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.
The IN.PACT™ AV DCB is contraindicated for use in:
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
Find more information, including other available configurations, for IN.PACT™ AV drug-coated balloon.
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