Contraindications:
The Lutonix™ Catheter is contraindicated for use in:
1) Patients who cannot receive recommended anti-platelet and/or anticoagulant therapy (SFA).
2) Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children over the next to two 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.
3) 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 paclitaxelcoated 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. See Section 10.1 for further information.
1) Contents supplied STERILE using ethylene oxide (EO) process. Do not use if sterile barrier is damaged or opened prior to intended use.
2) Do not use after ‘Use by’ date.
3) Do not use if product damage is evident.
4) 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:
4a) Compromising the structural integrity of the device and/or device failure which, in turn, may result in patient injury, illness or death.
4b) 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.
5) 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.
6) 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.
7) 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:
General precautions:
1) The Lutonix™ Catheter should only be used by physicians trained in percutaneous interventional procedures.
2) Consideration should be given to the risks and benefits of use in patients with a history of non-controllable allergies to contrast agents.
3) The safety and effectiveness of the Lutonix™ Catheter have not been established for treatment in cerebral, carotid, coronary, or renal vasculature.
4) For SFA application, the safety and effectiveness of using more than four Lutonix drug coated balloons or a maximum drug coating quantity of approximately 15.1 mg paclitaxel in a patient has not been clinically evaluated.
5) For AV Fistula application, 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
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