The IN.PACT™ Admiral™ and IN.PACT™ 018 drug-coated balloons (DCB) are proven treatments for femoropopliteal disease.
The IN.PACT Admiral™/IN.PACT™ 018 paclitaxel-coated PTA balloon catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.
The IN.PACT Admiral™/IN.PACT™ 018 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, access site pain, allergic reaction to contrast medium, antiplatelet therapy, or catheter system components (materials, drugs, and excipients), amputation/loss of limb, arrhythmias, arterial aneurysm, arterial thrombosis, arteriovenous (AV) fistula, death, dissection, embolization, fever, hematoma, hemorrhage, hypotension/hypertension, inflammation, ischemia or infarction of tissue/organ, local infection at access site, local or distal embolic events, perforation or rupture of the artery, pseudoaneurysm, renal insufficiency or failure, restenosis of the dilated artery, sepsis or systemic infection, shock, stroke, systemic embolization, vessel spasms or recoil, and vessel trauma which requires surgical repair.
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-2601742 v1.0
Find more information, including other available configurations, for IN.PACT™ Admiral™ and IN.PACT™ 018 drug-coated balloons.
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