Safety and Risk Information

Indication for Use

The Lutonix™ Catheter is indicated for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistulae that are 4 mm to 12 mm in diameter and up to 80 mm in length. 

Contraindications

•     Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children over the next 2 years. It is unknown whether paclitaxel will be excreted in human milk and there is a potential for adverse reaction in nursing infants from paclitaxel exposure.

•     Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.

Warnings

•     A signal for increased risk of late mortality has been identified following the use of paclitaxel-coated balloons and paclitaxel-eluting stents for femoropopliteal arterial disease beginning approximately 2-3 years post-treatment compared with the use of non-drug coated devices. There is uncertainty regarding the magnitude and mechanism for the increased late mortality risk, including the impact of repeat paclitaxel device exposure. Inadequate information is available to evaluate the potential mortality risk associated with the use of paclitaxel-coated devices for the treatment of other diseases/conditions, including this device indicated for use in arteriovenous dialysis fistulae. Physicians should discuss this late mortality signal and the benefits and risks of available treatment options with their patients.

•     Contents supplied STERILE using ethylene oxide (EO) process. Do not use if sterile barrier is damaged or opened prior to intended use.

•     Do not use after the “Use by” date.

•     Do not use if product damage is evident.

•     The Lutonix™ Catheter is for use in one patient only; do not reuse in another patient, reprocess or resterilize. Risks of reuse in another patient, reprocessing, or resterilization include:

o   Compromising the structural integrity of the device and/or device failure which, in turn, may result in patient injury, illness or death.

o   Creating a risk of device contamination and/or patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to patient injury, illness or death.

•     Do not exceed the Rated Burst Pressure (RBP) recommended for this device. Balloon rupture may occur if the RBP rating is exceeded. To prevent over-pressurization, use of a pressure monitoring device is recommended.

•     Use the recommended balloon inflation medium of contrast and sterile saline (≤50% contrast). Never use air or any gaseous medium to inflate the balloon as this may cause air emboli in case of balloon burst.

•     This product should not be used in patients with known hypersensitivity to paclitaxel or structurally related compounds as this may cause allergic reaction (difficulty in breathing, skin rash, muscle pain). 

Precautions

•     The Lutonix™ Catheter should only be used by physicians trained in peripheral vascular percutaneous interventional procedures.

•     Consideration should be given to the risks and benefits of use in patients with a history of non-controllable allergies to contrast agents.

•     The safety and effectiveness of the Lutonix™ Catheter have not been established for treatment in cerebral, carotid, coronary, or renal vasculature.

•     The safety and effectiveness of using multiple Lutonix™ drug coated balloons that deliver greater than 7.6 mg paclitaxel in a patient has not been clinically evaluated.

•     The safety and effectiveness of the Lutonix™ Catheter used in conjunction with drug eluting stents or other drug coated balloons in the same procedure or following treatment has not been evaluated.

Note: Use with stent graft for bailout if needed in the same procedure following treatment with the Lutonix™ Catheter is permitted.

Device Handling Precautions 

•    Do not immerse the Lutonix™ Catheter in a saline bath.  Replace any device where the balloon has come into contact with fluids prior to use.

•    The coated balloon portion should be handled with dry sterile gloves whenever possible prior to use.

•    The balloon protector and wire lumen stylet should stay in place during preparation of the Lutonix™ Catheter and not be removed until just prior to placing over guidewire.

•    If difficulty is encountered while removing the balloon protector, a new Lutonix™ Catheter should be utilized.  Removing the balloon protector by force can cause a kink in the catheter shaft and lumen constriction may occur, affecting inflation/deflation of the balloon.

Device Use/Procedure Precautions 

•    •    To ensure therapeutic drug delivery:

o   Never inflate the Lutonix™ Catheter prior to reaching the target lesion.

o   The Lutonix™ Catheter should be advanced to the target lesion as quickly as possible (i.e. ≤ 30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (drug coated balloon to pre-dilatation balloon ratio of ≥ 1:1).  Note: Lutonix™ Catheter has RBP range of 10 to 12 atm, depending on balloon diameter. Refer to the balloon compliance chart on the product label.

o   Maintain balloon inflation for a minimum of 2 minutes.  The balloon may remain inflated as long as is required by the standard of care to achieve a good angioplasty outcome.

•    Vessel preparation of the target lesion, using appropriate vessel preparation method as determined by the physician to achieve residual stenosis of ≤ 30%, is required prior to the use of the Lutonix™ Catheter.  The use of ultra-high pressure (≥ 25 atm) balloons for pre-dilatation of the lesion is recommended.  However, no difference was noted in the primary endpoint outcomes for higher pressure dilatation (≥ 25 atm) as compared to lower inflation pressures.

•    Vessel preparation using only PTA for pre-dilatation was studied in the Lutonix™ AV study.  Other methods of vessel preparation, such as atherectomy, have not been studied clinically with the Lutonix™ Catheter in dysfunctional native arteriovenous dialysis fistulae.

•    After insertion, do not over-tighten the hemostatic adaptor (if used) around the Lutonix™ Catheter shaft as lumen constriction may occur, affecting inflation/deflation of the balloon.

•    Always advance and retrieve the Lutonix™ Catheter under negative pressure.

•    The Lutonix™ Catheter should always be manipulated under adequate visualization when in the body.

•    Do not continue to use the Lutonix™ Catheter if the shaft has been bent or kinked.

•    Whenever possible, the Lutonix™ Catheter should be the final treatment of the vessel; however, post-dilation is allowed with another PTA catheter or the previously-used Lutonix™ Catheter.  Alternatively, placement of a stent graft for bailout is allowed, if necessary.

•    Medication therapy should be administered according to current medical standards.  

Potential Adverse Events

Potential adverse events which may be associated with a PTA balloon dilation procedure include, but are not limited to, the following:

•    Additional intervention

•    Allergic reaction to drugs or contrast medium

•    Aneurysm or pseudoaneurysm

•    Arrhythmias

•    Embolization

•    Hematoma

•    Hemorrhage, including bleeding at the puncture site

•    Hypotension/hypertension

•    Inflammation

•    Loss of permanent access

•    Occlusion

•    Pain or tenderness

•    Sepsis/infection

•    Shock

•    Steal Syndrome

•    Stroke

•    Thrombosis

•    Vessel dissection, perforation, rupture, or spasm

Although systemic effects are not anticipated, refer to the Physicians’ Desk Reference for more information on the potential adverse events observed with paclitaxel. Potential adverse events, not described in the above source, which may be unique to the paclitaxel drug coating include, but are not limited to, the following:

•    Allergic/immunologic reaction to the drug coating (paclitaxel)

•    Alopecia

•    Anemia

•    Blood product transfusion

•    Gastrointestinal symptoms

•    Hematologic dyscrasia (including leukopenia, neutropenia, thrombocytopenia)

•    Hepatic enzyme changes

•    Histologic changes in vessel wall, including inflammation, cellular damage, or necrosis

•    Myalgia/Arthralgia

•    Myelosuppression

•    Peripheral neuropathy

Please consult product labels and instructions for use for indications, contraindications, hazards, warnings, and precautions. ℞ only

BD-80801v3