IN.PACT™ AV Drug-Coated Balloon ISW
Indications for use
The IN.PACT™ AV paclitaxel-coated PTA balloon catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.
Contraindications
The IN.PACT™ AV DCB is contraindicated for use in:
- Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries
- Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy
- Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
- Patients with known allergies or sensitivities to paclitaxel
- 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 whether there is a potential for adverse reaction in nursing infants from paclitaxel exposure.
Warnings
- Do not use air or any gaseous medium to inflate the balloon. Use only the recommended inflation medium (equal parts contrast medium and saline solution).
- Do not move the guidewire during inflation of the IN.PACT™ AV DCB.
- Do not exceed the rated burst pressure (RBP). The RBP is based on the results of in vitro testing. Use of pressures higher than RBP may result in a ruptured balloon with possible intimal damage and dissection.
- The safety of using multiple IN.PACT™ AV DCBs with a total drug dosage exceeding 15,105 μg paclitaxel has not been evaluated clinically.
Precautions
- Assess risks and benefits before treating patients with a history of severe reaction to or inability to tolerate contrast agents. Identify allergic reactions to contrast media and antiplatelet therapy before treatment and consider alternatives for appropriate management prior to the procedure.
- Administer appropriate drug therapy to the patient according to standard protocols for PTA before insertion of the dilatation catheter.
- Do not rinse or wipe the IN.PACT™ AV DCB catheter.
- Handle the product with caution to avoid any damage to the balloon coating or folded balloon.
- This product is not intended for the expansion or delivery of a stent or graft.
- Do not use the IN.PACT™ AV DCB for pre-dilatation or for post-dilatation.
- Do not expose the product to organic solvents such as alcohol.
- To reduce the potential for vessel damage, the inflated diameter of the balloon should approximately match the inner diameter of the vessel just distal to the lesion.
Potential adverse effects
The potential adverse events associated with use of the device include but are not limited to: Abrupt vessel closure, allergic reaction, arrhythmias, arterial or venous aneurysm, arterial or venous thrombosis, death, dissection, embolization, hematoma, hemorrhage, hypotension/hypertension, infection, ischemia or infarction of tissue/organ, loss of permanent access, pain, perforation or rupture of the artery or vein, pseudoaneurysm, restenosis of the dilated vessel, shock, stroke, and vessel spasms or recoil.
Potential adverse events not captured above that may be unique to the paclitaxel drug coating include, but are not limited to: allergic/immunologic reaction, alopecia, anemia, gastrointestinal symptoms, hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia), hepatic enzyme changes, histologic changes in vessel wall, including inflammation, cellular damage, or necrosis, myalgia/arthralgia, myelosuppression, and peripheral neuropathy. Refer to the Physician’s Desk Reference for more information on the potential adverse effects observed with paclitaxel.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, at www.medtronic.com/manuals or contact a Medtronic representative.
US-CV-2601736 v1.0
