Drug-coated balloons
Stellarex
A sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device.
Stellarex models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| AB35SX040040080 | Balloon Diameter 4 mm; Balloon Length 40 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX040040135 | Balloon Diameter 4 mm; Balloon Length 40 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX040060080 | Balloon Diameter 4 mm; Balloon Length 60 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX040060135 | Balloon Diameter 4 mm; Balloon Length 60 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX040080080 | Balloon Diameter 4 mm; Balloon Length 80 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX040080135 | Balloon Diameter 4 mm; Balloon Length 80 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX040100080 | Balloon Diameter 4 mm; Balloon Length 100 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX040100135 | Balloon Diameter 4 mm; Balloon Length 100 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX040120080 | Balloon Diameter 4 mm; Balloon Length 120 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX040120135 | Balloon Diameter 4 mm; Balloon Length 120 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX040150080 | Catheter Length 80 cm; Balloon Length 150 mm; Balloon Diameter 4 mm | Not stated | Available |
| AB35SX040150135 | Catheter Length 135 cm; Balloon Length 150 mm; Balloon Diameter 4 mm | Not stated | Available |
| AB35SX040200080 | Catheter Length 80 cm; Balloon Length 200 mm; Balloon Diameter 4 mm | Not stated | Available |
| AB35SX040200135 | Catheter Length 135 cm; Balloon Length 200 mm; Balloon Diameter 4 mm | Not stated | Available |
| AB35SX050040080 | Balloon Diameter 5 mm; Balloon Length 40 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX050040135 | Balloon Diameter 5 mm; Balloon Length 40 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX050060080 | Balloon Diameter 5 mm; Balloon Length 60 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX050060135 | Balloon Diameter 5 mm; Balloon Length 60 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX050080080 | Balloon Diameter 5 mm; Balloon Length 80 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX050080135 | Balloon Diameter 5 mm; Balloon Length 80 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX050100080 | Balloon Diameter 5 mm; Balloon Length 100 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX050100135 | Balloon Diameter 5 mm; Balloon Length 100 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX050120080 | Balloon Diameter 5 mm; Balloon Length 120 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX050120135 | Balloon Diameter 5 mm; Balloon Length 120 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX050150080 | Catheter Length 80 cm; Balloon Length 150 mm; Balloon Diameter 5 mm | Not stated | Available |
| AB35SX050150135 | Catheter Length 135 cm; Balloon Length 150 mm; Balloon Diameter 5 mm | Not stated | Available |
| AB35SX050200080 | Catheter Length 80 cm; Balloon Length 200 mm; Balloon Diameter 5 mm | Not stated | Available |
| AB35SX050200135 | Catheter Length 135 cm; Balloon Length 200 mm; Balloon Diameter 5 mm | Not stated | Available |
| AB35SX060040080 | Balloon Diameter 6 mm; Balloon Length 40 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX060040135 | Balloon Diameter 6 mm; Balloon Length 40 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX060060080 | Balloon Diameter 6 mm; Balloon Length 60 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX060060135 | Balloon Diameter 6 mm; Balloon Length 60 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX060080080 | Balloon Diameter 6 mm; Balloon Length 80 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX060080135 | Balloon Diameter 6 mm; Balloon Length 80 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX060100080 | Balloon Diameter 6 mm; Balloon Length 100 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX060100135 | Balloon Diameter 6 mm; Balloon Length 100 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX060120080 | Balloon Diameter 6 mm; Balloon Length 120 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX060120135 | Balloon Diameter 6 mm; Balloon Length 120 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX060150080 | Catheter Length 80 cm; Balloon Length 150 mm; Balloon Diameter 6 mm | Not stated | Available |
| AB35SX060150135 | Catheter Length 135 cm; Balloon Length 150 mm; Balloon Diameter 6 mm | Not stated | Available |
| AB35SX060200080 | Catheter Length 80 cm; Balloon Length 200 mm; Balloon Diameter 6 mm | Not stated | Available |
| AB35SX060200135 | Catheter Length 135 cm; Balloon Length 200 mm; Balloon Diameter 6 mm | Not stated | Available |
FDA clearances
- PMA P160049 September 2019
Procedures that use drug-coated balloons
Frequently asked questions
What is Stellarex used for?
A sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device.
Who makes Stellarex?
Stellarex is made by Spectranetics Corporation. It is listed under drug-coated balloons in our device library.
What sizes does Stellarex come in?
Sizes listed for Stellarex: Balloon Diameter: 4–6 mm; Balloon Length: 40–200 mm; Catheter Length: 80–135 cm. Confirm availability with the manufacturer's instructions for use.
Is Stellarex MRI safe?
The FDA device database entry for Stellarex does not state its MRI safety status. Check the labeling before MRI.
Is Stellarex FDA cleared?
Stellarex is covered by FDA submission P160049.
How do I contact a Spectranetics Corporation sales representative?
Spectranetics Corporation has not listed representatives on LA Vascular yet. Visit the Spectranetics Corporation company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.