Spectranetics AngioSculpt X Mode D'emploi page 8

IX. DIRECTIONS FOR USE
Preparation and Use of the AngioSculpt®X Catheter
Prior to use of the AngioSculpt®X catheter, examine carefully for damage
and catheter integrity. Do not use if the catheter has bends, kinks, missing
components or other damage.
or damaged.
1. Pre-medicate patient with appropriate dual antiplatelet therapy,
anticoagulant, and coronary vasodilator therapy consistent with
institutional protocol for percutaneous coronary interventions.
2. Perform coronary angiogram in the view best demonstrating the
target lesion prior to device deployment.
3. Position 0.014" coronary guide wire of choice beyond the
target lesion.
4. Pre-dilate the lesion with an uncoated standard PTCA balloon sized
smaller than the reference vessel.
5. If multiple AngioSculpt®X catheters are required to complete
treatment, the sequentially used AngioSculpt®X catheters should
be minimally sized and positioned so that the balloons overlap
as necessary to cover the lesion and margins of the predilatation
segment. The AngioSculpt®X catheter should extend approximately
2 mm proximally and distally of the pre-dilatation segment.
Care should be taken not to extend the entire dilatation segment
unnecessarily. An example is shown in Figure 2.
Pre-Dilatation / Injury Segment
≈ 2 mm
Overlap as needed
Figure 2. Balloons are sized to overlap only as much as needed to
treat lesion appropriately
6. Using sterile technique, remove an appropriately sized (≤ 1.0 x
reference vessel diameter (RVD)) AngioSculpt®X catheter from the
sterile package and place on the sterile eld.
Caution: The AngioSculpt®X balloon should be handled with dry
sterile gloves whenever possible prior to use. Care should be
taken to minimize unnecessary contact with the coated balloon
portion of the AngioSculpt®X catheter during preparation
and insertion.
7. Remove the stylet from the guidewire lumen and the protective
tubing from the balloon.
8. Inspect the catheter to ensure that all components are intact.
9. Flush the guide wire lumen with saline, taking care to keep the
balloon dry.
Caution: Do not immerse the AngioSculpt®X catheter in a saline
bath. Replace any device if its balloon has come in contact with
uids prior to use.
10. Attach 20 cc syringe lled with 2-3 cc of radiographic contrast to the
catheter balloon in ation port.
11. Aspirate/remove air from the catheter balloon lumen using the
20 cc syringe lled with 2-3 cc of radiographic contrast and leave on
vacuum for 30 seconds.
12. Gently release vacuum from the 20 cc syringe and remove it from the
balloon in ation port.
13. Attach in ation device (inde ator),
radiographic contrast and normal saline, to the balloon in ation
port by creating a meniscus. Avoid introducing air bubbles into the
catheter balloon lumen.
14. Aspirate using the in ation device, locking in vacuum.
NOTE: All air must be removed from the balloon and displaced
with contrast medium prior to inserting into the body (repeat
steps 11-14 if necessary).
P009923-D 22NOV19 (2019-11-22)
Do not use if inner package is open
Lesion Length
lled with 50:50 mixture of
Caution: To ensure therapeutic delivery, never in ate the
AngioSculpt®X catheter prior to reaching the target lesion.
15. Advance the AngioSculpt®X catheter over the coronary guide wire
to the target lesion.
NOTE: When back loading the catheter onto the guide wire, the
catheter should be supported, ensuring that the guide wire
does not come in contact with the balloon. Do not advance or
retract the AngioSculpt®X catheter over the oppy portion of
the guide wire. Do not advance or retract the catheter unless
the balloon is fully de ated under vacuum. If resistance is met
during manipulation, determine the cause of the resistance
before proceeding.
Caution: To ensure appropriate drug delivery, the AngioSculpt®X
catheter should be advanced to the target site in an e cient
manner and immediately in ated. Maintain balloon in ation for
a minimum of 30 seconds.
16. Position the balloon relative to the lesion, ensuring coverage at least
2 mm proximally and distally beyond the margins of the predilatation
lesion segment, and in ate the balloon to the appropriate pressure
(reference Compliance Chart included in the product packaging).
17. In ate the
recommended protocol:
• 2 atmospheres
• Increase the in ation pressure by 2 atmospheres every 10-15
seconds until full device in ation is achieved
• May in ate to a maximum pressure that is < RBP at the discretion
of the physician (bearing in mind the estimated in ated diameter
≈ 2 mm
of the device at a given pressure)
18. Perform coronary angiogram (in the same view(s) as step 2) of the
target lesion following completion of device treatment.
19. To remove the AngioSculpt®X catheter, apply negative pressure to
the in ation device and con rm that the balloon is fully de ated.
The catheter should be retracted only by grasping the hypotube shaft.
NOTE: Do not rotate the catheter shaft in excess of 180 degrees
when the tip is constrained. Do not rotate the catheter luer hub
in excess of ve (5) turns during use. Catheter manipulation,
including advancement and retraction, should be performed by
grasping the catheter shaft.
20. Inspect all components to ensure that the catheter is intact.
Follow institutional procedures for disposal of biohazards. If device
malfunction occurs or any defects are noted on inspection, ush
the guide wire lumen and clean the outer surface of the catheter
with saline, store the catheter in a sealed biohazard bag, and
contact Spectranetics or the EC Authorized Representative for
further instructions.
NOTE: Whenever possible, the AngioSculpt®X catheter should
be the nal treatment of the vessel.
21. Remove the coronary guide wire and perform coronary angiography
(in the same view(s) as step 2) of the target lesion following
completion of all interventions.
22. Remove all catheters and manage the arterial access site according
to institutional protocol.
X. MANUFACTURER'S LIMITED WARRANTY
Manufacturer
PTCA Scoring Balloon Catheter is free from defects in material and
workmanship when used by the stated "Use By" date and when package
is unopened and undamaged immediately before use. Manufacturer's
liability under this warranty is limited to replacement or refund of
the purchase price of any defective AngioSculpt®X Drug-Coated
PTCA. Manufacturer will not be liable for any incidental, special,
or consequential damages resulting from use of the AngioSculpt®X
Drug-Coated PTCA. Damage to the AngioSculpt®X Drug-Coated
PTCA caused by misuse, alteration, improper storage or handling,
or any other failure to follow these Instructions for Use will void this
limited warranty. THIS LIMITED WARRANTY IS EXPRESSLY IN LIEU
OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
THE IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE. No person or entity, including
any authorized representative or reseller of Manufacturer, has the
authority to extend or expand this limited warranty and any purported
attempt to do so will not be enforceable against Manufacturer.
AngioSculpt®X balloon
warrants that the AngioSculpt®X
per the following
Drug-Coated
8