BIOTRONIK Passeo-18 Lux Instrucciones De Uso página 5

Description
The Passeo-18 Lux Paclitaxel-releasing PTA balloon catheter
(hereinafter Passeo-18 Lux catheter) is indicated for dilatation of
stenotic segments in infrainguinal arteries with simultaneous release
of Paclitaxel to the vessel wall in order to reduce occurrence of a
restenosis of the treated vessel segment. The balloon surface of the
Passeo-18 Lux catheter is homogeneously coated with a delivery
matrix incorporating 3 µg Paclitaxel per mm² with a maximum amount
of 9.1 mg on the largest balloon (7.0x120 mm). Paclitaxel is delivered
to the vessel wall upon expansion of the balloon.
A sheath protects the balloon in order to keep its factory-made profile
and drug coating and is used as an insertion aid during insertion
through the introducer sheath.
The dilatation balloon is designed to inflate to a known diameter at a
specific inflation pressure consistent with the compliance chart on the
label. One radiopaque marker is located at each end of the balloon
to facilitate fluoroscopic visualization and positioning of the balloon
catheter towards and across the lesion. The Passeo-18 Lux catheter
includes a soft tapered tip to facilitate advancement of the catheter.
The Passeo-18 Lux catheter has two luer-ports at the proximal end.
One port (inflation port) serves for connecting an inflation device to
inflate/deflate the balloon. The other port enables flushing of the
guide wire lumen. The Passeo-18 Lux catheter has a hydrophobic
silicone coating on its outer surface. The Passeo-18 Lux catheter is
compatible with guide wire and introducer sheath sizes according to
the recommendations on the label.
Caution: The label indicates minimum introducer sheath sizes. If
Passeo-18 Lux is used in conjunction with long and/or braided
introducer sheaths a larger French size than indicated on the label
may be necessary to reduce friction.
How Supplied
Sterile. Non-pyrogenic. Device is sterilized with ethylene oxide. DO
NOT use if the package is opened or damaged or if any information
provided is obscured or damaged.
Contents
• One (1) Passeo-18 Lux catheter in a sealed, peel-open pouch.
• One (1) Instructions for Use Manual
Storage
Store in a dark, dry location at max. 25°C / 77°F.
With proper storage, the product may be used until the expiry date
stated on the packaging.
Indications
The Passeo-18 Lux catheter is indicated to dilate de novo or restenotic
lesions in the infrainguinal arteries.
Contraindications
Contraindications for this device and peripheral dilatation catheters
in general are:
• Lesions which are untreatable with PTA or other interventional
techniques.
• Inability to cross the target lesion with a guide wire.
• Allergy to contrast media.
• Haemorrhagic diathesis or another disorder such as gastrointestinal
ulceration or cerebral circulatory disorders which restrict the use of
platelet aggregation inhibitor therapy and anticoagulation therapy.
• The target stenosis is located distal to a stenosis ≥ 50% that cannot
be pre-treated because the drug coating could get lost during
crossing the proximal lesion.
• Total occlusion of the target vessel.
• Allergy, intolerance or hypersensitivity to Paclitaxel or structurally
related compounds and/or to the delivery matrix n-Butyryl tri-n-
hexyl citrate (BTHC).
• Pregnancy and women of child bearing age.
Warnings
• The Passeo-18 Lux catheter is not indicated for use in coronary,
cervical and intracranial arteries.
• The Passeo-18 Lux catheter is designed and intended for single use
only. Do NOT resterilize and/or reuse. Reuse of single-use devices
creates a potential risk of patient or user infections. Contamination
of the device may lead to injury, illness or death of the patient.
IFU Passeo-18 Lux Version D.indd 5
English Cleaning, disinfection and sterilization may compromise essential
material and design characteristics leading to device failure.
BIOTRONIK will not be responsible for any direct, incidental or
consequential damages resulting from resterilization or reuse.
• DO NOT use the Passeo-18 Lux catheter if the outer or the inner
package is damaged or if any information provided is obscured or
damaged.
• Use prior to the "use by" date
• DO NOT expose the Passeo-18 Lux catheter to organic solvents e.g.
alcohol.
• Use only an appropriate balloon inflation medium (e.g. 50:50
mixture by volume of contrast medium and saline). Never use air or
any gaseous medium to inflate the balloon.
• When the Passeo-18 Lux catheter is in the body, it should be
manipulated whilst under sufficient and/or high-quality fluoroscopy.
• DO NOT advance or retract the Passeo-18 Lux catheter unless the
balloon is fully deflated under vacuum. If strong resistance is met
during manipulation, stop the procedure and determine the cause of
the resistance before proceeding. Advancement by force may result
in damage to the vessel and/or laceration or separation of the guide
wire or dilatation catheter. This may necessitate recovery of device
fragments.
• DO NOT exceed the Rated Burst Pressure (RBP). The use
of a pressure monitoring device is mandatory to prevent
overpressurization.
• To reduce the potential of vessel damage, the inflated diameter of
the balloon should approximate the original diameter of the vessel
proximal and distal to the stenosis.
• Precautions to prevent or reduce clotting should be taken. Flush
or rinse all products entering the vascular system with sterile
isotonic saline or a similar solution prior to use. The use of systemic
heparinisation during the procedure is recommended.
Precautions
General precautions
• Before using the Passeo-18 Lux catheter, the benefits and risks for
each patient must be individually assessed.
• Only physicians thoroughly trained and educated in the performance
of percutaneous transluminal angioplasty (PTA) should use the
dilatation catheter.
Precautions related to the active substance
Paclitaxel
• The amount of Paclitaxel on the balloon surface corresponds
approximately to a few tenths of the quantity usually used in anti-
neoplastic treatment, which makes it rather improbable that
interactions with other drugs will occur. However caution should be
exercised when concomitantly administering known CYP3A4 and/or
CYP2C8 substrates (including Terfenadine, Cyclosporine, Lovastatin,
Midazolam, Ondansetron) or drugs with high PPB (especially
sulfonylureas, anticoagulants of the coumarin type,salicylic acid,
sulfonamides, digitoxin). For possible interactions with other
drugs within the scope of Paclitaxel administered for oncological
indications, the relevant instructions for use should be consulted.
A study of possible interactions with other drugs within the scope
of Paclitaxel in association with treatment accompanying drugs has
not been established.
• The implantation of a drug eluting stent or another drug releasing
balloon catheter at the same site should be avoided since an over-
dosage or interaction with the active agents cannot be excluded. The
use of devices as indicated above in a new subsequent intervention
respectively has not been evaluated.
• In case of the treatment of long lesions (longer than max. balloon
length available) the individual segments should be treated with only
one Passeo-18 Lux catheter. For each segment another Passeo-18
Lux catheter should be used. Overlapping with an already treated
segment should be avoided in order to prevent any local overdosing.
• It is recommended to use gloves, mouth, nose and eye protection in
the unlikely event that the active compound of the balloon coating
is released prior to insertion of the Passeo-18 Lux catheter into the
introducer sheath. Potentially the released particles may enter the
respiratory tract.
• The treating physician should balance the medical advantage of
treating a patient with a Paclitaxel-releasing balloon against the
risk of potential adverse events as described in section "Potential
Adverse Events/Complications".
• Paclitaxel-related systemic adverse events as described in the
complications section are not expected after treatment with a
single Passeo-18 Lux catheter. If more than 1 catheter is used in
the same patient make sure not to exceed a total dose of 12 mg
that was shown to be well tolerated in clinical studies. See the
table of available balloon sizes and associated max. drug loads for
reference.
• Possible exposure of the user to Paclitaxel can be minimized when
the Passeo-18 Lux catheter is used according to the IFU. Paclitaxel
is bound to the excipient BTHC on the balloon surface and it is
unlikely that it propagates through the air (e.g. like a powder or
dust) and beyond a radius of 1m. Nevertheless,all people handling
the Passeo-18 Lux catheter should wear gloves, mouth, nose and
eye protection and avoid any unprotected direct or indirect contact
(e.g through contaminated material or liquids).
• Hospitals and personnel handling the Passeo-18 Lux catheter
should take all of the appropriate precautions for handling and
disposal of the product (including packaging) and be trained in the
handling of cytostatic drugs.
• Paclitaxel is in potential a genotoxic (in particular aneugenic/
clastogenic) agent based upon its pharmacodynamic mechanism
of action, which is interference with the microtubule disassembly.
The relevance of this specific mechanism of genotoxicity for human
carcinogenity risk is currently not known.
Precautions related to special patient
populations and indications
• The risk associated with antiplatelet treatment should be taken into
account. Special consideration is required in patients with recent
active gastritis or PUD (Peptic Ulcer Disease).
• It is not possible to state the effects of the Passeo-18 Lux catheter
on the unborn child. No clinical data is available on the use of
the Passeo-18 Lux catheter in pregnant women, i.e. reproduction
relevant contraindications and risks are unknown.
• Pediatric use: The safety and effectiveness of the Passeo-18 Lux
catheter in pediatric patients have not been established.
• It is not known whether paclitaxel is excreted in human breast
milk. Studies in animals have shown transfer of paclitaxel into
milk. A toxic effect in a nursing infant cannot be excluded. In view
of the terminal half-life of 27 hours for paclitaxel in human plasma,
breastfeeding should be withheld for at least 6 days after treatment.
Procedure precautions
• Prior to use, the Passeo-18 Lux catheter should be examined to
verify functionality and ensure that its size is suitable for the specific
procedure for which it is to be used.
• It is recommended to use gloves, mouth, nose and eye protection in
the unlikely event that the active compound of the balloon coating
is released upon removal of the Passeo-18 Lux catheter from the
protection ring. Potentially, the released particles may enter the
respiratory tract.
• Exercise care during handling to reduce the possibility of accidental
breakage, bending or kinking of the Passeo-18 Lux catheter shaft.
• Use only guide wires with a maximum 0.018" (0.46 mm) diameter.
Use only with introducers of an appropriate size as specified on the
label.
• The label indicates minimum introducer sheath sizes. If the
Passeo-18 Lux catheter is used in conjunction with long and/or
braided introducer sheaths a larger French size than indicated on
the label may be necessary to reduce friction.
• The inflation diameter of the balloon must not exceed the diameter
of the artery proximal or distal to the stenosis.
• Keep the insertion aid in place while preparing and purging air from
the device.
• The raised portion must remain partially visible outside the
introducer during insertion.
• Once the proximal end of the balloon is within the introducer, slide
back the insertion aid out of the introducer sheath and towards the
hub of the Passeo-18 Lux catheter.
• DO NOT bend or squeeze the balloon portion of the device to prevent
delamination of the drug coating.
• DO NOT use the device if a vacuum cannot be held, as this indicates
a system failure.
• Pre-treatment of significant stenosis proximal to target lesion
is required to prevent delamination of the balloon coating during
crossing the lesion.
• Contact with liquids prior to insertion, touching of the balloon or
wiping of balloon surface should be strictly avoided, since this could
wash away or damage the balloon coating.
• It is recommended to maintain negative pressure whenever the
device is withdrawn.
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