Lutonix™ 035 Drug Coated PTA Balloon - Peripheral angioplasty balloon catheter, drug-eluting

Intended purpose

Lutonix™ 035 Drug Coated Balloon Catheter is intended for Percutaneous Transluminal Angioplasty (PTA) and to deliver antiproliferative drug to the vessel wall. The Lutonix™ 035 Drug Coated Balloon Catheter is indicated for the treatment of stenotic or occlusive lesions in the femoropopliteal arteries, including in-stent restenosis, in patients with peripheral arterial disease and in dysfunctional native arteriovenous fistula or synthetic arteriovenous grafts.

Functional description

Consists of an over-the-wire catheter with a drug coated balloon fixed at the distal tip of the catheter. The balloon is coated with a specialized formulation that includes the drug, paclitaxel. The device is compatible with a 0.035" (0.89 mm) guidewire, with a low-profile, semi-compliant balloon formed to a low profile tapered tip to facilitate advancement of the catheter to and through the stenotic region of the vessel.