Boston Scientific Vessix Catheter Mode D'emploi page 4

• The catheter lumen must be flushed prior to treatment with heparinized saline.
C. Renal Artery Access
1. Use a femoral puncture technique to insert an appropriately sized (5 or 6F) introducer sheath. Heparinize intravenously according to the standard
practices of the institution.
2. Perform a diagnostic aortogram to obtain visual confirmation of all renal arteries. A selective arteriogram should be performed on each renal
artery using a diagnostic catheter in order to determine the appropriate Vessix™ Catheter to be used for the treatment, per the table below:
Artery Size ->
4.0 mm balloon
5.0 mm balloon
6.0 mm balloon
7.0 mm balloon
3. The short sheath should be exchanged for an 8F guiding sheath.
4. The 8F guiding sheath should be placed near the ostium of the renal artery using a no-touch technique. Do not cannulate the renal ostium with
the 8F guiding sheath.
5. Introduce a 0.014 inch or 0.018 inch guide wire into the renal vasculature via the guiding sheath. The wire should be placed beyond the
bifurcation. Once access is secured, the Vessix Catheter should be prepared for treatment.
D. Preparation for Use
1. Using sterile techniques, open the sterile package, unfasten the electrical connector, free the lead, and then gently remove the catheter from the
catheter hoop.
2. Slide the protective sheath off the balloon and inspect the device to ensure it has not been damaged. Remove the stainless steel shipping
mandrel from the guide wire lumen.
3. Connect the catheter to the generator, which resides outside of the sterile field. The catheter-to-patient extension cable connection should
remain outside of the sterile field.
4. Upon catheter to generator joining, the generator screen will confirm the catheter has been connected. (Figure 2 below)
5. Do not attempt to pull or reshape the electrical contacts mounted on the exterior of the balloon. Flush the guide wire lumen with normal
heparinized saline in a routine manner. Care should be taken not to disrupt the circuitry on the balloon.
6. Attach a 10-20 cc syringe containing 2 parts normal heparinized saline to 1 part contrast to the inflation port of the catheter hub. Apply negative
pressure for 20-30 seconds.
7. Release pressure slowly, allowing negative pressure to draw saline into the balloon lumen.
8. It is recommended to apply negative pressure again for 20-30 seconds prior to detaching the syringe.
9. Detach the syringe, leaving a meniscus of saline in the inflation port of the hub.
10. Prepare the inflation device with 2 parts normal heparinized saline to 1 part contrast, and purge to remove all air from the inflation device.
11. Attach the inflation device to the inflation port directly, ensuring no air bubbles remain at the connection.
12. Leave the inflation device on ambient pressure (neutral position). Do not pull negative pressure (vacuum) on the inflation device after balloon
preparation or prior to delivering the catheter.
Figure 2
E. Placement of Vessix Catheter
1. Maintain neutral pressure on the inflation device. Insert the catheter over the guide wire through the sheath. If resistance is encountered, do
not force passage. Resistance may indicate a problem and may result in damage to the balloon circuitry if it is forced. If significant resistance is
encountered, remove and replace the catheter.
2. Advance the catheter over the guide wire until the balloon is fully inside the renal artery, and the distal electrode is located 3 - 5 mm proximally to
the first bifurcation, using direct fluoroscopic visualization. Do not torque the catheter during insertion or placement.
3. Utilize the proximal and distal electrodes on the balloon as a reference to optimally position the catheter.
Black (K) ∆E ≤5.0
Recommended Catheter Sizing Table
3.0 – 4.0 mm 3.8 – 5.0 mm
Yes
x Yes
x
x
4.7 – 6.0 mm
x x
x
x Yes
x x
4
5.6 – 7.0 mm
x
x
x
Yes