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Lutonix 035 AV Drug Coated Balloon PTA Catheter
- Development stage
- Unknown
- Lead developer
- BD
- Modality
- Small Molecules, Device-based Delivery → Drug Delivery Systems
- Administration
- Percutaneous
01
Overview
The Lutonix 035 AV Drug Coated Balloon (DCB) is a combination product consisting of a percutaneous transluminal angioplasty (PTA) catheter and a paclitaxel coating. Developed by C.R. Bard (now part of BD), it is specifically indicated for the treatment of stenotic lesions in dysfunctional native arteriovenous (AV) fistulae in patients with end-stage renal disease. The balloon is coated with a low-dose formulation of paclitaxel (2 µg/mm²) in a polysorbate and sorbitol excipient. Paclitaxel acts as an antiproliferative agent that inhibits neointimal hyperplasia, the primary cause of restenosis after balloon angioplasty. It was the first drug-coated balloon to receive FDA approval for this specific indication in 2017, based on the LUTONIX AV Clinical Trial which demonstrated extended time to reintervention compared to standard angioplasty.
- Brand names
- Lutonix 035 AVLutonix035 AVLutonix-035 AV
- Other names
- Lutonix DCBLutonix AV DCBLutonix 035 AV DCBLutonix035 AV DCBLutonix-035 AV DCB
02
Targets
TUBB (Tubulin (alpha and beta subunits))
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