Drug-Coated Balloons (Peripheral)
5 devices
3 with evidence
Clinical Overview
Paclitaxel and sirolimus coated angioplasty balloons for peripheral arteries.
Procedures that use drug-coated balloons
Drug-Coated Balloons by manufacturer
10 product lines from 6 manufacturers registered with the FDA. Sizes are as listed in the FDA device identification database; confirm with the manufacturer's instructions for use.
| Manufacturer | Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|---|
| Lutonix, Inc. | LUTONIX Drug Coated Balloon LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm | Balloon Length: 40–300 mm; Length: 100–130 cm | 315 | Not stated |
| Boston Scientific Corporation | Ranger Paclitaxel-Coated PTA Balloon Catheter | Balloon Length: 30–200 mm; Balloon Diameter: 4–8 mm; Catheter Length: 80–150 cm | 100 | Not stated |
| Lutonix, Inc. | LUTONIX 035 Drug Coated Balloon PTA Catheter Lutonix® AV Drug Coated Balloon PTA Catheter 5x40x40 | Balloon Length: 40–100 mm | 76 | Not stated |
| Medtronic, Inc. | In.pact AV DCB IAV06004008P 06.00 L040 UL0800 US | Length: 40–120 mm; Outer Diameter: 4–12 mm | 69 | Not stated |
| Medtronic, Inc. | In.pact 018 DCB 018XL IPU06025020P D6.0 L250 UL0200 | Outer Diameter: 4–6 mm; Length: 40–150 mm; Balloon Diameter: 4–7 mm | 54 | Not stated |
| Medtronic, Inc. | IN.PACT Admiral DCB ADM06020013P 06.00 L200 UL1300 US | Length: 150–250 mm; Outer Diameter: 4–6 mm | 48 | Not stated |
| Spectranetics Corporation | Stellarex Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 100mm) x 135cm | Balloon Diameter: 4–6 mm; Balloon Length: 40–200 mm; Catheter Length: 80–135 cm | 42 | Not stated |
| Philips Image Guided Therapy Corporation | Stellarex 0.035" OTW drug-coated angioplasty balloon 4mm x 40mm x 80cm | Balloon Diameter: 4–6 mm; Balloon Length: 40–200 mm; Catheter Length: 80–135 cm | 42 | Not stated |
| Philips Image Guided Therapy Corporation | Stellarex Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 100mm) x 135cm | Balloon Diameter: 4–6 mm; Balloon Length: 40–200 mm; Catheter Length: 80–135 cm | 42 | Not stated |
| Surmodics, Inc. | SurVeil DCB SurVeil DCB 4.0mm x 150mm x 135cm | Balloon Diameter: 4–150 mm; Catheter Length: 135 cm; Balloon Length: 40–150 mm | 22 | Not stated |
| 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 | — |
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