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Note: Safety information provided is for the United States. Please refer to your region’s Instructions for Use for specific details.
This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at +1 763-514-4000 (Worldwide). Prior to use, refer to the Instructions for Use for indications, contraindications, side effects, suggested procedure, warnings, and precautions. This content is available electronically at www.manuals.medtronic.com.
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.
Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries
Potential adverse effects which may be associated with balloon catheterization may include, but are not limited to, the following: 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, vessel spasms or recoil.
Potential complications of peripheral balloon catheterization include, but are not limited to, the following: balloon rupture, detachment of a component of the balloon and/or catheter system, failure of the balloon to perform as intended, failure to cross the lesion. These complications may result in adverse effects.
Although systemic effects are not anticipated, potential adverse effects not captured above that may be unique to the paclitaxel drug coating include, but are not limited to, the following: 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, peripheral neuropathy.
Refer to the Physicians' Desk Reference for more information on the potential adverse effects observed with paclitaxel. There may be other potential adverse effects that are unforeseen at this time.
Please reference appropriate product Instructions for Use for a detailed list of indications, warnings, precautions and potential adverse effects. This content is available electronically at www.manuals.medtronic.com.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
FTSOP113326-84a