Access catheter LUTONIX® 018

PTAblood vesselballoon

LUTONIX® 018 Drug Coated Balloon PTA Catheter Deliver More with the Only 018 DCB Features The LUTONIX® 018 DCB is designed to: Perform over small guidewires (up to .018”) Reduce guidewire exchanges Enable alternative access Built on the proven ULTRAVERSE™ 018 platform, LUTONIX® 018 features: Enhanced Pushability – Reinforced inner lumen provides axial strength Improved Visibility – Larger, dual distal marker bands on long lengths GeoAlign® Marking System – Facilitates simple repeat catheter alignment at the lesion With a crossing profile 20% lower than the lowest profile 035 DCB1, LUTONIX® 018 was built to: Cross tight lesions Navigate tortuous anatomy Reliably deliver drug to complex lesions Indications for Use: The LUTONIX® 018 Drug Coated Balloon PTA catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 300mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7mm. The LUTONIX® 018 Drug Coated Balloon PTA catheter is indicated for percutaneous transluminal angioplasty, after pre-dilatation, for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistulae that are 4 mm to 7 mm in diameter and up to 80 mm in length. Contraindications: The LUTONIX® Catheter is contraindicated for use in: 1) Patients who cannot receive recommended anti-platelet and/or anticoagulant therapy (SFA). 2) Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children over the next to two years.