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US Device Guide / Drug-Coated Balloons

Company Name Product Name Drug Type Drug Concentration (µg/mm2) Excipient Type Guidewire Compatibility (inch) Shaft Length (cm) Sheath Compatibility (F) Balloon Diameters (mm) Balloon Lengths (mm) US FDA Indicated Use
Medtronic In.Pact Admiral Paclitaxel 3.5 Urea 0.035 80, 130 5 (4 mm), 6 (5, 6 mm), 7 (7 mm) 4–7 40, 60, 80, 120, 150 Indicated for PTA, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 180 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4–7 mm
BD Interventional Lutonix 018 (SFA/popliteal indication; AVF indication for balloon lengths ≤ 100 mm only) Paclitaxel 2 Polysorbate, sorbitol 0.018 100, 130 4, 5 4–7 40, 60, 80, 100, 150, 220 Indicated for PTA, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4–7 mm; also indicated for PTA, after predilatation, for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistulae 4–7 mm in diameter and up to 80 mm in length
BD Interventional Lutonix 035 (AV indication) Paclitaxel 2 Polysorbate, sorbitol 0.035 40, 75, 100 5–9 4–12 40, 60, 80, 100 Indicated for PTA, after predilatation, for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistulas that are 4–12 mm in diameter and up to 80 mm in length
BD Interventional Lutonix 035 (SFA/popliteal indication) Paclitaxel 2 Polysorbate, sorbitol 0.035 75, 130 5, 6 4–7 40, 60, 80, 100, 120, 150, 220 Indicated for PTA, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4–7 mm
Philips Stellarex Drug-Coated Angioplasty Balloon Paclitaxel, polyethylene glycol (PEG) 2 Polyethylene glycol (PEG) 0.035 80, 135 6 4, 5, 6 40, 60, 80, 100, 120, 150, 200 De novo and restenotic lesions in the superficial femoral or popliteal arteries

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