Spectranetics AngioSculpt X Mode D'emploi page 4

AngioSculpt®X Drug-Coated Percutaneous Transluminal Coronary
Angioplasty (PTCA) Scoring Balloon Catheter
Rapid Exchange (RX) Delivery System
English / English
INSTRUCTIONS FOR USE
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE.
TO OBSERVE ALL WARNINGS AND PRECAUTIONS MAY RESULT
IN COMPLICATIONS.
NOTE: These instructions apply to all balloon diameters and lengths.
STERILE: Sterilized with ethylene oxide gas. Non-pyrogenic. Do not
use if the package is open or damaged.
CONTENTS: One (1) AngioSculpt®X Drug-Coated PTCA Scoring
Balloon Catheter.
STORAGE: Store in a dry, dark, cool place.
I. DEVICE DESCRIPTION
1. PTCA Catheter Description
AngioSculpt®X Drug-Coated PTCA Scoring Balloon Catheter is a standard
PTCA catheter with a scoring balloon near the distal tip. The distal end
of the catheter has a conventional nylon-blend balloon and a nitinol
scoring element with three spiral struts that wrap around the balloon.
The struts create focal concentrations of dilating force, which minimize
balloon slippage and assist in the luminal expansion of stenotic arteries.
The scoring balloon is coated with a specialized formulation that
includes the anti-proliferative drug, paclitaxel. The drug-coated scoring
balloon is designed to expand to a speci ed diameter and length at a
speci ed pressure. Conventional radiopaque markers aid in positioning
the balloon in the stenosis.
Figure 1 shows the distal section of the catheter with the scoring
balloon. The proximal end of the balloon is connected to a balloon
in ation channel.
The product is o ered on a rapid exchange (RX) delivery platform, and
is available in balloon diameters of 2.0 – 3.5 mm in 0.5 mm increments,
and in scoring balloon lengths of 10, 15 and 20 mm. The catheter length
is approximately 137 cm and is compatible with 0.014-inch guide wires
and 6F guide catheters. The catheter is supplied sterile and is intended
for a single use.
Figure 1: Distal Section of AngioSculpt®X Drug-Coated PTCA
Scoring Balloon Catheter
2. Drug Coating Description
The drug coating is a non-polymer based formulation, consisting of
paclitaxel as the active pharmaceutical ingredient and the excipient
nordihydroguaiaretic acid (NDGA). The coating covers the working
balloon surface, part of the balloon cones, and the scoring element of the
AngioSculpt®X catheter at an average surface concentration of 3 g/mm
The key functional characteristic of the formulation is to allow for release
of paclitaxel to the tissue of the vascular wall during in ation.
II. INDICATIONS
The AngioSculpt®X Drug-Coated PTCA Scoring Balloon is indicated for the
treatment of hemodynamically signi cant coronary artery stenosis, including
in-stent restenosis, for the purpose of improving myocardial perfusion.
P009923-D 22NOV19 (2019-11-22)
III. CONTRAINDICATIONS
The AngioSculpt®X catheter should not be used for the following:
• Coronary artery lesions unsuitable for treatment by percutaneous
revascularization.
• Coronary artery spasm in the absence of a signi cant stenosis.
• Patients with known hypersensitivity to paclitaxel or paclitaxel-
related compounds.
• Patients who cannot receive recommended anti-platelet and/or
anticoagulant therapy
• Women who are breastfeeding, pregnant, or are intending to
become pregnant or men intending to father children.
IV. WARNINGS
• To reduce the potential for vessel damage, the in ated diameter
of the balloon should approximate the diameter of the vessel just
proximal and distal to the stenosis.
• PTCA in patients who are not acceptable candidates for coronary
artery bypass graft surgery requires careful consideration, including
possible hemodynamic support during PTCA, as treatment of this
patient population carries special risk.
FAILURE
• When the catheter is exposed to the vascular system, it should be
manipulated while under high quality uoroscopic observation.
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.
• Do not exceed the rated burst pressure (RBP) during balloon
in ation. The RBP is based on results of in-vitro testing. At least
99.9% of the balloons (with 95% con dence) will not burst
at or below their RBP. Use of a pressure monitoring device is
recommended to prevent over-pressurization.
• PTCA should only be performed at hospitals where emergency
coronary
performed in the event of a potential cardiovascular injury or
life-threatening complication.
• Use only the recommended balloon in ation medium. Never use air
or any gaseous medium to in ate the balloon.
• Proceed cautiously when using the AngioSculpt®X catheter in
a freshly deployed stent. The AngioSculpt®X catheter has not
been tested for post-dilatation of stents or lesions distal to freshly
deployed stents in clinical studies.
• Use the device prior to the expiration date speci ed on the package.
V. PRECAUTIONS
• Do not immerse the AngioSculpt®X catheter in a saline bath.
Contact with uids prior to insertion may compromise therapeutic
drug delivery. In order to ensure therapeutic drug delivery, replace
any device where the balloon has come into contact with uids
prior to use.
• The AngioSculpt®X catheter should be handled with dry sterile
gloves whenever possible prior to use. Care should be taken
to minimize contact with the coated balloon portion of the
AngioSculpt®X catheter during preparation and insertion.
• To ensure therapeutic drug delivery:
- Never in ate the AngioSculpt®X catheter prior to reaching the
target lesion.
- The AngioSculpt®X catheter should be advanced to the
target site in an e cient manner (i.e. ≤ 3 minutes) and
immediately in ated.
• Maintain balloon in ation for a minimum of 30 seconds.
• Predilatation of the lesion with an uncoated standard PTCA balloon
should be performed.
• Always advance and retrieve the AngioSculpt®X catheter under
negative pressure. Whenever possible, the AngioSculpt®X catheter
should be the nal treatment of the vessel.
.
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• The AngioSculpt®X catheter is intended to treat a single lesion in a
single patient; do not re-use the AngioSculpt®X catheter to dilate
additional lesions.
• Prior to angioplasty, examine the catheter to verify functionality,
catheter integrity and to ensure that its size and length are suitable
for the speci c lesion for which it is to be used.
• Only physicians trained in the performance of percutaneous
transluminal
AngioSculpt®X catheter.
artery bypass graft surgery
coronary angioplasty
can be quickly
should use the
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