| 25 INDICATIONS FOR USE: The LUTONIX ® 035 Drug Coated Balloon PTA catheter is indicated for percutaneous transluminal angioplasty, after
pre-dilatation, of de novo or restenotic lesions up to 150mm in length in native
superficial femoral or popliteal arteries with reference vessel diameters of
4-6mm. CONTRAINDICATIONS : The
LUTONIX ®
Catheter is contraindicated for use in: 1) Patients who cannot receive recommended
anti-platelet and/or anticoagulant therapy. 2) Women who are
breastfeeding, pregnant or are intending to become pregnant or men intending to father children. 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: 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 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: Compromising the
structural integrity of the device and/or device failure which, in turn, may result in
patient injury, illness or death. 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. This product should not be used in
patients with known hypersensitivity to paclitaxel or structurally related
compounds. 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 more than two
Lutonix drug coated balloons (i.e., a maximum drug coating quantity of approximately 7.6 mg paclitaxel) in a patient has not been clinically evaluated.
PRECAUTIONS : General Precautions: The
LUTONIX ® Catheter should only be used by physicians trained in 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. POTENTIAL ADVERSE EVENTS: Potential
adverse events which may be associated with a peripheral balloon dilatation procedure include: Additional intervention, allergic reaction to drugs, excipients or contrast medium, amputation/loss of limb, aneurysm or
pseudoaneurysm, arrythmias, embolization; hematoma; hemorrhage, including bleeding at the
puncture site, hypotension/hypertension, inflammation, occlusion, pain or
tenderness, pneumothorax or hemothorax, sepsis/infection, shock, 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: 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 and peripheral
neuropathy. Bard, Advancing Lives
and the Delivery of HealthCare and Lutonix are trademarks and/or registered trademarks of C. R. Bard, Inc., or an affiliate. Copyright © 2014, C. R. Bard, Inc. All Rights Reserved.
Please consult product labels and instructions for use for indications,
contraindications, hazards, warnings and precautions. RX Only. |