IPU04025013P

IN.PACT™ 018 and IN.PACT™ Admiral™ drug-coated balloons shown side-by-side with blue and purple bubbles

Indications, Safety, and WarningsInstructions for useThe 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.ContraindicationsThe IN.PACT Admiral™/IN.PACT™ 018 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 drug coated balloon.

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 and effectiveness of using multiple IN.PACT Admiral™/IN.PACT™ 018 DCBs with a total drug dosage exceeding 34,854 μg of paclitaxel in a patient has not been clinically evaluated.

Precautions

Assess risks and benefits before treating patients with a history of severe reaction to contrast agents.

Administer appropriate drug therapy to the patient according to standard protocols for PTA before insertion of the dilatation catheter.

Take precautions to prevent or reduce clotting when any catheter is used. Flush and rinse all products entering the vascular system with heparinized normal saline or a similar solution. For the DCB catheter, flush the guidewire lumen through the guidewire port with heparinized normal saline until the fluid exits the distal tip. Do not rinse or wipe the DCB catheter.

Identify allergic reactions to contrast media and antiplatelet therapy before treatment and consider alternatives for appropriate management prior to the procedure.

This product is not intended for the expansion or delivery of a stent.

This product is not intended for pre-dilation or 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 diameter of the vessel just distal to the lesion.

Potential adverse effectsThe 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

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