Drug-Coated Balloons (Peripheral)
5 devices
3 with evidence
Clinical Overview
Paclitaxel and sirolimus coated angioplasty balloons for peripheral arteries.
| Device | Manufacturer | Pathway | Cleared | Evidence |
|---|---|---|---|---|
| lutonix 035 model 9004 and model 9010 | Lutonix | PMA | 2025 | 4 |
| lutonix r 035 drug coated balloon pta catheter Evidence | Lutonix | PMA | 2018 | 4 |
| stellarex 0 035 otw drug-coated angioplasty ballon | The Spectranetics | PMA | 2019 | — |
| optilume urethral drug coated balloon Evidence | Urotronic | PMA | 2022 | — |
| surmodics surveil drug-coated balloon Evidence | Surmodics | PMA | 2024 | — |