Drug-coated balloons
Stellarex 0.035" OTW drug-coated angioplasty balloon
by Philips Image Guided Therapy Corporation
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 0.035" OTW drug-coated angioplasty balloon 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 | Balloon Diameter 4 mm; Balloon Length 150 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX040150135 | Balloon Diameter 4 mm; Balloon Length 150 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX040200080 | Balloon Diameter 4 mm; Balloon Length 200 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX040200135 | Balloon Diameter 4 mm; Balloon Length 200 mm; Catheter Length 135 cm | 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 | Balloon Diameter 5 mm; Balloon Length 150 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX050150135 | Balloon Diameter 5 mm; Balloon Length 150 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX050200080 | Balloon Diameter 5 mm; Balloon Length 200 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX050200135 | Balloon Diameter 5 mm; Balloon Length 200 mm; Catheter Length 135 cm | 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 | Balloon Diameter 6 mm; Balloon Length 150 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX060150135 | Balloon Diameter 6 mm; Balloon Length 150 mm; Catheter Length 135 cm | Not stated | Available |
| AB35SX060200080 | Balloon Diameter 6 mm; Balloon Length 200 mm; Catheter Length 80 cm | Not stated | Available |
| AB35SX060200135 | Balloon Diameter 6 mm; Balloon Length 200 mm; Catheter Length 135 cm | Not stated | Available |
FDA clearances
- PMA P160049 September 2019
Procedures that use drug-coated balloons
Frequently asked questions
What is Stellarex 0.035" OTW drug-coated angioplasty balloon 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 0.035" OTW drug-coated angioplasty balloon?
Stellarex 0.035" OTW drug-coated angioplasty balloon is made by Philips Image Guided Therapy Corporation. It is listed under drug-coated balloons in our device library.
What sizes does Stellarex 0.035" OTW drug-coated angioplasty balloon come in?
Sizes listed for Stellarex 0.035" OTW drug-coated angioplasty balloon: 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 0.035" OTW drug-coated angioplasty balloon MRI safe?
The FDA device database entry for Stellarex 0.035" OTW drug-coated angioplasty balloon does not state its MRI safety status. Check the labeling before MRI.
Is Stellarex 0.035" OTW drug-coated angioplasty balloon FDA cleared?
Stellarex 0.035" OTW drug-coated angioplasty balloon is covered by FDA submission P160049.
How do I contact a Philips Image Guided Therapy Corporation sales representative?
Philips Image Guided Therapy Corporation has not listed representatives on LA Vascular yet. Visit the Philips Image Guided Therapy 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.