Spectranetics Stellarex Gebrauchsanweisung Seite 2

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INSTRUCTIONS FOR USE
DEVICE DESCRIPTION
PTA Catheter
The Stellarex™ 0.035" OTW drug-coated angioplasty balloon (Stellarex balloon) consists of an over-the-wire
(OTW) dual lumen catheter with a distally mounted semi-compliant in atable balloon and an atraumatic
tapered tip. The balloon is coated with a proprietary coating containing the drug paclitaxel.
Drug coating
Marker band (x2)
The catheter is compatible with a 0.035" (0.89 mm) guidewire. Each device has a protective sheath over the
drug-coated balloon portion of the catheter. A compliance chart is included on the product label for each
device.
The balloon has two radiopaque markers for positioning the balloon relative to the treatment area. The
radiopaque marker bands indicate the working length of the balloon and facilitate uoroscopic visualization
during delivery and placement. The drug-coating on the balloon is a formulation consisting of paclitaxel as the
active pharmaceutical agent. The paclitaxel coating covers the working length of the balloon body.
Drug Coating
The drug coating consists of the active pharmaceutical ingredient paclitaxel and excipients. The drug coating
covers the working length of the balloon component of the catheter. The drug coating is evenly distributed
across the balloon surface at a concentration of 2µg/mm
is to allow for release of paclitaxel to the tissue of the vascular wall during balloon in ation.
INDICATIONS FOR USE
The Stellarex 0.035" OTW drug-coated angioplasty balloon is indicated for the treatment of de-novo or re-
stenotic lesions in the lower extremities to establish blood ow and to maintain vessel patency.
CONTRAINDICATIONS
The Stellarex balloon is contraindicated for use in:
• Patients with known hypersensitivity to paclitaxel or structurally related compounds.
• Patients who cannot receive recommended anti-platelet and/or anti-coagulation therapy.
• Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to
father children.
WARNINGS
• The Stellarex balloon is supplied STERILE for single use only. Do not reprocess or resterilize. Reprocessing
and resterilizing could increase the risk of patient infection and risk of compromised device performance.
• The Stellarex balloon should be used only by physicians who are experienced and knowledgeable of the
clinical and technical aspects of percutaneous transluminal angioplasty.
• Prior to use of the Stellarex balloon, physicians should read and understand the instructions for use.
Failure to follow the indications, contraindications, restrictions, warnings and precautions may result in
complications.
• Do not use after the "Use By" date.
• The Stellarex balloon contains paclitaxel, a known genotoxin. Do not use the Stellarex balloon in women
who are breastfeeding, pregnant or intending to become pregnant, or in men intending to father
children.
• Never use air or any gaseous medium to inflate the Stellarex balloon.
• When the Stellarex balloon is exposed to the vascular system, it should be manipulated under high
quality fluoroscopic observation.
• Do not manipulate the Stellarex balloon in an inflated state.
• If resistance is encountered at any time during the insertion procedure, do not force passage. Resistance
may cause damage to device or lumen. Carefully withdraw the catheter.
• Precautions to prevent or reduce clotting should be considered. Physician experience and discretion will
determine the appropriate anticoagulation therapy for each patient.
• The Stellarex balloon should be used with caution for procedures involving calcified lesions.
• Allergic reactions to contrast medium should be identified before PTA angioplasty.
• The outer foil pouch is not a sterile barrier. The inner Tyvek pouch is the product sterile barrier.
Do not allow the Tyvek inner pouch to contact the sterile field.
• The safety of utlizing multiple Stellarex balloons with a total drug dose greater than 9.4mg paclitaxel has
not been evaluated.
PRECAUTIONS
• The Stellarex balloon should not be inflated in excess of the rated burst pressure (RBP).
• Do not use contrast media that is contraindicated for intravascular use with this device.
• Carefully inspect the Stellarex balloon and package prior to use. Do not use the catheter if it is damaged
or if the size, shape or condition is unsuitable for the intended procedure.
• Do not immerse or wipe the balloon section of the Stellarex balloon with any fluid as the integrity of the
drug coating may be damaged or compromised. Replace any Stellarex balloon where the balloon has
come into contact with fluids prior to use.
• Use sterile gloves to handle the Stellarex balloon prior to use. Care should be taken to minimize contact
with the coated balloon portion of the device.
• Pre-dilatation of the target lesion is recommended for highly stenosed and difficult to cross lesions. Pre-
dilate using a PTA catheter undersized by at least 1 mm with respect to the reference vessel diameter. If
positioning of the Stellarex balloon is difficult while attempting to cross the lesion, remove the catheter
and attempt a second pre-dilatation.
• Avoid saline solution contact with the Stellarex balloon coating when flushing the wire lumen.
• Never inflate the Stellarex balloon outside the body or prior to reaching the target lesion as it may disrupt
the coating integrity.
• Do not attempt to pass the Stellarex balloon through a smaller French size guide catheter or introducer
sheath than indicated on the label. Refer to package label for guide catheter and introducer sheath
compatibility.
• For proper drug delivery to the target lesion, maintain inflation of the Stellarex balloon for a minimum
of 60 seconds. In order to optimize lesion dilatation, longer inflation times may be performed at the
discretion of the operator.
• Use of the Stellarex balloon has not been studied in conjunction with other interventional techniques
. The key functional characteristic of the drug coating
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• If provisional (bail out) stenting is required, a bare metal stent indicated for treatment of the
femoropopliteal arteries should be used.
• The optimal duration of antiplatelet therapy for each patient is at the discretion of the physician.
• After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted
medical practice and applicable local, state and federal laws and regulations.
USE IN SPECIAL POPULATIONS
The safety and e ectiveness of the Stellarex balloon has not been established in pediatric patients (< 18 years
of age).
Use of the Stellarex balloon in patients ≥ 18 years of age and older is at the discretion of the physician.
DRUG INFORMATION
Mechanism of Action
The Stellarex balloon coating contains paclitaxel, an anti-proliferative pharmaceutical that speci cally binds
to and stabilizes microtubules and the excipient polyethylene glycol. Paclitaxel a ects inhibition of smooth
muscle cell and broblast proliferation/migration as well as secretion of extracellular matrix by blocking
microtubule proliferation. The combination of these e ects results in the inhibition of neointimal hyperplasia
and therefore restenosis.
Drug Interactions
Formal drug interaction studies have not been conducted for the Stellarex balloon. The respective instructions
for use for all drugs used in conjunction with the Stellarex balloon should be consulted for interactions with
paclitaxel. Consideration should be given to the potential for systemic and local drug interactions in the vessel
wall in a patient who is taking a drug with known interactions to paclitaxel or when deciding to initiate drug
therapy in a patient who has been treated with the Stellarex balloon.
The metabolism of paclitaxel is catalyzed by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 and it is a
substrate of P-glycoprotein. Potential drug interactions may occur with any drug that a ects these isoenzymes.
In the absence of formal drug interaction studies, caution should be exercised when administering paclitaxel.
Carcinogenicity, Genotoxicity and Reproductive Toxicology
No long-term studies have been performed to evaluate the carcinogenic potential of the Stellarex balloon.
WARNING: The Stellarex balloon contains paclitaxel, a known genotoxin. Do not use the Stellarex
balloon in women who are breastfeeding, pregnant or intending to become pregnant, or in men
intending to father children.
POTENTIAL COMPLICATIONS / ADVERSE EVENTS
Adverse Events
Potential complications which may be associated with a peripheral balloon dilation procedure include, but may
not be limited to, the following:
• Abnormal heart rhythms
• Allergic reaction to contrast medium,
antiplatelet therapy, or catheter system
components (drug, excipients, and materials)
• Amputation/loss of limb
• Aneurysm
• Arrhythmias
• Arterio-venous fistula (AVF)
• Bleeding
• Death
• Embolism/Device embolism
• Fever
• Hematoma
• Hemorrhage
• Hypertension/Hypotension
Potential complications which may be associated with the addition of paclitaxel to a PTA balloon catheter
include, but may not be limited to, the following:
• Allergic/Immunological reaction to paclitaxel
• Alopecia
• Anemia
• Gastrointestinal symptoms (e.g. diarrhea, nau-
sea, pain, vomiting)
• Hemolysis
• Hematologic dyscrasia (including neutropenia,
leucopenia, thrombocytopenia)
PATIENT COUNSELING INFORMATION
Physicians should advise patients on the following:
• Risks associated with a PTA procedure
• Risks associated with a paclitaxel coated PTA catheter
• Pre- and post-procedure care including antiplatelet therapy
HOW SUPPLIED
The Stellarex balloon is supplied STERILE for single use only (ethylene oxide sterilization). The Stellarex balloon
is contained within an inner Tyvek pouch with an outer foil pouch. The pouches are contained within a single
unit box.
WARNING: The outer foil pouch is not a sterile barrier. The inner Tyvek pouch is the product sterile
barrier. Do not allow the Tyvek inner pouch to contact the sterile eld.
WARNING: The Stellarex balloon is supplied STERILE for single use only. Do not reprocess or resterilize.
Reprocessing and resterilizing could increase the risk of patient infection and risk of compromised
device performance.
STORAGE
The Stellarex balloon should be stored at room temperature in a dry location in its original packaging. The
device should be used prior to the "Use By" date printed on the device packaging.
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• Infection or pain at insertion site
• Inflammation
• Ischemia
• Occlusion
• Pain or Tenderness
• Pseudoaneurysm
• Renal failure
• Restenosis
• Sepsis/Infection
• Shock
• Stroke/CVA
• Thrombosis
• Vessel dissection, perforation, rupture or
spasm
• Histologic changes in vessel including inflam-
mation, cellular damage, or necrosis
• Myalgia/Arthralgia
• Peripheral neuropathy
• Rash
• Transfusion