Lutonix

Lutonix is a drug-coated balloon (DCB) catheter system designed for percutaneous transluminal angioplasty (PTA) in patients with obstructive lesions of the peripheral vasculature. The device consists of a standard balloon catheter coated with a non-polymeric formulation of the anti-proliferative drug paclitaxel, using polysorbate and sorbitol as excipients to facilitate drug transfer to the vessel wall. Upon inflation, the balloon delivers a therapeutic dose of paclitaxel (2 µg/mm²) directly to the arterial intima. Paclitaxel acts as a microtubule stabilizer, binding to tubulin to promote microtubule assembly and inhibit disassembly, which arrests the cell cycle in the G2/M phase. This mechanism effectively inhibits the migration and proliferation of vascular smooth muscle cells, thereby reducing neointimal hyperplasia and the risk of restenosis. Originally developed by Lutonix, Inc. and later acquired by C. R. Bard (now part of Becton Dickinson), the Lutonix 035 DCB was the first of its kind to receive FDA approval for treating femoropopliteal arteries and was subsequently approved for maintaining the patency of arteriovenous fistulae in dialysis patients.

Brand names

LutonixLutonix 035Lutonix035Lutonix-035Lutonix 014Lutonix014Lutonix-014

Other names

Lutonix DCBpaclitaxel-coated balloon