post-Dilatation Limits (ID)*
3.50 mm
4.25 mm
5.75 mm
Black (K) ∆E ≤5.0